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  • FDA Supplier Audits: As a Bio-pharmaceutical or Medical
    Device Supplier, How Do You Prepare For an FDA Audit?

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Jun 13, 2013 10:00 AM
  • End Time:
  • Thursday - Jun 13, 2013 11:00 AM
  • Location:
  • Online
  • This webinar on FDA supplier audits will discuss the best practices and provide practical tips to prepare for FDA audits, as well as client audits. This training has been designed specifically for bio-pharmaceutical and medical device suppliers.

    Why Should You Attend:

    Are you a supplier of raw materials, component parts or finished product to biopharma or medical device companies? The supply chain for pharmaceuticals, biologics and medical device companies are increasingly being audited by their clients. FDA regulations define that vendor supplier oversight is absolutely critical to a strong quality management system. But many suppliers not only have to prepare for client audits, they also need to prepare for FDA audits.

    This webinar will review the regulations about supplier responsibilities, educate participants on best practices and provide tips for preparing for an FDA audit. We will help you map out a plan for pre-approval inspection (PAI) readiness in your company and share what you can expect during a FDA audit.

    Areas Covered in the Webinar:

    - Review of FDA regulations for supply chain oversight
    - The role of vendor oversight in quality management systems
    - Best practices and tips for a successful audit
    - Determine if you might be part of the PAI process as a supplier
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