4-Hour Virtual Seminar

4-Hour Virtual Seminar on Combination Product Device Supplier Management Training

Product Id : 12343
John E Lincoln

Price Details +

$345.00 Live
$545.00 Corporate Live
$395.00 Recorded
$745.00 Corporate Recorded
Combo Offers
Live + Recorded
$592.00   $740.   (20% Off)
Corporate (Live + Recorded)
$1,032.00   $1290.   (20% Off)

Refund Policy

Live: One Dial-in One Attendee

Corporate Live: Any number of participants

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Overview

There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance.

The FDA has implemented major global initiatives.  Companies are required to tightly manage their entire supply chain.  The infrastructure behind the COA / COC is being challenged. Such changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.  The Agency is reacting to increasing negative publicity due to major publicized product failures / recalls / and notable recent product shortages, leading to public concern over insufficient oversight of the entire medical product supply chain, including global outsourcing.  Of both raw materials, components, as well as services.  Combination product add further complexity. "Better science" requirement impacts suppliers as well.  All this is affecting the Agency's approach to inspectioina / audits and their expectations for companies. These areas of change will be evaluated to see how to better prepare for and  address supplier chain management and vendor audits.

Why you should attend

Recent FDA statements and actions indicate the past ways of managing a company's supply chain / outsourcing are not acceptable.  The U.S. FDA has opened eleven of it's own branches in Mainland China, India, and other major areas of the world to train their local counterparts and to better address and audit regulatory compliance of suppliers of medical products and components destined for the U.S. CGMP compliance cannot be passed on to suppliers.  Suppliers thenselves must meet specific CGMP requirements.  Proof for "better science" is also a new expectation and is already having its effect on COAs and COCs. Combination products serve to compound the problems. Don't be caught of guard by these major shifts in emphasis.  Refine supplier management and audits to match the growing  FDA requirements.

Who Will Benefit

  • R&D
  • Regulatory Affairs
  • Quality Assurance
  • Purchasing
  • Production
  • Engineering
  • All personnel involved in a U.S. FDA-regulated Environment

Agenda

  • The Globalization of the Supply Chain and What That Means
  • Combination products and added supplier complexity
  • Avoid complacency from past "good" FDA / ISO audits 
  • Supplier Trending and Ranking Models 
  • Mandated Supplier Controls; Change Controls
  • COAs / COCs
  • Consequences of the "death" of JIT
  • The Tiered Risk-Based Audit Approach

Speaker Profile


John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, 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 described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.