FDAnews Announces: Combination Product GMP Compliance: Understanding FDA’s New Streamline Approach Webinar, April 28, 2015

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Manufacturing a drug or device is hard enough but for makers of combination products, things can get messy in a hurry. Noted combination products expert David Fox, a partner with Hogan Lovells in Washington, D.C. and former FDA Assistant Chief Counsel for Enforcement and Associate Chief Counsel for Drugs, will guide manufacturers through the draft guidance issued in January.

Combination Product GMP Compliance:
Understanding FDA’s New Streamline Approach
**FDAnews Webinar**
April 28, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/comboproductgmpcompliance

Manufacturing a drug or device is hard enough — even for companies with big budgets. For makers of combination products, things can get messy in a hurry.

In a 46-page draft guidance released in January, FDA clarified a 2013 final rule that specifies how combination product manufacturers should comply.

The heart of the guidance is the FDA’s view that product makers have two options for GMP compliance: satisfy all device and drug GMPs, or implement a streamlined quality system that focuses primarily on one but incorporates elements of the other.

Which one to choose is the million dollar (or more) question.

Noted combination products expert David Fox, a partner with Hogan Lovells in Washington, D.C. and former FDA Assistant Chief Counsel for Enforcement and Associate Chief Counsel for Drugs, will guide manufacturers through these difficult options.

This webinar will focus on:

  •     Understanding the 3 scenarios the FDA provided in the guidance to help manufacturers — can these examples be used to inform manufacturers’ strategy or are they too broad to apply to their situation?
  •     How manufacturers should describe their approach. The FDA advises manufacturers tell them through 510K filings what strategy will be used. This is new, as normally manufacturing details are not included in 510K applications.
  •     Whether the manufacturers need to update any of their supplier agreements or SOPs in light of the guidance. The FDA describes how to deal with third-party manufacturers, stressing that the sponsor of the combination product is responsible for ensuring all the contractors meet GMPs. But, if a contractor only manufactures the device part of a combination product, then it only has to meet QS regulations.
  •     How combination product makers should work with the FDA. Each combination product will be accepted by the agency center that will oversee its premarket review, and that will be the lead center and primary point of contact for applicants. Attendees will receive best practices on how to work with the center — particularly if it’s a center or review team a manufacturer is not familiar with.

Deciding what to do is complicated. Plus, the FDA is still taking comments on possible updates to the guidance. Know the details and be ready for the final guidance.

Meet the Presenter:
David Fox, Partner, Washington, D.C. office of Hogan Lovells has a leading practice in the regulation of new drugs and biological products, and also maintains a practice in the field of combination products. David served for more than six years with the Food and Drug Administration (FDA), as Assistant Chief Counsel for Enforcement from 1994 to 1995 and as Associate Chief Counsel for Drugs from 1995 to 2000. He has extensive experience in the approval process for new drugs and biological products, as well as the regulation of generic and follow-on products.

Who Will Benefit:
This course will be of benefit:

  •     Compliance personnel
  •     Regulatory affairs professionals
  •     QA/QC personnel
  •     Manufacturing executives
  •     510K application specialists

Conference Details:
Combination Product GMP Compliance:
Understanding FDA’s New Streamline Approach
**FDAnews Webinar**
April 28, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/comboproductgmpcompliance
Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/comboproductgmpcompliance
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
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