Description

Overview: This webinar will examine 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.

Such a 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 it (the FDA and industry) need to do internally. A 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 101 areas of required review or industry problem areas. 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. To add to the urgency, there has been 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 101 must-have`s for corporate compliance.

Areas Covered in the Session: