Submission of Quality Metrics Data - Webinar CD/Transcript

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Submission of Quality Metrics Data: The Why, the When and the What

The way drug and biologics concerns report quality metrics data to the FDA is about to change for good. A regulation nearing finalization will affect every company large and small that manufactures, prepares, propagates or compounds active ingredients or pharmaceutical products produced and sold in the U.S.

It’s vital to find out what’s in this reg-to-be — before it’s set in stone.

FDAnews has assembled a panel of FDA and industry experts with an inside track to the answers. You can participate without ever leaving your office.

Tune in for an advance look at this key regulation. You’ll discover:

  • How the final guidance will affect your operations
  • How the FDA intends to use the data collected
  • Who is required to comply — and who isn’t
  • Which data you must report, which you can safely skip
  • When the data must be reported, how it must be submitted
  • What’s happening with the PDA’s Quality Assessment Tool pilot program
  • And much more!

Your presenters include senior FDAer Denyse Baker, Susan Schniepp of Regulatory Compliance Associates Inc., and Amgen’s Cylia Chen Ooi. These three experts — with more than 70 years experience combined —  are sharing their insider knowledge on what quality data collection really means to you.

In a fast-paced hour and a half, they’ll deliver an overview of the guideline, details on specific quality metrics being requested and advise you on how to use this information to improve your firm’s compliance position with the FDA.

They will also discuss PDA’s Quality Culture Assessment Tool pilot program which is intended to help companies advance their overall quality culture. Using the tool, assessors will look at various aspects of a manufacturing site to determine how mature the quality culture is.

The final reg will be out before you know it. Seize this opportunity to get an advance look from people who know what they’re talking about.

  • Auditors and investigators
  • QA/QC compliance
  • Risk management
  • Data management and statistics
  • Trainers
  • Manufacturing directors and supervisors
  • Executive management
  • New hires
  • Legal counsel
  • Consultants/service providers

Meet Your Presenters

Denyse Baker, Senior Advisor, Scientific and Regulatory Affairs, PDA
Denyse Baker has 25 years of pharmaceutical industry and regulatory authority experience. Denyse started her career at Eli Lilly & Co. where she held leadership and management roles in engineering, parenteral manufacturing operations, and regulatory affairs both in the United States and Europe. She also worked for the FDA with responsibilities for the development and implementation of CDER Quality Systems for CMC Review.

Susan J. Schniepp, Fellow, Regulatory Compliance Associates Inc.
A pharmaceutical QA thought leader with 35 years’ experience, Ms. Schniepp has held leadership roles at Allergy Laboratories Inc., OsoBio Pharmaceuticals LLC, Searle, Abbott and Hospira. She is a director on the Parenteral Drug Assn. (PDA) board and has served as PDA / FDA Joint Regulatory Affairs Conference Chair, conference presenter, and Chair of the PDA’s Regulatory Affairs / Quality Advisory Board. She won PDA’s Distinguished Service Award in 2008.

Cylia Chen Ooi, External Affairs Senior Manager, International Quality, Amgen
Cylia Chen is the global lead of the GMP Intelligence program at Amgen, through her role; she is knowledgeable of the GMP/GDP/CMC requirements across different regions. She is currently leading the PDA Quality Culture Team. Cylia and her team have developed an assessment tool specific to biopharmaceutical industry to measure the quality culture of a site. The pilot of the tool is being completed later this year.