Best practices for preparation and code of conduct.
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 attendees ask anything from us.
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
-And more!
How To Conduct:
-Quickly Turn Around Requests
-Make Copies of Everything
-Correct Observations Immediately
-Work with the investigator
-And more!
Resource Links:
Asa Waldstein www.AsaWaldstein.com
Steven Yeager [ Ссылка ]
Haley Chitty (Communication Specialist) [ Ссылка ]
FDA Investigators: Investigations Operations Manual 2021 [ Ссылка ]
Free AHPA Webinar: Preparing for FDA GMP Facility Inspections
[ Ссылка ]
Free AHPA Webinar: cGMP Basics for Hemp CBD Companies (great for supplement companies too! ([ Ссылка ]
Josh Long article on FDA inspections. [ Ссылка ]
AHPA Hemp-CBD Congress Videos! [ Ссылка ]
Regulatory: Blog, Events, Resources: [ Ссылка ]
AHPA Labeling Guidance Document: [ Ссылка ]
Asa’s Regulatory Consulting Company. Reducing regulatory risk in web & social media marketing. [ Ссылка ]
AHPA Prop 65 Guidance: [ Ссылка ]
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.
Asa Waldstein is a 20-year dietary supplement executive now focusing on bridging the compliance, marketing, and regulatory gap between the supplement and hemp industries. Asa is chair of the American Herbal Products Association’s (AHPA) Cannabis Committee. He also is CEO of the regulatory consulting company Supplement Advisory Group, and his Regulatory Education Series platform regularly hosts free events for the community. Asa is a Certified Clinical Herbalist and has helped oversee three FDA inspections with no 483's. Learn more and contact www.AsaWaldstein.com.
This was a great event!
Asa Waldstein
#RegulatoryEducationSeries #SupplementAdvisoryGroup
-The comments by myself and any presenters are considered educational only and are not intended as legal or regulatory advice.
