2013-12-16 08:17:51 - This webinar will examine the U.S. FDA's annual "Strategic Priorities" initiative, with emphasis on 2014 and beyond. It will focus on the broad range of issues a company's senior management and QA/RA staff need to consider in their annual Management Review of their existing quality management system.
Description of the topic
Such a mandated review is all the more urgent due to the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what the FDA and industry need to do internally. Further evaluation of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of applicable FDA "Strategic Priorities" areas for required review or related industry problem areas. Major 510(k) changes will be discussed, as will the new combination products CFRs and pharma requirements.
you should attend
Each year companies are to perform a complete review of their quality management system and its ability to meet the current GMP's. The U.S. FDA has added a "Strategic Priorities" initiative, expanded yearly, that can assist companies to proactively address areas of GMP concern. There are major shifts ongoing in the emphasis of the U.S. FDA cGMP compliance audits, clinical trial expectations, product submission requirements and company response expectations. All regulatory areas are under on-going re-evaluation by the FDA, and need to be revisited periodically by a company's QA/RA and its senior management. This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Ongoing negative publicity regarding pharmaceuticals, devices, as well as events in unrelated industries have put pressure on the Agency to "get tough on compliance / enforcement". This webinar examine / review FDA's "must-have's" for corporate CGMP compliance.
Areas Covered In the Seminar
The FDA's "Strategic Priorities" for 2014 and Beyond
Mandated Areas for Annual Reviews
Tougher Regulatory Science -- What "Better Science" Really Means
Device, Pharmaceutical and Biological Issues
General CGMP Issues -- Strengthened Compliance
Major / Pending 510(k) Changes
Safety / Integrity of Global Supply Chain
Who will benefit
Q/A Session with the Expert to ask your question
Handouts (PDF print only copy of PowerPoint slides)
90 Minutes Live Presentation
Certificate of Attendance