FDAnews Announces — FDA’s Draft Guidance — Request for Quality Metrics: What All Drug and Biologics Manufacturers Need to Know Webinar, Oct. 16, 2015

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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.

FDA’s Draft Guidance — Request for Quality Metrics:
What All Drug and Biologics Manufacturers Need to Know
**FDAnews Webinar**
Oct. 16, 2015 — 11:00 1.m. – 12:30 p.m. EDT
http://www.fdanews.com/fdasdraftguidance

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With the draft guidance still in the public comment phase, now is the time to gain a complete understanding.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 manufacturers can use this information to improve their compliance position with the FDA.

In 90 minutes attendees will have a complete understanding of:

  •     What the guidance means
  •     What information manufacturers 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

Meet the Presenter:
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.

Who Will Benefit:

  •     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

Conference Details:
FDA’s Draft Guidance — Request for Quality Metrics:
What All Drug and Biologics Manufacturers Need to Know
**FDAnews Webinar**
Oct. 16, 2015 — 11:00 1.m. – 12:30 p.m. EDT
http://www.fdanews.com/fdasdraftguidance

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/fdasdraftguidance
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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