LIVE WEBINAR – From Manufacturer to Consumer: Compounded Drug Quality Through the Supply Chain
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LIVE WEBINAR: From Manufacturer to Consumer: Compounded Drug Quality Through the Supply Chain
Speakers: Michael R. Alexander, JD, Attorney; Blinn E. Combs, JD, Ph.D., Attorney; Bradley W. Howard, JD, Attorney
Webinar Date: Wednesday, December 2, 12:00 P.M. CST
Session Description:
Compounded-drug quality depends upon effective oversight of every stage of the supply chain, beginning with the sourcing of active pharmaceutical ingredients and extending through testing, distribution, and delivery to the patient. This program reviews the legal, regulatory, and quality requirements applicable to supplier qualification, certificates of analysis, laboratory testing, supply-chain integrity, transportation controls, and emerging peptide-compounding developments. Participants will gain practical tools to identify quality risks, evaluate supply-chain participants, and strengthen compliance programs designed to support patient safety and regulatory compliance. The presentation uses recent regulatory developments and peptide-related case studies to illustrate how quality-system principles can be applied throughout the compounded-drug supply chain.
Learning Objectives:
- Outline the legal and quality obligations applicable at each stage of the compounded-drug supply chain.
- Identify whether an API manufacturer, repackager, importer, and supplier are appropriately registered, licensed, and qualified.
- Identify limitations and critical areas of potential risk in the quality of compounded products–such as purity, sterility, and stability–and what resources are available to address these considerations.
Register Today: https://event.on24.com/wcc/r/5541985/452B4FA1A3262237A1540B8D28B79BFF