Avoid Warning Letters in View of the U.S. FDA's Stated Goal
More Trainings by this Expert
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
Targeted cGMP issues. Â How can a company proactively minimize the chance of receiving a Warning Letter? A Areas a company "must review" beforehand. Â What to doing during an FDA compliance audit. Â What to do immediately after the audit.Â What to do during the response period. Â Lessons learned.
Areas Covered in the Session:
Who Will Benefit:
- The U.S. FDA's new aggressive implementation plans
- Proactive reviews of the applicable U.S. FDA / cGMP requirements
- Key areas to focus limited resources
- FDA Inspectional Objectives
- Common areas for critical mistakes
- Recent trends and events
- The compliance audit
- Senior Management, Project Leaders
- Regulatory Affairs
- Quality Systems Personnel
- Internal and Supplier Auditor Personnel
- R&D and Engineering Staff
- CAPA and P&PC personnel desiring to optimize systems and responses in harmony with the U.S. FDA's quality management systems / cGMP expectations.
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.