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Meet the Tougher U.S. FDA CGMPs

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Date: 03-Jun-13 to 03-Jun-13
Location: Online Event / California City / California / United States
Category: Food & Beverages Healthcare & Pharmaceuticals Conferences & Trade Fairs

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.

Visitors

This training will benefit personnel/ companies in the pharmaceutical, medical device, diagnostic, nutraceuticals and biologics fields. The employees who will benefit include:
Senior management
Regulatory Affairs
Quality Assurance
Production
Engineering
Documentation
Internal Audit
All personnel involved in a U.S. FDA-regulated environment, especially those involved in regulatory compliance, CGMP training and auditing, and the production and documentation of regulated medical products.

Exhibitors

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years experience in U.S. FDA-regulated industries, 17 as a full-time 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). 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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