cGMP Compliance Series: The Quality Unit

cGMP Compliance Series: The Quality Unit

Presented: December 14, 2006

Published: Thursday, December 14, 2006

As described in the proposed cGMP rules, your company must establish a Quality Unit, an independent group with unique responsibilities and authority to manage product excellence, consumer safety, compliance, company liability. The Quality Unit touches on nearly all manufacturing processes, from setting ingredient standards to ensuring they are met, qualifying third-party testing labs, packaging components and labeling, practical cost considerations and finished product quality.

This GMP compliance seminar focuses on establishing your company’s Quality Unit by outlining its responsibilities and roles, and offers practical insights from experienced experts. 

What you’ll learn from these experts to set up your company’s Quality unit efficiently and economically:

  • Warren Majerus, MS, Quality Systems Implementation, Inc., President — With nearly 30 years of experience in product development and Quality Control in food and supplement processing and analytical methods, Mr. Majerus is experienced in DSHEA- and CFR 110-based compliance auditing worldwide. He focuses on Auditor/Manufacturer/QC considerations, which include your Quality Unit’s scope of responsibility and authority, how to establish written specifications for materials and processes, and those specifications’ purpose and basis.
  • Daniel Stephens, MBA, Herb Pharm, Quality Control & Laboratory Services Manager — Involved in quality control and food safety compliance for nearly 30 years, Mr. Stephens has instituted and managed HACCP and ISO systems and audited quality assurance methods for production facilities, retail stores, storage sites and distribution centers. He shares his insights on industry/practical Considerations that the Quality Unit must address, including packaging components, raw materials, labeling, third party testing lab qualification, and finished products.
  • Anthony Young, Esq, General Counsel, American Herbal Products Association, partner with the law firm Kleinfeld, Kaplan and Becker, LLP — Practicing food, drug and environmental law since 1974, Mr. Young advises and represents domestic and foreign manufacturers with respect to compliance and defense of matters under the statutes enforced by the FDA, FTC, DEA, EPA, and more. He discusses the importance of the Quality Unit and legal liabilities.
If you haven’t started down this road, these speakers will provide solutions. And if your company already has a Quality Unit in place, these AHPA materials will help you identify new efficiencies or areas that need more resources.
Materials include:
  • The proposed cGMP regulation that clearly outlines the Quality Unit requirements
  • Presentations by Warren Majerus and Dan Stephens, with several supporting documents for each
  • Transcript, including answers to questions posed by attendees
  • Course Outline & Speakers Bios
  • Audio file
Member Price: $220.00
Non-Member Price: $520.00

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