Steven Yeager and Asa Waldstein discuss tools on how to prepare for and execute a successful FDA inspection. This includes an "Ask Me Anything" session where you can ask anything from us.
This covers CFR 111 and also CFR 117 which have become more frequent.
How To Prepare: (Examples include)
-No Claims on Web & Social Media
-Outside of Building Clean/Back Doors locked (GMP prerequisite)
-SOP Ready: What to do during an FDA inspection
How To Conduct:
-Quickly Turn Around Requests
-Make Copies of Everything
-Correct Observations Immediately
-Work with investigator
-Steven Yeager is Director of Quality and Regulatory Affairs for Mountain Rose Herbs and has overseen several FDA GMP inspections. He is co-owner of the Columbines School of Botanical Studies and commonly presents on herbal medicine and GMP compliance. Steven is the current Chair of the American Herbal Products Association (AHPA) Board of Trustees and serves on the Board for the AHPA Foundation for Education and Research on Botanicals.
This is a Fireside Chat format so please submit your questions in advance!
Look forward to seeing you there!
-The comments by myself and any presenters are considered educational only, and are not intended as legal or regulatory advice.