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 success measurements. 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 Should You 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.
Course Content
- 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
- Preparation for FDA Inspections
- What to immediately do after notification of the inspection
- Immediate, full, and sequential inspection responses to the Agency
Course Provider
John E. Lincoln,
Principal Consultant ,
J. E. Lincoln and Associates LLCJohn E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years’ experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.
He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process/ product/ equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA.
Who Should Attend
- Senior Management
- Regulatory Affairs
- Quality Assurance
- Production
- Engineering
- All Personnel Involved in a U.S. FDA-Regulated Environment
