Webinars>>​CGMP (FDA Regulation and Compliance)
FDA’s CGMP - A Changing Paradigm

​There seems to be a general shift in the FDA’s CGMP audit paradigm and the companies that fall under FDA’s jurisdiction need to be aware of these major shifts. The reason for the shift is because a number of companies still do not comply to CGMP guidelines the way they should and get involved in fraudulent activities. The agency continues to use high-profile cases to drive compliance to smaller companies and suppliers.
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This webinar will help the regulated companies in evaluating their existing compliance and internal audit in light of the changes in FDA’s CGMP audit paradigm. The webinar will teach attendees to be ready and compliant and will provide expert guidance on how to make your CGMP compliance inviolable. 

Areas Covered in the Session: 
  • Avoid complacency from past good U.S. FDA/ EU ISO audits
  • The 10 key steps
  •  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
Who will benefit:
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This webinar will provide valuable assistance to all personnel in:
  • Senior Management
  • Regulatory Affairs
  • Quality Assurance 
  • Production
  • Engineering
  • Personnel involved in a U.S. FDA-regulated environment
  • Personnel involved in complaint handling, non-conforming material, out-of-specification, failure investigations, root cause analysis, labeling, distribution, storage, tracking and use of regulated medical products.
Date: April 13, 2016
Time: 1 PM-2 PM ET   Duration: 60 Minutes

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: [email protected]