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

This webinar focuses on the critical steps to avoid U.S. FDA warning letters by understanding the agency's latest aggressive enforcement plans. Learn how to navigate evolving FDA/cGMP regulations, prioritize limited resources, and tackle common inspection pitfalls. Gain valuable insights into recent trends, compliance audits, and FDA inspection objectives to ensure your company is audit-ready. Attendees will understand the most common mistakes that lead to non-compliance and how to proactively stay ahead of regulatory challenges. Equip yourself with the knowledge to safeguard your operations and prevent costly enforcement actions.

AREAS COVERED IN THE SESSION:

• The U.S. FDA's new aggressive implementation plans
• Proactive reviews of the applicable U.S. FDA / cGMP requirements
• Key areas to focus limited resources
• FDA Inspectional Objectives
• Common areas for critical mistakes
• Recent trends and events
• The compliance audit
• Q&A

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Internal and Supplier Auditors
• CAPA and P&PC personnel desiring to optimize systems and responses in harmony with the U.S. FDA's quality management systems / cGMP expectations.

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

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.