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Regulatory Considerations, Strategy and Best Practices for Choosing a Quality Contract Manufacturing Organization (CMO)


Bryan J. Coleman (Senior Director, Pharmaceutical & Device Consulting Services, EAS Consulting Group)

Location: 119B

Date: Tuesday, April 24

Time: 3:30pm - 4:15pm

Pass Type: Conference Pass, VIP Attendee - Get your pass now!

Track: Drug Manufacturing

Vault Recording: TBD

New drug development presents a myriad of challenges, particularly when a choosing to work with a CMO. Critical decisions will ultimately affect your ability to produce a therapeutic agent that delivers high quality results on time and on budget.

Will the CMO produce only Phase 1 or 2 product or will it be able to meet the demand of Phase 3 and beyond (commercialization)? Can they compliantly scale-up operations for anticipated growth? Are they in compliance with strict government and regulatory requirements, producing to USFDA requirements of cGMP standards? Is the CMO able to adequately track key performance measures to support your product?

Learn the important questions to ask and how to assess competencies as potential CMO partners are assessed to ensure your needs are met across the spectrum of compliance, production, quality, communication and more. Preparation, teamwork and planning will determine the success of your CMO partnership.

Learning objectives:

  • Strategies in choosing a CMO – Questions to ask, documentation to request
  • Warning Signs - Are they overpromising and under-delivering?
  • Think like a CMO to avoid pitfalls to anticipate their needs to meet yours

Presentation Files