Contract Manufacturers and their Customers: Best Practices for Effective Partnerships

Dietary supplement contract manufacturers and their “own-label distributor” customers must navigate a host of issues in order to establish effective business partnerships that ensure quality and compliance with federal laws and regulations.

Topics

• An overview of issues purchasers and manufactures should consider:
  • What information is needed to prepare a manufacturing quote?
  • How should specifications be set?
  • How are record keeping and quality control tasks assigned?
• Regulatory requirements for each party:
  • What does FDA expect during inspections?
  • How do the inspection obligations of the contract manufacturer differ from those of the own label distributor?
  • What manufacturing records should a distributor retain?
  • Who has responsibility for customer complaints and adverse events?
• Insights from veterans from both sides (manufacturers and distributors)
• Answers to participants' questions by an FDA official and legal and industry experts

Presenters

Tony Young -- Partner at Kleinfeld, Kaplan and Becker, LLP, and AHPA General Counsel

Cara Welch -- Team Leader of the Dietary Supplements Regulations Implementation Team in the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA)

David Morrison -- Vice President of Scientific and Regulatory Affairs at Vitamin Shoppe

Richard Kaufman -- Chief Operating Officer at Paragon Laboratories

Mitch Coven -- President of Vitality Works, Inc.

Michael McGuffin -- President of AHPA

Resources

• MP3 Audio file recording of the two-hour webinar
• White paper: The Relationship Between Dietary Supplement Contract Manufacturers and Packagers and their Customers -- DRAFT
• White paper: Records Requirements for Contract Manufacturers, Packagers and Distributors of Dietary Supplements -- DRAFT
• Checklist: Assigning responsibilities for contract manufacturers and their customers
• Sample distributor Request for Quote from a contract manufacturer
• Annotated Final Rule on Dietary Supplement cGMP
• Presenters’ slides

Cost

Members: $220

Non-members: $520