Herbal supplement manufacturers and marketers need to have an solid understanding of current Good Manufacturing Practices (cGMP). In this interactive presentation you'll learn about the intricacies of cGMP, including all CFR 111 subparts. We'll give you examples about how to comply with each section, practical steps for implementing them in your facility, and common mistakes to avoid. We also provide real world examples of how to prepare for (and act) should you have to undergo an FDA inspection.
Asa Waldstein (CCH) is a graduate of Rocky Mountain Center for Botanical Studies and has been manufacturing dietary supplements since 2001. He is a Board of Trustee at the American Herbal Products Association (AHPA) and is Chair of AHPA's large Cannabis Committee. Asa routinely speaks about cGMP compliance, FDA inspection preparation from a manufacturer perspective and FDA, FTC, and class action trends. He has overseen three FDA inspections with no 483's!
Steven is Director of Quality for Mountain Rose Herbs and has overseen several FDA GMP inspections. He is co-owner of the Columbine School of Botanical Studies and commonly presents on herbal medicine and GMP compliance. Steven is an elected trustee of the American Herbal Products Association (AHPA) and serves on the Board for the AHPA Foundation for Education and Research on Botanicals.