Verification vs. Validation – Product Process Software and QMS 2018

Verification vs. Validation – Product Process Software and QMS 2018
Event on 2018-01-22 09:00:00
Course "Verification vs. Validation – Product Process Software and QMS" 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 review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: Understand Verification and Validation, differences and how they work together;Discuss recent regulatory expectations;Know how to document a "risk-based" rationale, and use it in a resource-constrained environment;Determine key "milestones" and "tasks" in a project;Locate and document key subject "inputs";Compile "generic" Master and Individual Validation Plans;Learn the key element of a Product V&V File/Protocol;Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;Get a grasp of basic Test Case construction;Understand sample sizes and their justification;Learn the key elements of Software V&V expected by the FDA and how to document;Deal with hardware and software vendors, sales and marketingConsider a field-tested software V&V documentation "model";See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11. Who will benefit: This workshop will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and V&V activities / plan(s). This information addresses Medical Devices, Pharmaceutical, Diagnostic, and Biologics requirements and implementation. The employees who will benefit include: Senior and middle management and staffRegulatory AffairsQuality Assurance or Quality Control ProfessionalsQA/QCIT/ISR&DProduction ManagementManufacturing EngineersProcess EngineersSoftware EngineersProject ManagersHardware and software vendors, sales and marketingAny professional tasked with V&V responsibilities Agenda: Day 1 Schedule Lecture 1: Master Validation Planning and the Master Validation Plan(s) Lecture 2: Product, Process / Equipment Hardware V&V Lecture 3: Product / Device V&V Lecture 4: Software V&V Lecture 5: Quality Management System / 21 CFR Part 11 V&V Lecture 6: Summary of morning discussion Lecture 7: Group activity on the MVPs Lecture 8: Review of group activity and Q&A Day 2 Schedule Lecture 1: Software V&V documentation "model" Lecture 2: Software V&V protocols – "black box", "white box" Lecture 3: Electronic Records and Electronic Signatures (Part 11) Lecture 4: Summary of morning discussion Lecture 5: Group activity on 1) hardware / equipment, and 2) software V&V protocols Lecture 6: Review of group activity and Q&A Lecture 7: Course summary discussion Lecture 8: Summary of morning discussion Lecture 9: Group activity on the MVPs Lecture 10: Review of group activity and Q&A Speaker John E Lincoln Consultant, Medical device and Regulatory affairs, John E Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles and workshops worldwide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt. Location: St. George UT Date: January 22nd & 23rd, 2018 and Time: 9:00 AM to 6:00 PM Venue: Hilton Garden Inn St. George 1731 South Convention Center Drive, Saint George, Utah, 84790, USA Price: Price: ,295.00 (Seminar Fee for One Delegate) Register now and save 0. (Early Bird) Until January 01, Early Bird Price: ,295.00 From December 31 to January 20, Regular Price: ,495.00 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%)* 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=901450SEMINAR?ticketleap-January-2018-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 Seminar Fee for One Delegate – 95.00

at The Hilton Garden Inn
1731S.ConventionCenterDrive
Saint George, United States

Restaurant Clicks First Annual Holiday Party

Restaurant Clicks First Annual Holiday Party
Event on 2017-12-08 20:00:00
Restaurant owners of Philadelphia, Restaurant Clicks invites you to their first annual holiday party. Join us for a night of celebration on Friday December 8th at Fine Palate located in Center City. We will recognize some of the best restaurants in the city of brotherly love while partaking in some holiday festivities. Admission is free to enter with an RSVP and will include one free drink ticket. Sign up today: restaurantclicks.com

About Restaurant Clicks:

Digital marketing agency specializing in lead generation, SEO, website design and social media marketing for restaurants and hospitality businesses. We are former restaurant owners and marketing geeks who want to help the restaurants succeed with quality marketing. This Restaurant Clicks marketing agency is founded on over 15 years of successes and failures in the restaurant industry.

at Fine Palate
231 S. 15th Street
Philadelphia, United States

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

HOW TO BUILD & MANAGE YOUR OWN WEBSITE (WORDPRESS) – DERBY

HOW TO BUILD & MANAGE YOUR OWN WEBSITE (WORDPRESS) – DERBY
Event on 2017-10-28 11:30:00
What do you do when you want to find a local restaurant, hairdresser, accountant, event or product supplier?  You Google it of course; and so do your customers.  Whichever businesses come up in their search results get their attention – and their custom. In today’s world, if you’re not online, you’re completely invisible and you are missing out on income – big time.    Websites show your customers what you do, what you have on offer and what they can buy from you; they generate trust and credibility as well as build your email list and provide you with global exposure.  But, for those new to ‘going online’, this process can seem overwhelming, confusing and expensive.    In this workshop, you will see how simple it really is and create your very own basic website using the popular WordPress platform.  In just 3 hours, you will learn all of the basics of building, designing and editing your own website and will practice on a REAL practice website in your company name.   Due to the hands-on nature of this workshop, there are only 15 places available.  If there is an over subscription, we will hold another workshop.   WHAT YOU WILL LEARN: How To Choose and Buy Your Own Domain Name How To Build and Set-Up Your WordPress Website How To Edit Your Website How To Make a Blog   WORKSHOP BONUS You will have a template website prepared for you and provided to you on the day as part of your workshop fee.  If you decide that you’d like to keep your website and have it professionally designed, we have a very special deal available for workshop attendees where you can get a ,000 website development package for just ,200!   The special deal website offer includes: 5 Page Website (Home, About, Products/Service, Blog, Contact) Hosting for 6 months Mobile Responsive Video Training Included SEO Plugins Premium Theme Developer Licensing Included.  This included access to Beaver Builder, PowerPack Addons, Ultimate Addons, Beaver Themer, Gravity Form and any other plugins that we may purchase under developer license. If they wish to change in the future all they'd need to do is purchase a regular license for each of the tools they wish to use. Basic help with refining text for site 30 min support time per month premium hosting included software updates uptime and security monitoring performance optimisation detailed monthly report daily site backups access to video training

at Derby

Derby, Australia

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