Inspection and Audit Readiness Training for Medical Device Manufacturers

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.

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.

Areas Covered in the Webinar:

• Identify key requirements of the FDA’s Quality System (21 CFR Part 820)
• Key similarities and differences between 21 CFR Part 820, ISO 13486:2016, 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
• Preparationi for FDA Inspections
• What to immediately do after notification of the inspecction.
• Immediate, full, and sequential inspection responses to the Agency

Who Will Benefit:

This webinar will provide valuable assistance to personnel in all regulated companies responsible for cGMP compliance. This information applies to personnel / companies in the Medical Device, Pharmaceutical, Diagnostic, Biologics and Dietary Supplements fields. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• Engineering
• All personnel involved in a U.S. FDA-regulated environment.

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John 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 software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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