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Who should attend Avoid Warning Letters in View of the U.S. FDA's Stated Goal - By AtoZ Compliance
Senior Management, Project Leaders, Regulatory Affairs, Quality Systems Personnel, Internal and Supplier Auditor Personnel, R&D and Engineering Staff, CAPA and P&PC Personnel
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Seminar Summary:

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. (see full course description)

 
 
 

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Training Course Syllabus:


Avoid Warning Letters in View of the U.S. FDA's Stated Goal

Overview

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, 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).

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. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

Seminar Summary:

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. (see full course description)

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