Writing and implementing effective SOP 2017

Writing and implementing effective SOP 2017
Event on 2017-09-21 09:00:00
Course "Writing and implementing effective SOP's" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps.
Even a standardized method, such as an ASTM or IP method, is insufficiently written to pass as a well-written and compliant SOP. The reasons why will be described, as will the steps needed to convert a standard method into an SOP.
The necessary steps both within the laboratory and within the supporting areas for implementation and revision of an SOP are complex and will be described. These include recordkeeping, safety, training, and other areas.

Why should you attend:

A poorly written and followed SOP is one of the most common non-compliances that an auditor finds. If you are a laboratory worker, a supervisor, or manager of a laboratory seeking or under GLP or ISO 17025, you should know how to create and maintain a good SOP. Will your SOPs pass an audit or will they become a non-compliance corrective action?

Who will benefit:

• Anyone that creates / maintains SOPs
• VP, Director, Manager of any dept that writes SOPs or performs training
• QA / QC
• Regulatory Affairs

Agenda:

Day 1 Schedule

Lecture 1: What is the intention and role of SOPs. What tasks require SOPs? The network of SOPs within the Lab.
Lecture 2: What are the compliance requirements for an SOP? Roles and responsibilities. Can a Standard method be used as an SOP?
Lecture 3: Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt.
Lecture 4: Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt (continued)

Day 2 Schedule

Lecture 1: Interplay within the lab to improve the draft SOP. Iterations?
Lecture 2: Implementation of the SOP.
Lecture 3: Monitoring and Assessing the SOP. When should an SOP be revised? Revising the SOP.
Lecture 4: Archiving and documentation. Which SOP to use when? Other requirements.

Speaker:

John C. Fetzer,
Founder and Principal, Consultant Fetzpahs Consulting

John C. Fetzer, has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bio analytical Chemistry.

Location: Baltimore, MD Date: September 21st & 22nd, 2017 and Time: 9:00 AM to 6:00 PM
Venue: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road – Linthicum, MD 21090

Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: ,295.00 From August 11 to September 16, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901140SEMINAR?eventful-September-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at The DoubleTree Baltimore-BWI Airport
890 Elkridge Landing Road – Linthicum, MD 21090
Linthicum Heights, United States

Supplier Management in FDA- and ISO-regulated Industry 2017

Supplier Management in FDA- and ISO-regulated Industry 2017
Event on 2017-09-14 09:00:00
Course "Supplier Management in FDA- and ISO-regulated Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies can spend significantly less time and money, and still be in control of their suppliers and in compliance with the regulations. This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation. The QSR/ISO requirements for supplier assessment will be defined as well. Attention will be paid to inclusion of risk management in across both supplier qualification and assessment, implementation of which will allow your company to devote value-added resources to these efforts. Significant time will be spent on discussion of the topic of supplier nonconformance, including how and when to issue the dreaded Supplier Corrective Action Request. Your supplier nonconformance handling process must be nonconfrontational, or even better, collaborative. If your company is too demanding of your suppliers, you risk alienating them or even worse losing them – try explaining that to your supply chain folks.

Why should you attend

Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations and guidance documents, especially for outsourced processes such as contract manufacturing, sterilization and testing, and also for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them – try explaining that to your supply chain folks!

Areas Covered in the Session:

• Supplier Selection
o Review of FDA requirements
o Review of ISO requirements
o Types of suppliers that must be qualified
o Defining critical suppliers
o Outsourced processes
o Recommended Practices
o Documentation requirements
o Use of Risk Assessment
o The Quality Agreement
o Common Pitfalls
• Supplier Assessment
o Review of FDA requirements
o Review of ISO requirements
o Case Study: A Hypothetical Supplier Assessment
o Recommended Practices
o Documentation requirements
o Use of Risk Assessment
o Common Pitfalls
• Supplier Nonconformance
o Types of supplier nonconformances
 Best Practices for Notification
 Best Practices for Handling
 Trending
 Evaluation of Supplier Response
 Tracking effectiveness
o Supplier Corrective Action Requests
 Pre-notification?
 Best Practices for Issuance
 Followup
 Evaluation/Acceptance of Supplier Response
 Tracking effectiveness
• Workshop: Review of Supplier Responses: Acceptable or UNacceptable?

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that are interested in implementing and maintaining a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:
• Supply chain management
• Buyers
• Purchasing management
• CAPA Coordinators
• Regulatory management
• QA management
• Executive management
• Internal auditors

Agenda:

Day 1 Schedule

Lecture 1: Introduction
Supplier Selection
• Review of FDA requirements
• Review of ISO requirements
• Types of suppliers that must be qualified
• Defining critical suppliers
• Outsourced processes
Lecture 2:
Supplier Selection (cont)
• Recommended Practices
• Documentation requirements
• Use of Risk Assessment
• The Quality Agreement
• Common Pitfalls
Lecture 3:
Supplier Assessment
• Review of FDA requirements
• Review of ISO requirements
• Case Study: A Hypothetical Supplier Assessment
• Recommended Practices
Lecture 4:
Supplier Assessment (cont)
• Documentation requirements
• Use of Risk Assessment
• Common Pitfalls

Day 2 Schedule

Lecture 1:
Supplier Nonconformance
• Types of supplier nonconformances
o Best Practices for Handling
o Best Practices for Notification
o Trending
o Evaluation of Supplier Response
o Tracking effectiveness
Lecture 2:
Supplier Nonconformance (cont)
• Supplier Corrective Action Requests
o Pre-notification?
o Best Practices for Issuance
o Followup
o Evaluation/Acceptance of Supplier Response
o Tracking effectiveness
Lecture 3:
Workshop
• Acceptability of Supplier Responses
Lecture 4:
Q&A – Conclusion

Speaker
Jeff Kasoff
Director of Regulatory Affairs, Life-Tech, Inc

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than 0 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS , his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Location: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 4:00 PM
Venue: DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA
Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: ,295.00 From August 11 to September 12, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901002SEMINAR?eventful-September-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at DoubleTree by Hilton San Diego Downtown
1646 Front St, San Diego, CA 92101, USA
San Diego, United States

Regulatory Requirements and Principles for Cleaning Validation 2017

Regulatory Requirements and Principles for Cleaning Validation 2017
Event on 2017-09-14 09:00:00
Course "Regulatory Requirements and Principles for Cleaning Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.
The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan" and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.

Why you should attend:

Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.
Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.

Areas Covered in the Session:

• Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
• Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
• Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
• Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies

Who Will Benefit:

Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.
Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.
• Senior Quality Managers
• Quality Professionals
• Production Supervisors
• Validation Engineers
• Process Owners
• Quality Engineers
• Quality Auditors

Agenda:

Day 1 Schedule

Lecture 1:
FDA Requirements and Industry Standard Practices
Lecture 2:
How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters
Lecture 3:
How to Develop a Cleaning Validation Policy/Program
Lecture 4:
How to Implement a Robust Cleaning Validation Plan

Day 2 Schedule

Lecture 1:
Laboratory Issues in Cleaning
Lecture 2:
Microbiological aspects of a cleaning validation program for manufacturing equipment
Lecture 3:
Keys to Cleaning Validation Maintenance – Remaining Compliant
Lecture 4:
Current FDA concerns about validation of cleaning processes

Speaker
Joy McElroy
Principle Consultant, Maynard Consulting Company

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Up John performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.
Now with 12 years experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.
Joy specializes in Equipment Qualification, Cleaning Validation,Sterilization, Environmental Monitoring, and GMP Compliance Auditing

Location: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON, San Diego, CA
Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: ,295.00 From August 11 to September 12, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901170SEMINAR?eventful-September-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at San Diego, California, United States
San Diego, California, United States
San Diego, United States

Compliance Boot Camp 2017

Compliance Boot Camp 2017
Event on 2017-09-14 09:00:00
Course "Compliance Boot Camp" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance.

In this seminar, we will discuss:

• Regulatory Expectations
• How to plan, structure, and implement a quality system
• Common problems and lessons from 483 and warning letters
• Red-flags that your QS is not effective
• Audit for self-awareness
• Risk analysis and management techniques
• CAPA, continuous improvement, and six sigma
• Performance monitoring
• Culture, Management Responsibility, and maturity
• Key Quality System elements and linkages

Why should you attend:

This seminar will help you understand regulatory requirements and how to translate them into a quality system that is both effective and efficient. You'll learn how to plan, structure, and implement a quality system specific for your business needs. We'll explore the capabilities that every medical device company needs to ensure quality products and a compliant quality system. We'll discuss how to create a quality strategy and plans. Will discuss methods to identify, prioritize, and analyze risks. Then will move on to continuous improvement, six sigma, and Corrective and Preventive Action to address issues within your Quality System. You'll learn how to effectively communicate and escalate risk as well as monitor performance and progress.
This seminar can help you get your quality system off to a good start and avoid common problems including MDRs, recalls, 483s, and warning letters!
The expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them. This seminar will allow you to interact personally with an industry expert with over 30 years' experience in medical devices. The instructor has worked in manufacturing, design, quality and compliance at industry leaders like GE, Johnson and Johnson, and Medtronic. She has traveled throughout the world developing, auditing, and improving quality systems.

Learning Objectives:

This 2-day seminar will cover the following areas:
• Quality System Expectations
• Quality System Structure
• Strategy and Planning
• Risk management in your quality system
• Case for Quality
• Inspection preparedness and management
• Monitoring and metrics
• Creating a quality strategy and plans

Who will benefit:

• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Auditors
• Auditor Managers
• Compliance Managers
• Quality Managers
• CAPA Specialists
• Quality and Compliance directors for Medical Device companies
• General Managers and Executives wanting to use Compliance and Quality as a competitive strength

Agenda:

Day 1 Schedule

Lecture 1:
Overview
Lecture 2:
Introductions
Lecture 3:
Regulatory expectations
Lecture 4:
Quality Systems requirements for medical devices
Lecture 5:
Quality System structure and writing SOPs
Lecture 6:
Roles and Responsibilities
Lecture 7:
Management Responsibility and a Culture of Quality
Lecture 8:
Cost of Quality
Lecture 9:
Key Capabilities for Success
Lecture 10:
Metrics and performance monitoring
Lecture 11:
Maturity Modeling

Day 2 Schedule

Lecture 1:
An effective auditing program is a key to self-awareness
Lecture 2:
CAPA and root cause analysis – essentials for improvement
Lecture 3:
Six Sigma for Quality and Compliance
Lecture 4:
Management Review
Lecture 5:
Inspection preparedness and management
Lecture 6:
Red Flags and Warning Signs
Lecture 7:
Best Practices
Lecture 8:
Risk Management for Compliance
Lecture 9:
Creating a strategy and quality plan

Speaker:
Susanne Manz
Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc.

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at industry leaders like GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Worldwide Director of Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world conducting audits and helping companies to understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM.
She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.

Location: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA

Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: ,295.00 From August 11 to September 12, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link -http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901150SEMINAR?eventful-September-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at DoubleTree by Hilton San Diego Downtown
1646 Front St, San Diego, CA 92101, USA
San Diego, United States

FDA Scrutiny of Promotion and Advertising Practices 2017

FDA Scrutiny of Promotion and Advertising Practices 2017
Event on 2017-08-24 09:00:00
Course "FDA Scrutiny of Promotion and Advertising Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. In contrast, FDA's Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach. Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it. Bottom line, do you know when you fail to meet FDA's requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customers' mind becomes an unwelcomed nightmare.
In this seminar, you will learn how to navigate FDA's numerous legal options and how to interpret them based on basic legal principles. Applying new guidance documents becomes a new test of the FDA's legal boundaries and enforcement options. The agency is now conducting clinical studies and applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipline may or may not get to the root of what consumers take away as the message.
Congress and the new FDA Commissioner seem more sympathetic to expanding access to medical treatment before all the conclusive evidence for safety and effectiveness is evaluated by the FDA. Valid off-label information may take the lead in that direction.
This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. Operating in a stovepipe environment will not work. You need to understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion practices.

Learning Objective:

• Learn how FDA faces constitutional constraints on enforcement decisions
• Learn about intersecting federal requirements by the Department of Justice, the Federal Trade Commission, the Securities and Exchange Commission and the Consumer Product Safety Commission
• Learn how the FDA interprets advertising and promotion in principle and in fact
• Understand ways that a firm violates FDA requirements
• Evaluate advertising and promotional material based on interactive group hypotheticals
• See how sales and marketing departments play a central role, for better or worse
• Learn how the federal government holds executive management responsible for missteps in promotion and advertising practices.

Who Will Benefit:

• Sales and Marketing executives and managers
• Regulatory Managers
• In-house Legal Counsel and Contract Specialists
• 3rd party consultants
• Venture Capitalists
• Investors
• Business Acquisition Executives
• Owners of New or Developing Firms
• Own label distributors
• International Trade Managers
• Product specification developers

Background

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person's behavior and decision outcomes. The vehicle for communication has evolved dramatically over the past 100 years and continues to evolve at a rate faster than one can anticipate at times. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the legal field playing field involves other federal agencies and departments, and they work in concert with FDA. It has become very complicated and very costly if you knowingly or unknowing walk into a legal snare. This seminar is designed to bring you up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

Agenda:

Day 1 Schedule
8:30 AM – 9:00 AM: Registration
9:00 AM – 10:30 AM
Lecture 1: FDA legal authority
• FDA application of the FD&C Act and implementing regulations
• FTC / mass media
• SEC/False statements
• DOJ / False Claims
• Enforcement authority and options
Cognitive psychology vs. psychoanalytic motivation
10:30 AM – 12:00 PM
Lecture 2: Promotion and Advertising: scope of labeling
• Definitions for "label" and "labeling"
• Hard copy and electronic
• Testimonials
• Blogs
• Sales force
• What is "off-label?"
• Practice of Medicine exemption
• Drugs authority
• Devices
• Dietary supplements
12:00 PM – 1:00 PM Lunch
1:00 PM – 2:30 PM
Lecture 3: Supreme Court / commercial free speech
• Constitutional protection and case law
• Amarin Case: off-label, but true
• Safe harbor
Policy
• FDA organizational responsibility
• FDA Guidance
2:30 PM – 2:45 PM Break
2:45 PM – 4:30 PM
• Fair and balanced disclosure
• Social media
• Direct to Consumer Advertising
Hypothetical Workshop
Day 2 Schedule
9:00 AM – 10:30 AM
Lecture 1:
Direct to consumer advertising vectors
Federal Trade Commission interest (economic vs. safety)
Context and format of messaging
Script versus message
• Target population
• Aspirations
• Emotional factors
10:30 AM – 12:00 PM
Lecture 2: False and misleading information
• Statutory basis (21 U.S.C. 352(a))
• New use
• Comparative claims
• Claims for safety and effectiveness
• Sales for solicitation
12:00 PM – 1:00 PM Lunch
1:00 PM – 2:30 PM
Lecture 3:
Off label use – practices and policy
FDA Warning Letters
2:30 PM – 2:45 PM Break
2:45 PM – 4:30 PM
Lecture 4:
Practice of medicine exemption
Custom Device promotion
(Group Hypothetical)
Corporate management responsibili

Speaker
Casper Uldriks
ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.

Location: Minneapolis, MN Date: August 24th & 25th, 2017 and Time: 9:00 AM to 4:30 PM
Venue: Embassy Suites by Hilton Minneapolis Airport 7901 34th Ave South, Bloomington, MN 55425 USA

Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until July 15, Early Bird Price: ,295.00 From July 16 to August 22, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901100SEMINAR?eventful-August-2017-SEO
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at Embassy Suites by Hilton Minneapolis Airport
7901 34th Ave South, Bloomington, MN 55425
Bloomington, United States

Root Cause Analysis and CAPA using 8-D Problem Solving Method 2017

Root Cause Analysis and CAPA using 8-D Problem Solving Method 2017
Event on 2017-08-24 08:30:00
Course "Root Cause Analysis and CAPA using 8-D Problem Solving Method" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Errors and defects are a problem in virtually every industry. The goal of defect-free/error-free product or service delivery is the aim of every company. However, in order to eliminate defects or errors permanently, you must use a disciplined approach in order to ensure that the problem does not recur. One of the most widely-used tools is the 8 Disciplines (8D) methodology. 8D requires you to identify and fix the problem immediately (put a bandaid on it) while identifying the Root Cause(s), and take steps to address the problem in the short term as well as in the long term (permanent fix).
In this interactive workshop, you'll learn how to apply the many tools used to identify possible causes, determine (with data) which is the true root cause (or causes, as there may be some compounding of problems occurring), and how to fix them – permanently.
8D is used by a wide variety of industries – from service to design, manufacturing, and fulfillment. 8D has been used by sales forces, development teams, hourly personnel, and C suite effectively, and is a technique that is easily mastered.
One of the biggest detractors to using the 8D technique is that it does not always address the issue fully. However, after studying the reasons behind this weakness, I've developed an additional emphasis to minimize risk and maximize success using the 8D framework. This is the only course that teaches this additional emphasis, and I developed this methodology when I was hired by Motorola to eliminate returns for a particular defect (after previous efforts had seen the defect return). I've been teaching this "magic bullet" method ever since.
The course is highly interactive and will require all participants to work through examples in class, allowing you to learn experientially as well as through lecture. Class notes are provided so you can concentrate on what we're talking about vs. taking copious notes.
In this two-day workshop seminar, you'll learn how broad-based this technique is, how it can be easily adapted for a wide variety of industries, and how to participate in, and lead, an 8D team.

Learning Objectives:

Upon completing this course participants should be able to:
• Explain what 8D is and how it is applied
• Understand where 8D is used in the PDCA cycle
• Apply various tools and techniques to describe the problem more accurately
• Understand what is a Root Cause of a problem, vs. what is a symptom of the problem
• Understand which types and severity of problems should initiate a formal Root Cause Analysis (RCA)
• Utilize a Risk Based approach to identifying Root Cause Analysis
• Apply RCA to Context of the Organization and Risk Analysis
• Evaluate effectiveness of proposed Corrective Actions in addressing the Root Cause
• Apply various tools to RCA and 8D
• Understand the difference between short-term/interim solutions and long-term/permanent solutions.
• Participate in an 8D team
• Apply various quality tools to determine long-term solutions
• Lead an 8D team successfully
• How this fits into the Corrective and Preventive Action (CAPA) program
• Determine when to stop collecting data/evidence of effectiveness
• How to use 8D when answering Supplier Corrective Action Requests (SCARs)
• Apply this to your own organization effectively.

Who Will Benefit:

This course is designed for anyone who is participates in addressing Supplier Corrective Actions, internal corrective action programs, or who is tasked for eliminating or minimizing defects as part of a Continual Improvement (CI) program. This includes those that have Quality, Environmental, or Occupational Health/Safety Management Systems responsibilities for making general improvements in their organization's performance, as well as the specialists in various areas who are the subject matter experts. A partial list of personnel who will benefit from the course:
• Senior managers
• Quality professionals
• Environmental professionals
• Occupational Health/Safety (OHS) professionals
• Regulatory professionals
• Production supervisors and managers
• Manufacturing engineers
• Production engineers
• Design engineers
• Process owners
• Supplier engineers
• Customer engineers
• Quality, environmental, and OHS auditors
• QMS, EMS, and OHS Management Representatives

Agenda:

Day 1 Schedule

Lecture 1:
Brief Background and History
• What is 8D
• Who uses 8D / applications in various industries
Lecture 2:
The 8 Disciplines (8D) Overview
• Review of each step
• Learn the common tools to use at each step including
o Is / Is not technique
o 5 whys
o Pareto Diagram
o Fault Tree Analysis
o Value Stream Mapping / Process Flow charts
o Paynter Chart
o Fishbone (Ishikawa / Cause and Effect) Diagram
Lecture 3:
Introduction to Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA)
• Defining the what is, and what is not, RCA
• Discussion on what constitutes a good CAPA
Lecture 4:
Why good Root Cause Analysis is key to good 8D / CAPA
Lecture 5:
Hands-on Exercises – Tools

Day 2 Schedule

Lecture 1:
Refresher/review of Day One – Key Concepts
Lecture 2:
Hands-on Workshop – problem-solving tools (group exercise)
• Review exercise
• Define / apply which tools are best at each step
• Derive the best solution(s) to the problem
Lecture 3:
Hands-on Workshop – 8-D Problem Solving tool (group exercise)
• Work on exercise in teams
• Gather data as needed
• Determine which tools to apply when
• Propose optimum solution based on information at hand
Lecture 4:
Common Mistakes and how to Design around them
• Solutions don't "stick"
• Solution did not solve problem permanently
• Data collection until "the end of time"
• No buy-in from users or management
Lecture 5:
Applying 8D to various problems
• Defect elimination
• Customer satisfaction improvement
• Internal defects / rework elimination
Lecture 6:
Questions
Lecture 7:
Summary

Speaker
Dan O'Leary
Mary McDonald

Mary F. McDonald is a process quality specialist with over 25 years' experience in large industries and small enterprises. Her experience allows her to design unique solutions to difficult problems, synthesizing tools from Lean, engineering, quality, environmental, and health/safety disciplines.
Ms. McDonald is currently the CEO/CTO of the McDonald Consulting Group (McDCG) in Austin, TX. McDCG is a recognized leader in providing process improvement consulting to a wide variety of customers in the healthcare, high technology, service, automotive, aerospace, semiconductor, and manufacturing disciplines. Her clients include Bayer, EDS, the FAA (Federal Aviation Administration), Huawei/HiSilicon, IBM, Motorola/Freescale, the University of Texas, Texas A&M University, and many others.
She holds a Master's in Industrial Administration degree from Union College, Schenectady, NY, and a Bachelor's in Environmental Engineering degree from Worcester Polytechnic Institute, Worcester, MA. An author of several academic pieces, she is the recipient of many industry awards. She also holds numerous professional society memberships and is well-known in these circles.

Location: Minneapolis, MN Date: August 24th & 25th, 2017 and Time: 8:30 AM to 4:30 PM
Venue: Embassy Suites by Hilton Minneapolis Airport 7901 34th Ave South, Bloomington, MN 55425 USA

Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until July 10, Early Bird Price: ,295.00 From july 11 to August 15, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901004SEMINAR?eventful-August-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at Embassy Suites by Hilton Minneapolis Airport
7901 34th Ave South, Bloomington, MN 55425 USA
Bloomington, United States

HIPAA 2017 Under Trump 2017

HIPAA 2017 Under Trump 2017
Event on 2017-08-24 09:00:00
Overview:

The secret is – HIPAA Rules are easy and routine to follow – when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises, and show how to find the right rule with the step-by-step procedures you need when you need them.
Seminar Takeaways
Thorough Understanding of HIPAA Rules
• What they are
• How they work together
• Why and how they were made
• How they are changing and what to expect next
HIPAA Risk Analysis – Risk Management for Your Organization
• A Practical Guided Exercise done in class on your computer to take home
Privacy and Security Rules – Permitted and Required Uses and Disclosures
• What information must be protected
• Administrative, Technical and Physical Safeguards
• Social Media, Texting and Emailing Patients
The inter-connected, inter-dependent relationship of Covered Entities and Business Associates
• Business Associate HIPAA compliance responsibilities
• The importance of Due Diligence and how to do it
• How to avoid making a Business Associate your Agent by mistake
• The chain of responsibility from Covered Entity to Business Associate to Subcontractor Business Associate, etc.
• Business Associate responsibilities for Subcontractor Business Associates
• Breach Notification discovery and reporting by Business Associates and Subcontractor Business Associates
What is – and what is not a Reportable Breach of Unsecured PHI
• Potential Breach Investigation – Breach Exceptions
• Ransomware
• Breach Risk Assessment
• Breach Prevention

Why you should attend:

More than 160 Million Americans have been affected by Breaches of their unsecured Protected Health Information since 2009 when the U. S. Department of Health and Human Services began to keep track. The FBI warned that Medical identity is much more valuable than any other personally identifiable information to identity thieves and the healthcare industry is not prepared to combat this serious, growing threat. Congress passed the HITECH Act in 2009 requiring increased HIPAA enforcement and HIPAA compliance audits. Federal Inspectors General, patient, privacy and consumer advocates demand HIPAA compliance and enforcement.
New strains of ransomware that steal protected health information in addition to locking it up are attacking the health care industry. Threats to health information privacy grow daily. Whether or not the Trump administration eases up on HIPAA Enforcement the healthcare industry must step up, increase its vigilance and HIPAA compliance to prevent breaches, protect patients, protect their own organizations and fight health information thieves.

Who Will Benefit:

Health Care Providers and Business Associates
• HIPAA Compliance Officials
• Risk Manager – Compliance Manager
• Information Systems Manager
• Contract Managers
• Legal Counsel
• Privacy & Security Officials
• Auditors

Agenda:

Day 1 Schedule

Lecture 1:
• President Trump and Secretary Price – How may they affect HIPAA Enforcement?
• HIPAA Overview – HIPAA Compliance Fundamentals
• HIPAA explained in plain language
• 6 Basic HIPAA Compliance Policies
Lecture 2:
• HIPAA Risk Analysis – Risk Management – The basis of your HIPAA Protection and Compliance Program
• Learn by Doing You will do a guided step-by-step HIPAA Risk Analysis – Risk Management of your organization on your tablet/laptop – for you to take with you
Lecture 3:
• Finish HIPAA Risk Analysis – Risk Management
• Consider lessons learned
• How might you improve your HIPAA Compliance Program?
Lecture 4:
• Privacy Rule
• Protected Health Information (PHI)
• Permitted uses and disclosures of PHI
• Social Media

Day 2 Schedule

Lecture 1:
• Security Rule
• Electronic Protected Health Information (EPHI)
• Permitted Uses and Disclosures of EPH
• Security official duties
Lecture 2:
• Business Associates
• Inter-connected HIPAA Compliance for Covered Entities and Business Associates – Agency
• Due Diligence
• Subcontractor Business Associates
• Business Associate Agreement
• Non-BA Confidentiality Agreement
Lecture 3:
• Breach Notification
• Learn by Doing Investigate a Potential Breach
• Do a Breach Risk Assessment
• When you must notify – and when you do not need to notify
• Notifications and Documentation
Lecture 4:
• Install or update your HIPAA Compliance Program
• Workforce training
• How to prepare for HHS Audits or investigations
• Final Questions – Answers – Discussion

Speaker
Paul R. Hales, J.D.
Paul R. Hales, Attorney at Law, LLC

Paul R. Hales received his Juris Doctor degree from Columbia University Law School and is licensed to practice law before the Supreme Court of the United States. He is an expert on HIPAA Privacy, Security, Breach Noti?cation and Enforcement Rules with a national HIPAA consulting practice based in St. Louis. Paul is the author of all content in The HIPAA E-Tool, an Internet-based, Software as a Service product for health care providers and business associates

Location: Tampa, FL Date: August 24th & 25th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Tampa Airport Marriott Tampa International Airport (TPA), 4200 George J Bean Pkwy, Tampa, FL 33607, USA

Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until July 15, Early Bird Price: ,295.00 From July 16 to August 22, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901074SEMINAR?eventful-August-2017-SEO
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at Tampa Airport Marriott
Tampa International Airport (TPA), 4200 George J Bean Pkwy, Tampa, FL 33607, USA
Tampa, United States

Quality Management System ISO 13485- 2017

Quality Management System ISO 13485- 2017
Event on 2017-08-17 09:00:00
Course "Implementing ISO 13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation.
This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns.
Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. The EU is not participating, has published its own version, EN ISO 13485:2016, and will continue with the Notified Body system. However, the EU intends to replace the directives with new regulations resulting in new versions of EN ISO 13485:2016 and EN ISO 14971:2012.
The workshop covers implications in particular regulatory systems including MDASP and its nonconformity grading system.

Why should you attend:

The transition to ISO 13485:2016 can be complicated and, for some companies, the period is short, depending on when the current certificate expires. Start planning and implementing as soon as possible. This workshop provides the knowledge and understanding to update your QMS.

Workshop Objectives:

Participants will learn the major changes in the new version of the standard. In addition, they will understand where the new standard and QSR do not agree. The primary objective is to give participants the understanding needed for an efficient and effective QMS update.

Who Will Benefit:

• Quality managers
• Management Representatives
• Quality engineers
• Quality assurance and quality control
• Regulatory affairs managers
• Regulatory affairs professionals
• R&D managers
• R&D engineers
• Product design and development
• Operations managers
• Production managers and supervisors
• Manufacturing engineers
• Risk managers
• Complaint system team members
• CAPA team members

Agenda:

Day 1 Schedule

Lecture 1:
Overview of ISO 13485:2016
• Summary of the differences between ISO 13485:2003 and ISO 13485:2016
• High level comparison with FDA QSR
Lecture 2:
Regulatory Framework
• Transition period for certificates
• Canada – MDSAP v CMDCAS
• EN ISO 13485:2016 and the MDD
• The new QMS audit findings/nonconformance grading system
• Implications of the EU's Medical Device Regulations
Lecture 3:
Management Responsibility
• Quality Policy and Objectives
• Responsibility and Authority
• Internal Quality Audits
• Management Review
Lecture 4:
Resource Management
• Competence and Training
• Infrastructure
• Work Environment and Contamination Control
Lecture 5:
Design and Development
• Design Planning
• Design Inputs and Design Outputs
• Design Verification and Design Validation
• Design Review
• Design Transfer
• Design Changes
• Design Files

Day 2 Schedule

Lecture 1:
Supplier Management
• Selection
• Purchasing Information
• Written Quality Agreements
• Purchased Product Verification
Lecture 2:
Production Processes
• Production Control
• Installation and Servicing
• Identification and Traceability
• Control of Nonconforming Product
Lecture 3:
Process Validation
• When to Validate
• Validation Requirements
• Software Validation
Lecture 4:
Monitoring and Measuring
• Control of Equipment
• Processes and Products
• Data Analysis
• Complaint Handling
Lecture 5:
Corrective and Preventive Action
• Corrective Action
• Preventive Action

Speaker
Dan O'Leary
President, Ombu Enterprises

Dan O'Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Location: Chicago, IL Date: August 17th & 18th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Four Points by Sheraton Chicago O'Hare 10249 W Irving Park Road, Schiller Park, IL 60176, United States

Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until July 10, Early Bird Price: ,295.00 From july 11 to August 15, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901110SEMINAR?eventful-August-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at Four Points by Sheraton Chicago O’Hare
10249 W Irving Park Road, Schiller Park, IL 60176, United States
Schiller Park, United States

Red Letter Day 2017

Red Letter Day 2017
Event on 2017-08-11 12:30:00
RED LETTER DAY is back for a second year with all new trends about marketing to women. This year, it's a half-day mini conference focused on reaching the Lipstick Economy, the 100 million women who control 85% of all consumer purchases. We have assembled an amazing group of marketing experts again this year.  We'll be talking about important issues with real marketers who can offer real solutions. • How women using social media shape our strategy• Practical solutions to communicating with today’s busy women• Compelling brand stories from vital and relevant brands• Media tactics to cut through the clutter• How to deal with the all important online reviews• New trends and research on women and why they feel misunderstood by marketers Our Awesome Speakers This year we have ten awesome speakers in our jam-packed event.  We'll have great conversations with marketers and then end with cocktails and conversation.  Anne McGraw, Senior Manager, Social Media Marketing, Nissan North AmericaNeil McCormick, Sales and Marketing Manager, Yazoo Brewing CompanyAaron Clifford, Senior Vice President of Marketing, Binary FountainHolly Talbert, AVP Brand Strategy & Development, HCARachel Layton, Marketing Director, A. Marshall Family FoodsMignon Francois, CEO and Founder, The Cupcake CollectionLiz Denning, Owner, Gamma BlastMike King, Producer | Owner, MPKinteractivePaul Hickey, Owner, Data-Driven DesignElizabeth Duffey, Senior Email Specialist, EMMAJamie Dunham, President and Founder, Brand Wise

at City Winery Nashville
609 Lafayette Street
Nashville, United States

Lineament analysis and appropriate sampling and Quality Assurance Quality Control 2017

Lineament analysis and appropriate sampling and Quality Assurance Quality Control 2017
Event on 2017-08-24 09:00:00
Course "Lineament analysis and appropriate sampling and Quality Assurance/Quality Control (QA/QC) procedures to help you find your next mine" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Upon completing this course, participants should:
• Understand the limitations of the current exploration process
• Learn to use lineament and satellite interpretation as a way to define where to concentrate their exploration efforts
• How to implement QA&QC procedures to guarantee the quality of the collected data

Why you should attend:

We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. Even over new areas with limited or nonexistent geological information, we are able to help you concentrate your exploration efforts to keep your budget in the black.
Appropriate sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process to ensure that the best possible confidence in resultant mineral resource and reserve estimates are achieved, as the quality of an estimate is dependent on the quality of the data used.
The Quality Assurance and Quality Control (QA/QC) procedures and protocols are designed to ensure that data collected and created by the company is of a high level of quality and is in compliance with CIM Standards and Guidelines. In practical terms, geological quality control procedures are intended to monitor precision and accuracy of the assay data, as well as possible sample contamination during sample preparation and assaying.
Compliance with the industry-established QA/QC is no longer an option, but a necessity for all the companies to implement, especially those that trade in the markets.
We have implemented a Quality Assurance program for the field sampling procedures which include collection, labeling, and shipping components. Quality Assurance is essentially the management system that operates to ensure credible results. Our Quality Control component of this system is a set of activities intended to control the quality of the data from collection through to analysis. It consists of day-to-day activities such as: the adherence to written protocols; up-to-date and suitable training of personnel; the use of reliable laboratories with excellent QA&QC systems in place, the regular use of Quality Control (QC) samples (blanks, standard samples, and field duplicates); and, diligent record keeping. The prime objective of the field QA program is to maximize accuracy by reducing introduced variability.
If you want to find your next ore body in the most effective way, then this webinar is for you.

Areas Covered in the Session:

• History of the problem, why we need to change the current approach.
• Lineament analysis
• Lineament analysis and satellite interpretation of data
• Physical modeling (3D strain analysis and 3D stress analysis).
• Statistical procedures (Compositional data analysis, correlation analysis, principal component and other methods).
• Defining a QA/QC program, Blanks, duplicates, standards, external controls.
• Procedures and audits
• Rock naming in the field
• Conclusions and recommendations.

Who Will Benefit:

This course is designed for people tasked with developing, maintaining and/or improving environmental monitoring programs for non-sterile manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance specifically related to microbial control of the manufacturing environment. Following personnel will benefit from the course:
• Senior Geologists
• Geochemists
• Exploration Personnel
• Laboratory Personnel
• Managers
• Graduate Students
• Postgraduate Students
• QA&QC Personal

Agenda:

Day 1 Schedule

Lecture 1:
History of the problem, why we need to change the current approach.
Lecture 2:
Lineament analysis
Lecture 3:
Lineament analysis and satellite interpretation of data
Lecture 4:
Physical modeling (3D strain analysis and 3D stress analysis).
Lecture 5:
Statistical procedures (Compositional data analysis, correlation analysis, principal component and other methods).

Day 2 Schedule

Lecture 1:
Defining a QA/QC program, Blanks, duplicates, standards, external controls.
• How to use them
• How to interpret them
Lecture 2:
Procedures and audits
• Laboratories
• Drilling
Lecture 3:
Rock naming in the field.
Lecture 4:
General recommendations, Conclusions and recommendations.
Lecture 5:
Questions and answers

Speaker
Ricardo Valls
President, Valls Geoconsultant

As a professional geologist with thirty years in the mining industry, I have extensive geological, geochemical, and mining experience, managerial skills, and a solid background in research techniques, and training of technical personnel. I am fluent in English, French, Spanish, and Russian. I have been involved in various projects world-wide (Canada, Africa, Russia, Indonesia, the Caribbean and Central and South America). Projects included from regional reconnaissance to local mapping, diamond drilling and RC-drilling programs, open pit and underground mapping and sampling, geochemical sampling and interpretation, and several exploration techniques pertaining to the search for diamonds, PGM, gold, nickel, silver, base metals, industrial minerals, oil & gas, and other magmatic, hydrothermal, porphyritic, VMS and SEDEX ore deposits. Special strengths are related to acquisition of new properties, geochemical and geological studies, management and organization, geomathematical analysis and modelling, compositional data analysis, structural studies, database design, QA&QC studies, exploration studies and writing technical reports. P.Geo. registered in the provinces of Ontario and Quebec.
I have Membership in the Association of Professional Geoscientists of Ontario, the Geological Association of Canada, the Mineralogical Association of Canada, the Association of Exploration Geochemistry, the Prospectors and Developers Association of Canada, the Society of Economist Geologists, and several other North and Central American professional associations.

Location: Cincinnati, OH Date: August 24th & 25th, 2017 and Time: 9:00 AM to 4:30 PM

Venue: Cincinnati Airport Marriott 2395 Progress Drive, Hebron, KY 41048, USA
Price:

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Price: ,295.00 (Seminar Fee for One Delegate)
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at Cincinnati Airport Marriott
2395 Progress Drive, Hebron, KY 41048, USA
Hebron, United States