Each year, companies are to perform a complete review of their quality management system and its ability to meet the current GMP's. The FDA has now added a "Strategic Priorities" initiative that is aimed at assisting companies to proactively address.
This webinar is about the FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on what it has for 2013. Each year, companies are to perform a complete review of their quality management system and its ability to meet the current GMP's. The FDA has now added a "Strategic Priorities" initiative that is aimed at assisting companies to proactively address areas of GMP concern.
There is a major shift in the emphasis of the U.S. FDA cGMP compliance audits, clinical trial expectations, product submissions and company response requirements. All regulatory areas are under evaluation by the FDA, and need to be revisited by a company's QA/RA and its senior management. This change in focus, brought about byrecent negative publicity on pharmaceuticals, devices, as well as events in unrelated industries, has a major impact on interpretation of individual compliance objectives, cGMP objectives, and indices of success.
This webinar will take a look at the list of FDA's mandatory requirements for corporate cGMP compliance. It will discuss the major 510 (K) changes already proposed, and will help organizations anticipate and address weak points of their quality management system. This will boost their chances of meeting compliance objectives.
Areas Covered in the Session:
1.The FDA's "Strategic Priorities" for 2013 and Beyond
2.Tougher Regulatory Science - What "Better Science" Really Means
3.Device, Pharmaceutical and Biological Issues
4.General cGMP Issues - Strengthened Compliance
5.Major Pending 510(k) Changes
6.FDA's Life Cycle View Requirements
7.Safety - Integrity of Global Supply Chain
8.Heightened Supplier Issues
9.FDA Clearance - Approval Only the Beginning - Product "Lifecycles"
When:January 9, 2013, 10:00 AM PDT | 01:00 PM EDT
John E. Lincoln, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and 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 have been described in peer-reviewed technical articles and workshops worldwide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt.
The webinar will benefit
1.Senior management in Drugs, Devices, Biologics, Dietary Supplements
Duration: 90 minutes
To enroll for this webinar, contact