Past event: Virtual Seminar on Inspection and Audit Readiness Training for Medical Device Manufacturers

6-Hour Virtual Seminar

There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years.

This change in focus has a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to recent food, device, drug, vacine and infant formula shortage problems. This affects the Agency's approach to audits and their expectations for companies, with emphasis on the key CGMP areas under QSIT. This course focuses on identifying FDA inspection criteria, resources (including key standard operating procedures such as CP 7382.845) and practices used to plan, conduct, and assess inspections of medical device manufacturers. It walks participants through a "typical" new, tougher CGMP compliance audit. It will figuratively "look over the shoulder" of an investigator as they walk though a device plant and perform an audit, based on the always changing regulatory climate.

Why you should attend

Recent US FDA inspections indicate the past ways of doing things will no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. See how the on-site CGMP compliance audit is changing and the FDA focus is shifting. Recognizing what to expect during an FDA inspection enables a medical device manufacturer to effectively prepare for the inspection. This webinar will focus on how to prepare domestic and foreign medical device manufacturers selling to the U.S. to recognize and prepare for FDA pre- and post-market inspections.

Who Will Benefit

  • Senior Management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • Engineering
  • All Personnel Involved in a U.S. FDA-Regulated Environment
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.

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Time: 08:00 AM PDT | 11:00 AM EDT

  • Identify key requirements of the FDA’s Quality System (21 CFR Part 820)
  • Key similarities and differences between 21 CFR Part 820, ISO 13485:2016, and the tougher FDA positions
  • The key focus of FDA’s Quality System Inspection Technique (QSIT) - 15 to 7 to 4
  • A typical FDA CGMP inspection sequence
  • Documentation / records issues
  • Design Control / Design and Development Planning
  • Virtual Inspections / Audits
  • Preparationi for FDA Inspections
  • What to immediately do after notification of the inspecction
  • Immediate, full, and sequential inspection responses to the Agency


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Event details
Organizer : Global Compliance Panel
Event type : Training Course
Reference : ASDE-24397