Event:
-
Meet the Tougher U.S. FDA CGMPs
- Hosted By:
-
ComplianceOnline
- Start:
- Tuesday - Jun 04, 2013 10:00 AM
- End Time:
- Tuesday - Jun 04, 2013 11:30 AM
- Location:
- Online
- This training 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 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.
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.
Areas Covered in the Seminar:
- The "targets".
- Avoid complacency from past "good" U.S. FDA/ EU ISO audits.
- The basic underlying issues
- Proactive responses -- where to shift focus first
- Where to direct scarce resources
- A risk-based phased approach
- Avoid 'entropy' -- Prove 'in control'
- Maintain 'the edge'
- Website:
-
Visit the website for detail info