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Overview: U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (cGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820). They are then required to translate those regulations into procedures and work instructions. Many companies who are successfully doing that are still failing audits, facing major recall, and multi-million dollar fines. What company failures contribute to this unnecessary result? What could / should be done differently? How do product hazard / risk management under ICH Q9 or ISO 14971 assist this process? How do companies address these issues now for audits that may be years in the future? Listen to an expert who wrote the definitive article on this subject in February 2002 and benefited from resulting industry feedback and utilization to this day. Why should you attend: Many industry cGMP 483 observations shouldn't have been received at all. Most Warning Letters could have been easily prevented. Yet the last few years have seen several major "names" in drugs and devices stumble over cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution. What can companies do proactively to address these concerns and better ensure better regulatory compliance? What can they do to eliminate negative audit findings that should never have been written in the first place. If 483's are received, how can Warning Letters be avoided? How can a company's positive actions be demonstrated to prevent their real achievements being short-circuited. What can companies do in addressing these issues? Why is "entropy" a major player? How can a company "put an auditor's mind at ease" before, during and after a cGMP compliance audit? How to address FDA District and Centre concerns? Presented by one who first "wrote the book" on such avoidance techniques in Feb 2002. Areas Covered in the Session: The "tougher" U. S. FDA and Regulatory "Hot Buttons" Recent news headlines - prominent / respected company failures Why do Companies Fail When They Are in Compliance Address Problems With an Eye to the Future Reviewing Company Compliance to These Issues Filling in the "Gaps" Entropy - a major "player" Who Will Benefit: Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Consultants others tasked with product, process, validations, cGMP responsibilities John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. AMAZINES.COM
Related Articles -
Online training, 483 Observations, Hot Buttons, U. S. FDA, FDA District, ISO 14971, 21 CFR Part 111,
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