Meet The tougher U.S. FDA Cgmps

John E. Lincoln

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Tougher FDA CGMP Compliance Audits and enforcement require more effort from industry.
This webinar will examine recent statements by and evidence of the Agency becoming tougher in its expectations for and audits of the regulated medical products industries and their compliance to the cGMPs.  

It will examine how these goals of the Agency have translated into action over the past several years:  The changing focus of QSIT re: medical devices, and ICH Q8, Q9, and Q10 re: pharmaceuticals;  Multi-site company operations, and major changes in supply chain requirements;  Increased validation expectations;  Trends evident in 483 observations,  Warning Letters, and recent major industry failures;  Emphasis on proving a company is "in control" to an investigator's satisfaction;  the negative role of "entropy", and proactive and reactive Warning Letter avoidance techniques.

Course Objective

The last few years have seen several major "names" in drugs and devices stumble over cGMP issues, resulting in multi-million dollar fines, recalls, lawsuits, and even possible criminal prosecution beyond the corporate "veil".  This indicates an on-going, major shift in the emphasis of the U.S. FDA cGMP compliance expectations and resulting audits, also affecting clinical trial expectations, product submissions and company response requirements.  

This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success.  The major failures of key industry "players" in  pharmaceuticals, devices, as well as events in unrelated industries have caused the Agency to "get tougher on compliance / enforcement".   The cGMP compliance audit,  validations, 510(k) submissions / data, "better science", lifecycles, closed-loop CAPA, outsourcing / globalization and supply chain / control issues, and senior management, are all under more intense scrutiny.

Course Outline

  • U.S FDA Changes in Emphasis and Coming Trends Regarding CGMP Compliance
  • Core Expectations
  • QSIT and Q10 Focus;  and Q8 and Q9 "Lessons"   
  • High Risk Areas
  • The Supply Chain
  • Validation -- New Directions
  • The Multi-Site Challenge 
  • What Constitutes "Proof"
  • Addressing the On-site Audit, the 483s, the Remediation / Responses

Target Audience

  • Management staff
  • operators in Pharma, Devices, 
  • Dietary Supplements
  • Biologics -- Life Science Industries

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: John E. Lincoln,

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 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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