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Jul 2016


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Avoid Warning Letters in View of the U.S. FDA's Stated Goal - By AtoZ Compliance

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Key Take Away:

Learn how to minimize the chance of receiving an FDA Warning Letter, what to doing during and after an FDA compliance audit to avoid common areas for critical mistakes.


FDA Warning Letters and recent high-profile recalls indicate major cGMP training deficiencies in many companies.

Why Should You Attend:

Targeted cGMP issues. How can a company proactively minimize the chance of receiving a Warning Letter? Areas a company "must review" beforehand. What to doing during an FDA compliance audit training?

What to do immediately after the audit? What to do during the response period. Lessons learned.

Areas Covered In This Webinar:

  • The U.S. FDA's new aggressive implementation plans 
  • Proactive reviews of the applicable U.S. FDA / cGMP guidelines
  • Key areas to focus limited resources

Learning Objectives:

  • FDA Inspectional objectives
  • Common areas for critical mistakes
  • Recent trends and events
  • The compliance audit

Who Will Benefit:

  • Senior Management
  • Project Leaders
  • Regulatory Affairs 
  • Quality Systems Personnel
  • Internal and Supplier Auditor Personnel
  • R&D and Engineering Staff
  • CAPA and P&PC Personnel
  • Speakers Profile:

John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. 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).

For more detail please click on this below link:

Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509

Fax: +1-516-300-1584


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