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

This 90-minute webinar will evaluate the chief areas of an FDA CGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA 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.

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'.

Who Will Benefit:

This training will benefit personnel/ companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceuticals and Biologics fields. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance