Succeed with the Tougher U.S. FDA cGMP Compliance Audits

Why Should You Attend:

There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.
The Agency has come under increasing negative publicity due to major, high profile drug and device problems / recalls, and public concerns over insufficient FDA oversight of new product introductions. In an effort to counter this public perception, FDA's audits have changed and have become less forgiving.

Businesses continue 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. There will be no return to the past.

During this session, we will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate. Attending this training will enhance your awareness and provide you the understanding necessary to modify internal audits to match this FDA shift. Upon completion of this training, you will be in a position to evaluate your existing compliance and internal audit emphasis in light of the changes in the FDA's CGMP audit "paradigm", identify gaps and then put in place the necessary fixes to ensure continuing compliance.

Areas Covered in the Seminar:

• The "target".
• Avoid complacency from past "good" U.S. FDA/ EU ISO audits.
• The desired response.
• How to respond now -- where to shift focus first.
• Where to direct scarce resources.
• A risk-based phased approach.
• Prove 'in control'.
• Maintain 'the edge'.