FDA’s Draft Guidance – Request for Quality Metrics - Webinar CD/Transcript

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FDA’s Draft Guidance – Request for Quality Metrics: What All Drug and Biologics Manufacturers Need to Know

This past July the FDA issued the long awaited Guidance for Industry, “Request for Quality Metrics.” This guidance is the FDA’s latest effort toward improving compliance and inspection practices and applies to individuals that own or operate an establishment that is engaged in the manufacture, preparation, propagation, compounding or processing of a drug.

With the draft guidance still in the public comment phase, now is the time to gain a complete understanding. The comment phase was extended from September 28th to November 27th following the public meeting on August 24th.

Join industry expert Andrew Harrison as he provides an overview of the guidance along with details on the specific quality metrics being requested. He’ll also provide advice on how your company can use this information to improve your compliance position with the FDA.

In 90 minutes you’ll have a complete understanding of:

  • What the guidance means for your company
  • What information you should be prepared to submit
  • How the FDA intends to use the quality metrics data
  • Who is required to comply
  • What data the FDA is proposing to be reported
  • When the metrics/data should be reported
  • How the data will be submitted
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Data management and statistics personnel
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • Risk management specialists
  • Training personnel

Andrew Harrison is the Chief Regulatory Affairs Officer & General Counsel at Regulatory Compliance Associates, Inc. Prior to that, he was Vice President, Global Quality Compliance & Audit at GE Healthcare where he won the Chief Quality Officer's award in 2012. He has over fifteen years of experience as a highly-accomplished Quality & Regulatory compliance leader, attorney and competitive differentiator across the Medical Device, Pharmaceutical and Biotechnology sectors. He is an Illinois-licensed attorney and an industry speaker in key forums on various regulatory & legal topics.