Looks like this event has already ended.
Check out upcoming events by this organizer, or organize your very own event.
The Most Serious FDA 483s - How to Avoid Them
Tuesday, March 5, 2013 from 10:00 AM to 11:30 AM (PST)
Palo Alto, CA
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
Why Should You Attend:
Recent FDA audits indicate a shift in the top serious Form 483 observations.
This webinar will evaluate the chief areas of FDA CGMP compliance audits based on recent top 483 findings to see actual and anticipated changes in emphasis, and how to better prepare with a company's internal audit program .
This 90-minute session will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changed FDA focus based on recent 483 analysis, and their audit "paradigm". Such analysis allows a company to evaluate/ perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.
Areas Covered in the Webinar:
- Recent Most Serious FDA 483s
- The "Whys"
- Root Causes
- Avoid complacency from past "good" FDA audits.
- Shifting focus
- Maximize scarce resources
- The "risk-based" phased approach
- Maintain "the edge" -- fight "entropy"
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.