cGMP Compliance Series: How to Conduct & Manage a FDA Inspection

cGMP Compliance Series: How to Conduct & Manage a FDA Inspection

Presented: July 30, 2009

Published: Thursday, July 30, 2009

For many companies who have never been through an FDA inspection these may not only be new questions but likely nerve-racking ones as well. Wouldn't you like to have more than "some idea" of the authority the FDA has during an inspection, so you know what your rights are? As of June 25, 2009, the dietary supplement cGMPs are now in effect for those companies with 20 or more employees. This means that your facility could be subject to an FDA inspection AT ANY TIME, if you fall into this category. You should know what your rights are, what authority the inspectors have, and enable your staff to better understand the process and feel confident throughout it. This seminar will be an invaluable opportunity for you and your company to gain insight and practical information in a cost effective manner (with no travel costs!).

Take advantage of the expertise of these speakers:

  • Staci Eisner, regulatory affairs, quality assurance, research and development, and facility design for ExtractsPlus/PlusPharma, Quality and Regulatory Affairs Manager, Botanica Bioscience
  • Jim Prochnow, Esq, Greenberg Traurig, Adjunct Professor of Law at the University of Denver Law School
  • Steven Shapiro, Esq, Ullman, Shapiro & Ullman, LLP
  • Robert Ullman, Esq, Ullman, Shapiro & Ullman, LLP
  • Anthony L. Young, Esq, Kleinfeld, Kaplan and Becker, LLP
  • Mary Beth Watkins, BS, MS, Director of Quality and Compliance for Botanical Laboratories, Inc.
Materials in this packet include:
  • Course Outline, Speaker Bios
  • Transcripts to the two duplicate sessions, and answers to questions posed by attendees
  • Audio file

Related Materials include (can be purchased seperately):

  • AHPA Guidance: How to conduct a FDA Inspection
Member Price: $220.00
Non-Member Price: $520.00
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