Combination Products 3.0: Applying the New FDA Regulations in 2013

Thursday, October 31 2013
9:00 am – 3:00 pm

This event was posted by Microtest Laboratories, Inc.

Event Inquiries

1-800-631-1680 X192 or

Location: The Conference Center at Waltham Woods 860 Winter Street, Waltham, MA 02451

Combination products are a large and growing segment of the medical device market. Some analysts estimate they represent more than 30% of all new FDA product submissions. But for manufacturers the convergence of drugs, biologics, and devices presents a host of regulatory issues. This seminar will cover a range of topics including current trends for combination products, CMC specifics, in-process and final release testing, clean room design and monitoring, and an overall view on choosing the right CMO. Continental breakfast, break refreshments and luncheon is included.


Topics To Be Discussed Include:

  • Combination Products: What You Need to Know: Overview of regulatory hurdles for combination products highlighting the determination of PMOA., By Alex Mello, Director, Project Management – Microtest Laboratories
  • Application of Lean to Combination Product Manufacturing: Case studies specific to applying lean to manufacturing of combination products for clinical use., By Robert Langevin, Manufacturing Manager – Microtest Laboratories
  • In-process and Release Testing PTC: Outline of in-process and release testing points to consider during development and specification determination., By James Gebo, Sr. Research Scientist – Microtest Laboratories and Adi Tedla, Analytical Chemist – Microtest Laboratories
  • Environmental Monitoring of GMP Manufacturing Space: Current EM procedures for setting up GMP manufacturing., By Valerie Montgomery, Manager, Environmental Services – Microtest Laboratories
  • Choosing the Right CMO: Discussion of best practices to determine a right fit CMO., By Dawn Merdaa, Sales Manager – Microtest Laboratories

Fees: $149 (payment required in advance)

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