Meeting Annual U.S. FDA cGMP Training Requirements

John E Lincoln
John E Lincoln
90 Minutes
Product Id:
6 months

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Price Details
$162 Recorded
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There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.

The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and recent public concern over insufficient oversight of new product introductions (and grandfathered product) by means of the 510(k) system. Business continues to "shoot itself in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. There will be no return to the past. Rather than be caught unprepared, proactively address these trends, and start to address areas of known deficiencies through a proactive training program. We will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate. We will also discuss proven methods to address such training needs.

Why you should attend: The FDA says it's getting tougher. Recent audits and other enforcement actions indicate that's true. The past ways of doing things is not acceptable. The Agency continues to use high-profile cases to drive compliance to smaller companies and suppliers. Recent events in regulated industries indicate a public's growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA. "Business as usual" is unacceptable. Recently several once 'model' companies have received multi-million dollar fines, with one facing criminal charges. Don't let you or your company be caught of guard by these major shifts in emphasis. Modify your internal cGMP compliance training to get 'in sync' with the FDA's shift in focus. Refine your training to address areas of known deficiencies and areas of special FDA concern. Use such to increase productivity. Start immediately.

Areas Covered in the Session:

  • Focus on key cGMP issues
  • Avoid complacency from past "good" FDA / ISO compliance
  • Developing the Annual Lesson Plan(s)
  • The major 21 CFR issues in 111, 210 / 211, and 820
  • Defect recognition
  • How to address known problem areas during cGMP training
  • Stop unauthorized changes -- Prove 'in control'
  • Monitor and maintain 'the edge'

Who Will Benefit:
  • Senior management in Drugs, Devices, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants; others tasked with project leadership responsibilities

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.

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