2014 - Webinar on Prepare for Your cGMP Inspection

This webinar will focus on the U.S. FDA's FY 2013 cGMP audit issues, recent guidance documents and stated 2014 initiatives.
Areas Covered in the Session :
Industry trends
Recent FDA actions / FY 2013 483 observations
The FDA's recently instituted annual "Strategic Priorities" initiative
Emphasis on 2014, and future issues
A review focusing on the broad range of issues a company's senior management and QA/RA need to consider in their annual Management Review of their existing quality management system / CGMP compliance
An additional review of recent information from the Agency
Other goals of the Agency that have already been translated into action
Further direction in areas of concern and what to expect in the future
Process validation
Wireless device guidance
The new UDI initiative and counterfitting concerns
The global supply chain, lifecycle, combo products, "better" science, and expanding "risk based" applications
Who Will Benefit:
This webinar will provide valuable information to all regulated in reviewing and modifying their regulatory complaince stance. Its principles apply to Personnel / Companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
Senior management
Middle management
Research & Development
Engineering
Software
QA / RA
Manufacturing
Operators
Consultants
cGMP Instructors
Verification and/or Validation Planning Teams
Execution and Documentation Teams
Compliance Trainings
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