Conduct of the Tougher U.S. FDA cGMP Inspection

Instructor: John E Lincoln
Product ID: 701491
Training Level: Intermediate to Advanced
  • Duration: 95 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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CD and Ref. material will be shipped within 15 business days

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Fax: +1-650-565-8542


Read Frequently Asked Questions

This cGMP Inspection training Webinar will discuss how the on-site CGMP(Current Good Manufacturing Practices) compliance audit is changing and how a new tougher CGMP audit is being conducted by investigators based on new regulatory climate.

Why You Should Attend:
There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits. This change in focus has a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to recent food, device and drug problems. Congress is involved. This is affecting the Agency's approach to audits and their expectations for companies. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. Recent headlines indicate a public's growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA.

This webinar builds on one previously offered on the new FDA inspection paradigm. It walks participants through a "typical" new, tougher CGMP compliance audit. It will figuratively "look over the shoulder" of an investigator as they walk though a device plant and perform an audit, based on this new regulatory climate.

Areas Covered in the seminar:

  • The changing regulatory climate.
  • Avoid complacency from past "good" FDA audits .
  • Initial contacts and management team meeting.
  • The tour and systems audit.
  • Drilling down.
  • Documentation / records issues.
  • Damage control.

Who will benefit:

This webinar will provide valuable assistance to personnel in all regulated companies responsible for cGMP compliance. This information applies to personnel / companies in the Medical Device, Pharmaceutical, Diagnostic, Biologics and Dietary Supplements fields. The employees who will benefit include:
  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • Engineering
  • All personnel involved in a U.S. FDA-regulated environment

Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o 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 software 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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