Avoid Warning Letters in View of the U.S. FDA's Stated Goal
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
FDA Inspectional objectives
Common areas for critical mistakes
Recent trends and events
The compliance audit
Who Will Benefit
Quality Systems Personnel
Internal and Supplier Auditor Personnel
R&D and Engineering Staff
CAPA and P&PC Personnel
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.