Tougher U.S. FDA cGMP Compliance Audits -- Raising the Bar/ Are You Ready?--ComplianceOnline-FDA Com (FDA Compliance Train)
|Event Date/Time: Nov 30, 2010||End Date/Time: Nov 30, 2010|
Recent audits indicate the past ways of doing things will no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. Recent events in regulated industries indicate a public's growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA.
How this is affecting the Agency's approach to audits and their expectations for companies. Pressure on the 510(k) process is only one example. They also use GMP compliance audits to drive companies to do much of their work for them. How they drive companies to do much of their work for them. 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.
This webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA's CGMP audit "paradigm". Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.
Areas Covered in the Seminar:
Avoid complacency from past "good" FDA audits.
Avoid complacency from just completed "good" 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'.