Implementing a Risk-Based Internal cGMP Annual Audit Program
December 5, 2018 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:1-416-915-4458
There is an on-going major shift in the emphasis of U.S. FDA cGMP compliance audits. These changes have a major impact on individual compliance objectives, efforts and measurements of success. The Agency is concerned with the major, high profile drug and device problems / recalls, and public concerns over insufficient FDA oversight of new product introductions. Business continues to “shoot itself in the foot”, including once highly respected companies. All this affects the Agency’s approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do some of their work for them. And they’re “piercing the corporate veil” to prosecute senior management involved in lying or fraud. Emphasis is now on better science, lifecycle and reduction in variance, correct metrics, and risk-based cGMP activities. This webinar will evaluate the key areas of an FDA cGMP compliance audit, and evaluate actual and anticipated changes in emphasis based on this new regulatory climate.