The Tougher U.S. FDA - One Year Later

Instructor: John E Lincoln
Product ID: 701759
  • Duration: 86 min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

This FDA compliance webinar will evaluate the FDA expectations in the near term and further out in the future and how it will boil down to new regulatory climate.

Why Should You Attend:

The major shift in the emphasis of U.S. FDA to a "tougher" regulatory / CGMPs climate affects all regulated companies. This change in focus has a major impact on individual company compliance objectives, efforts and measurements of success. What has the industry seen after one year of this changed emphasis? How has the changes translated themselves into actions? Based on the last year, what are reasonable expectations for the near term, and further out in the future. Will these changes ever revert back? We will evaluate the chief areas of these FDA regulatory / CGMP compliance changes or new emphasis to see how this translates into future FDA expectations and how such actual and anticipated changes are resulting in a new regulatory climate.

Areas Covered in the Seminar:

  • Stated expectations and the one-year result.
  • Targets.
  • Avoid complacency from past "good" FDA actions.
  • Avoid complacency from just completed "good" ISO feedback.
  • FDA's desired responses from industry.
  • How to respond now -- where to shift focus first.
  • Where to direct scarce resources.
  • Anticipated future directions.
  • Maintain 'the edge'.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA's CGMP audit "paradigm". Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance. This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceuticals and Biologics fields. The employees who will benefit include:

  • Senior management
  • Regulatory affairs
  • Quality Assurance / QAE
  • Production
  • R&D and Engineering

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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 so+E6ftware 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 published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.

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