Change Control - The Achilles Heel of cGMP Compliance

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

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Price Details
$190 Recorded
$390 Corporate Recorded
Price Detail Options

The last few years have seen an increase in product recalls. For this and other reasons, 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 and subjected to greater scrutiny. Failure to comply will result in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. A key area for maintaining cGMP compliance is Change Control. Yet it often is a company’s weakest link in compliance. Why so? FDA expectations? How are successful companies meeting this challenge. Tools that need to be put in place or enhanced. Getting personnel buy-in. Getting senior management buy-in. Supplier buy-in.

Areas Covered in the Session:

  • Change Control - what it is; what it is not
  • Areas impacted by Change Control
  • Regulatory / FDA 483 "Hot Buttons"
  • Design control
  • Document Control
  • Identifying changes
  • Preventing negative changes
  • Maintain a 'state of control'
  • Business needs and obtaining 'bur-in'

Who Will Benefit:
  • Senior management, project leaders, internal / external consultants
  • Mid-level management and supervisory personnel
  • Corporate and site coordinators
  • Regulatory affairs
  • Quality systems personnel / QAE
  • Document Control
  • R&D and engineering staff
  • Purchasing personnel
  • New product development personnel

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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