Tougher U.S. FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel

Venue: Online Training Webinar

Location: Wilmington, Delaware, United States

Event Date/Time: Mar 09, 2011 End Date/Time: Mar 09, 2011
Report as Spam


Overview: 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 multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and recent public concern over insufficient oversite of new product introductions (and grandfathered product) by means of the 510(k) system. 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 much of their work for them. There will be no return to the past. Rather than be caught unprepared, proactively address these trends, and start to address areas of known deficiencies. 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. We will also discuss proven methods to prove to the FDA that known company cGMP deficiencies should not be a major concern to the Agency, and which may 'eliminate' the possibility of a deserved Warning Letter.

Why you should attend: The FDA says it's getting tougher. Recent audits and other enforcement actions indicate that's true. The past ways of doing things is not acceptable. The Agency continues to use 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. "Business as usual" is unacceptable. Recently several once 'model' companies have received multi-million dollar fines, with one facing criminal charges. Don't let you or your company be caught of guard by these major shifts in emphasis. Modify your internal audits to get 'in sync' with the FDA's shift in focus. Put in place a system to address areas of known deficiencies for FDA review.

Areas Covered in the Session:

* Key cGMP issues
* Avoid complacency from past "good" FDA/ ISO audits
* The desired response
* How to respond now -- where to shift focus first
* Where to direct scarce resources; A risk-based phased approach
* How to address known problem areas during an Audit
* Prove 'in control'
* Maintain 'the edge'

Who Will Benefit:

* Senior management in Drugs, Devices, Biologics, Dietary Supplements
* QA
* RA
* R&D
* Engineering
* Production
* Operations
* Consultants; others tasked with project leadership responsibilities


1000 N West Street | Suite 1200
United States