AGAWAM, MASS. — 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 firstname.lastname@example.org.
About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.