U.S. FDA's Strategic Priorities for 2013 and Beyond

Training Options

  •   Duration: 90 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $275.00
  • Refund Policy

Overview:

This webinar will examine the FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on 2013. Such a review will focus on the broad range of issues a company's senior management and QA-RA need to consider in their annual Management Review of their existing quality management system.

This review takes on added urgency as a result of 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. An additional review 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 already proposed will be discussed. The result will be a basis for such a management review and a listing of likely milestones and tasks. Anticipation and addressing of weak spots proactively will further prove a company is "in control", assist in timely review of submissions to the Agency, and in any remediation efforts.

Why should you 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 FDA has added a "Strategic Priorities" initiative that can assist 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.

In short, all regulatory areas are under evaluation by the FDA, and need to be revisited by a company's QA/RA and its senior management. There is "no business as usual". This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Recent negative publicity on pharmaceuticals, devices, as well as events in unrelated industries have put pressure on the Agency to "get tough on compliance- enforcement". This webinar will trigger such a response by an examination - review of FDA's "must-have's" for corporate cGMP compliance.

Areas Covered in the Session:

  • The FDA's "Strategic Priorities" for 2013 and Beyond
  • Tougher Regulatory Science - What "Better Science" Really Means
  • Device, Pharmaceutical and Biological Issues
  • General cGMP Issues - Strengthened Compliance
  • Major Pending 510(k) Changes
  • FDA's Life Cycle View Requirements
  • Safety - Integrity of Global Supply Chain
  • Heightened Supplier Issues
  • FDA Clearance - Approval Only the Beginning - Product "Lifecycles"

Who Will Benefit:
  • Senior management in Drugs, Devices, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants
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.


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