Setting Up and Running a Tougher Supplier Audit Program
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The last few years have seen the U.S. FDA come under increasing negative public scrutiny.
High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based.
Most Warning Letters will not have an initial judicial review, resulting in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. A key area gaining attention is a company’s suppliers, for both services and products / components. Why needed? FDA expectations? How are successful companies meeting this challenge. Tools that need to be put in place or enhanced. Getting supplier buy-in. Coping with "rogue" suppliers.
Areas Covered in the Session:
Who Will Benefit:
- Regulatory "Hot Buttons"
- Classify suppliers
- Supplier requirements by "classification"
- The site audit
- Types of remote audits
- Maintaining the relationship
- Senior Management, Project Leaders, Internal / External Consultants
- Mid-level management and supervisory personnel
- Corporate and site coordinators
- Regulatory Affairs
- Quality systems personnel / QAE
- R&D and engineering staff
- Purchasing personnel
- New product development personnel
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.