Malaysia eCommerce Expo (ME EXPO) 2017

Malaysia eCommerce Expo (ME EXPO) 2017
Event on 2017-11-22 09:00:00
MALAYSIA FIRST B2B E-COMMERCE TRADE SHOW AND CONFERENCE
The renowned Malaysia eCommerce Expo (ME EXPO) 2017 will returning on this coming 22th-24th to offer local and international trade buyers an opportunity to implement offline to online (O2O) strategy and changing the traditional business culture. E-commerce industry player and public are welcome to visit and attend this inspiring trade show and conference, with an exhibition hall featuring 3190 square meters. Discover web-hosting, payment gateway, fulfilment, digital marketing, E-market place and P.0.S system only at Malaysia eCommerce Expo 2017.

Fair Highlights:
1) Inspiring E-commerce Conference
E-commerce conferences inspire you to challenge what you’re currently doing, test fresh approaches, take on new roles, and form new partnerships. They can take you outside your comfort zone and encourage you to look at your business from a different perspective. Explore the new E-commerce tools and strategies, network with leading industry experts, and become all-around savvier businessperson.

2) Business Matching Services
The Organizer is offering this value-added service which serve as an efficiency sourcing platform for trade buyers to maximize and implement offline to online (O2O) strategy in your business prospect as to change the traditional business culture to drive online strategy. This program enables industry players to source from international vendors and present appointment to meet up at ME EXPO 2017.

Exhibit Profile:
Cross Border Trade, eCommerce Platfrom, Website Implementation, Internet Marketing, MCommerce, Logistics, Media & Social Media, Innovation Incubation & Display, Payment Gateway, Internet Security, Product Sourcing, Internet Service provider, P.O.S system, International pavilion, Fintech

Visitor Profile:
Corporate company, Individual online seller, Whoesaler, Importer & Exporter, Service provider, Manufacturer, Media Agencies, Social Media, Financial Industries
Pre-Register today at http://www.meexpo.com.my/ to receive regular E-commerce industry updates!

at Malaysia International Exhibition & Convention Centre (MIECC)
Jalan Sultan Haji Ahmad Shah
Kuala Lumpur, Malaysia

Why you Should be Worried about HIPAA 2017

Why you Should be Worried about HIPAA 2017
Event on 2017-12-07 09:00:00
Overview:

This seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits or (even worse) litigation occurs against your organization under state laws of negligence.
It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.
The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA – I want to add clarity for compliance officers
I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.
I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).
In addition, this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures.
Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required.

Why you should attend:

There are major changes to HIPAA set forth by the Federal government whereby patients can receive remedies for HIPAA violations and business associates (i.e. law firms) must now comply directly with HIPAA.
Omnibus has changed the HIPAA landscape for good!
State laws are now in place increasing liability for patient remedies!
THESE DAYS THE TRIAL ATTORNEYS ARE MORE DANGEROUS THAN THE FEDERAL GOVERNMENT!!
This once rarely enforced law has changed and you need to know what's going on!
Protect your practice or business!
Why are the Feds enforcing after all these years?
We will be discussing some of the changes taking place in Washington with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books.
I will also thoroughly go through multiple litigated cases I have been a part of involving patients suing for HIPAA violations – THIS IS A MUST TO UNDERSTAND!!
Changes affecting law firms dealing with protected health information
I will also be discussing factors might cause an unwanted visit or letter from the Office of Civil Rights and how to prepare for the audit and deal with the Feds.

Areas Covered in the Session:

• History of HIPAA
• HITECH
• HIPAA Omnibus Rule
• How to perform a HIPAA Security Risk Assessment
• What is involved in a Federal audit and how is it conducted
• Risk factors for a federal audit
• EHR and HIPAA
• Business Continuity/Disaster Recovery Planning
• Business Associates and HIPAA
• In depth discussions on IT down to the nuts and bolts
• BYOD
• Risk factors that can cause an audit (low hanging fruit)
• New rules which grant states ability to sue citing HIPAA on behalf of a patient
• New funding measures
• …much, much more.

Who Will Benefit:

• Practice Managers
• Compliance Officers, and any Business Associates Privy to Private Health Information and Under the Auspices of this Law.

Agenda:

Day 1 Schedule

Lecture 1: HIPAA -History
Lecture 2: HIPAA Privacy Rule vs HIPAA Security Rule
Lecture 3: HITECH Act
Lecture 4: Information Technology
Lecture 5: Breach Notification Rule
Lecture 6: Omnibus Rule
Lecture 7:Business Associates
Lecture 8: Current Court Cases (precedence)
Lecture 9: Paper Based PHI Concerns
Lecture 10: Disaster Recovery Concerns (Paper)
Lecture 11: Psych and Infectious Disease

Day 2 Schedule

Lecture 1: Choosing a HIPAA Consultant
Lecture 2: Choosing an IT Group
Lecture 3: Disaster Recovery Concerns (Electronic)
Lecture 4: Physical Setup
Lecture 5: Overseas Outsourcing
Lecture 6: BYOD
Lecture 7: Texting and Emailing
Lecture 8: What the Feds are Looking For (low hanging fruit)
Lecture 9: What are Factors That Can Get Your Practice Audited
Lecture 10: State Laws and Patient Ability to Sue
Lecture 11: How to Conduct a Risk Assessment
Lecture 12: How to Write Policies and Procedures

Speaker
Brian L Tuttle
Sr Compliance Consultant & IT Manager, InGauge Healthcare Solutions

Brian L Tuttle, CPHIT, CHP, CHA, CBRA, CISSP, CCNA
Brian Tuttle is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified HIPAA Administrator (CHA), Certified Business Resilience Auditor (CBRA), Certified Information Systems Security Professional (CISSP) with over 17 years' experience in Health IT and Compliance Consulting.
With vast experience in health IT systems (i.e. practice management, EHR systems, imaging, transcription, medical messaging, etc.) as well as over 17 years' experience in standard Health IT with multiple certifications and hands-on knowledge, Brian serves as compliance consultant and has conducted onsite and remote risk assessments for over 1000 medical practices, hospitals, health departments, insurance plans, and business associates throughout the United States.
In addition, Mr Tuttle has served in multiple litigated court cases serving as an expert witness offering input related to best practices and requirements for securing and providing patient access to protected health information. Mr. Tuttle has also worked directly with the Office of Civil Rights (OCR) both in defending covered entities and business associates as well as being asked by the Federal government to audit covered entities and business associates on behalf of the OCR.
Almost all of Brian's clients are earned by referral with little or no advertising.
Brian is well known and highly regarded in medical circles throughout the United States for his quality work and down home southern charm.
Mr. Tuttle has a Master's Degree in Health Sciences from Georgia State University.

Location: Orlando, FL Date: December 7th & 8th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Courtyard Orlando Airport 7155 North Frontage Road – Orlando, Florida 32812 USA

Price:
Price: ,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*
Register for 10 attendees Price: ,122.00 ,950.00 You Save: ,828.00 (45%)*
Register now and save 0. (Early Bird)
Until October 20, Early Bird Price: ,295.00 From October 21 to December 05, Regular Price: ,495.00
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=901048SEMINAR?eventful-December-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 Courtyard Orlando Airport
7155 North Frontage Road – Orlando, Florida 32812 USA
Orlando, United States

HIPAA Privacy, Security and Breach Notification Compliance 2017

HIPAA Privacy, Security and Breach Notification Compliance 2017
Event on 2017-11-30 09:00:00
Overview:

This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates.
The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate.
Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.

Who Will Benefit:

• Information Security Officers
• Risk Managers
• Compliance Officers
• Privacy Officers
• Health Information Managers
• Information Technology Managers
• Medical Office Managers
• Chief Financial Officers
• Systems Managers
• Legal Counsel
• Operations Directors

Agenda:
Day 1 Schedule

Day one sets the stage with an overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule
Lecture 1:
Overview of HIPAA Regulations
• The Origins and Purposes of HIPAA
• Privacy Rule History and Objectives
• Security Rule History and Objectives
• Breach Notification Requirements, Benefits, and Results
Lecture 2:
HIPAA Privacy Rule Principles, Policies and Procedures
• Patient Rights under HIPAA
• Limitations on Uses and Disclosures
• Required Policies and Procedures
• Training and Documentation Requirements
Lecture 3:
Recent and Proposed Changes to the HIPAA Rules
• New Penalty Structure
• New HIPAA Audit Program
• New Patient Rights
• New Obligations for Business Associates
Lecture 4:
HIPAA Security Rule Principles
• General Rules and Flexibility Provisions
• The Role of Risk Analysis
• Security Safeguards
• Training and Documentation

Day 2 Schedule

Day two begins with a detailed examination of HIPAA Security Rule requirements and what must be done to survive audits by the US Department of Health and Human Services, including an examination of how risk analysis can be used to drive compliance by the systematic examination of information flows and mitigation of risks discovered, and an exploration of the official HHS HIPAA Audit Protocol, including how to use the protocol to help manage your compliance work and its documentation. Finally, the day concludes with a session on the essential activities of documenting policies, procedures, and activities, training staff and managers in the issues and policies they need to know about, and examining compliance readiness through drills and self-audits.
Lecture 1:
HIPAA Security Policies and Procedures and Audits
• HIPAA Security Policy Framework
• Sample Security Policy Content
• Recommended Level of Detail for Policies and Procedures
• The New HIPAA Compliance Audit Protocol
Lecture 2:
Risk Analysis for Security and Meaningful Use
• Principles of Risk Analysis for Information Security
• Information Security Management Process
• Risk Analysis Methods
• Risk Analysis Example
Lecture 3:
Risk Mitigation and Compliance Remediation
• Typical Security Risks
• Social Media, Texting, e-mail, and Privacy
• Dealing with Portable Devices and Remote Access
• Compliance Planning
Lecture 4:
Documentation, Training, Drills and Self-Audits
• How to Organize and Use Documentation to Your Advantage
• Training Methods and Compliance Improvement
• Conducting Drills in Incident Response
• Using the HIPAA Audit Protocol for Documentation and Self-Auditing

Speaker
Jim Sheldon Dean
Director of Compliance Services, Lewis Creek Systems, LLC

Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a wide variety of health care entities.
Sheldon-Dean serves on the HIMSS Information Systems Security Workgroup, has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup, and is a recipient of the WEDI 2011 Award of Merit. He is a frequent speaker regarding HIPAA and information privacy and security compliance issues at seminars and conferences, including speaking engagements at numerous regional and national healthcare association conferences and conventions and the annual NIST/OCR HIPAA Security Conference in Washington, D.C.
Sheldon-Dean has more than 30 years of experience in policy analysis and implementation, business process analysis, information systems and software development. His experience includes leading the development of health care related Web sites; award-winning, best-selling commercial utility software; and mission-critical, fault-tolerant communications satellite control systems. In addition, he has eight years of experience doing hands-on medical work as a Vermont certified volunteer emergency medical technician. Sheldon-Dean received his B.S. degree, summa cum laude, from the University of Vermont and his master's degree from the Massachusetts Institute of Technology.

Location: Chicago, IL Date: November 30th & December 1st, 2017 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON, Chicago, IL

Price:

Price: ,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*
Register now and save 0. (Early Bird)
Until October 20, Early Bird Price: ,295.00 From October 21 to November 28, Regular Price: ,495.00
Register for 10 attendees Price: ,122.00 ,950.00 You Save: ,828.00 (45%)*

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=901357SEMINAR?eventful-November-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 Chicago, IL
Chicago, IL
Chicago, United States

GMP and Regulatory Expectations for Early IND Products 2017

GMP and Regulatory Expectations for Early IND Products 2017
Event on 2017-11-13 09:00:00
Course "GMP and Regulatory Expectations for Early IND Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

Why should you attend:

Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have modified the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time some of the things that may appear to have changed, have not, and the pharmaceutical worker should be aware of this.

Who will benefit:

• Directors, Managers, Supervisors, and lead workers in Regulatory Affairs, Quality Assurance and Quality Control
• Workers who will prepare GMP documents for early phase products as well as those who will review these documents
• Regulatory affairs workers who will need to deal with submissions covering early phase products

Agenda:
Day 1 Schedule

Lecture 1:
Very Early Stages
• The need for documentation of matters that will affect downstream work.
• The effects of ICH Q8
o Impact on R & D activities
o Risk analysis and design control at this stage.
Lecture 2:
GLP requirements
• Animal studies
o Toxicology and pharmacokinetics.
• Estimating the Maximum Safe Starting Dose
o A review of the guidance document.
Lecture 3:
Early Pre-IND Studies
• Understanding exploratory Studies
o Definitions and the IND that will be withdrawn.
• Orphan Drugs
• Drugs studied under the Animal Rule
o What they are and how to conduct the studies.
Lecture 4:
Meetings and Preparing for the IND
• Information required for the Phase 1 IND
o The CMC requirements that will be needed.
• Pre-IND Meetings with FDA

Day 2 Schedule

Lecture 1:
GMPs for Phase 1 IND products
• The scope of the guidance document
• The second guidance document covering the GMPs.
Lecture 2:
GMPs for Phase 1 continued
• A presentation covering what GMPs are required at this stage.
• What has been omitted from the GMPs for Phase 1.
Lecture 3:
Requirements for Phase 2 INDs
• The full GMPs resume, but do they?
• Phase 2 studies and the transition to full GMPs.
• CMC requirements.
Lecture 4:
Preparing for IND Meetings
• Phase 1 meetings
• Pre-phase 2 meetings
• Phase 2 meetings

Speaker
Dr. Steven Kuwahara
Founder & Principal, GXP Biotechnology, LLC

Dr. Steven Kuwahara, Ph.D. is the Founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.

Location: Taipei, Taiwan Date: November 13th & 14th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON , Taipei, Taiwan
Price:

Price: 5.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: ,685.00 ,475.00 You Save: ,790.00 (40%)*
Register now and save 0. (Early Bird)
Until October 05, Early Bird Price: 5.00 From October 06 to November 11, Regular Price: ,095.00
Register for 10 attendees Price: ,922.00 ,950.00 You Save: ,028.00 (45%)*

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=901321SEMINAR?eventful-November-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 Taipei, Taiwan
Taipei, Taiwan
, Taiwan

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:

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