Live Webinar
on
Process Verification and Validation to Meet U.S. FDA Requirements
Date & Time: Wednesday, April 25, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: John E Lincoln
Location: Online
Price : $245.00
Register Now
(for one participant)
Instructor Profile:
Overview:
John E Lincoln Consultant, Medical device and Regulatory affairs,
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. FDA's new "science-based" initiative and their recent draft process validation guidance document will be considered. Enhanced use of existing FDA tools by a company will be discussed. And 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 highprofile field problems indicate that validation and change control and it’s effect on regulatory review activities are not yet fully utilizing the power of current FDA guidance and recent draft guidance and associated tools, which must be a part of such an analysis.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.
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 peerreviewed 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 FDAregulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. ...more
Suggest a Topic
More Webinars
Your Necessity is our Priority
Areas Covered in the Session: l l l l l l l l
Key process validation requirements Current expectations Recent process validation guidance documents
Lifecycle considerations ICH Q7, Q8 and the New Draft Guidance The "Controlled Process" The Three Stages of Process Validation Variation
Click here to register for this webinar Who Will Benefit: l
Senior Management
l
Regulatory Affairs Quality Assurance Production
l l l l
R&D and Engineering All personnel tasked with process verification and validation
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards,
Event-coordinator GlobalCompliancePanel
About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe