This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs.
It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously accepted validation methods, and will provide thought-provoking questions for FDA-regulated companies. Enhanced use of existing FDA tools by a company will be discussed. What are the expected industry trends for the future as indicated by recent FDA and other guidance documents, for which companies should now prepare?
Why Should You Attend:
The FDA expects companies to perform meaningful, results driven manufacturing process validation, now including considering life cycle issues. While the company is held fully responsible for deciding how it will conduct process validation, alternate approaches require longer and more stringent documented rationale. Growing high-profile field problems indicate that validation and change control and its effect on regulatory review activities are not yet fully utilizing the power of current FDA guidance and associated tools, which must be a part of such an analysis. A growing push by the Agency to toughen the regulatory process in the U.S. is one result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but require the implementation of formal methods with documented and defensible rationale.
Areas Covered In the Session:
Who will benefit:
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.
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/Process_Verification
LinkedIn Like us
Twitter Follow us
Facebook Like us