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Manufacturing Combinations Products & FDA Regulations at MD&M East Workshop

Thu, 06/13/2013 - 3:38pm
Microtest Laboratories

Medical device professionals will learn what they need to know about manufacturing combinations products and FDA Regulations at a workshop to be featured at MD&M East, the world's largest medical OEM event, in Philadelphia on Tuesday, June 18, 2013.

Titled “Combination Products: What You Need to Know,” the workshop will outline a realistic approach for medical device professionals to use in navigating the regulatory standards required for the approval, marketing, and manufacture of combination products. Topics will include:

  • Defining a Combination Product
  • Current and pending FDA regulations re: their approval, marketing, and manufacture
  • Self-assessing the Primary Mode of Action (PMOA)
  • Integrating with the FDA through the Request for Designation (RFD) Guidance from the Office of Combination Products (OCP)
  • GMP issues involving the manufacture of a drug component with a medical device
  • Differences between medical device cGMPs and pharmaceutical cGMPs: Jargon, regulations, and general culture
  • Real-world case studies
  • Questions & answers

Microtest Laboratories Director of Project Management, Manufacturing, Alex Mello will lead the workshop. Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Mello has more than 20 years of experience in Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Products, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRCM).

 “Combination Products: What You Need to Know” will be featured at MD&M East as part of the event’s “Innovation Briefs” series. The workshop will be held on Tuesday, June 18 at 1 p.m. in booth #957. Attendance is free for MD&M East guests and participants. For more information, contact Microtest Laboratories by phone at 1-800-631-1680 or by email at amello@microtestlabs.com.

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