AGAWAM, MASS. — October 2, 2013 — A full-day technical seminar designed to assist medical device and pharmaceuticals with what they need to know about manufacturing combinations products, including best practices and applicable FDA regulations, is scheduled for Thursday, October 31st, in Waltham, Mass., just outside Boston.
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 best practice and regulatory issues.
Titled “Combination Products: What You Need to Know,” the seminar will outline a realistic approach for manufacturers to navigate the testing, production, and regulatory standards related to the manufacture of combination products. Topics will include:
- Combination Products —What You Need To Know: Overview of regulatory hurdles for combination products highlighting the determination of PMOA.
- Applications of Lean to Combination Product Manufacturing: Case studies specific to applying lean to manufacturing of combo products for clinical use.
- In-Process and Release Testing PTC: Outline of in-process and release testing points to consider during development and specification determination.
- EM Monitoring of GMP Manufacturing Space: Current EM procedures for setting up GMP manufacturing.
- Choosing the Right CMO: Discussion of best practices to determine a right fit CMO.
“Combination Products: What You Need to Know,” will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. The seminar will be held at the Conference Center at Waltham Woods in Waltham, Mass., just outside Boston, on Thursday, October 31, 2013, from 9:00 a.m. to 3:00 p.m. Registration is at 9:00 a.m. Continental breakfast, break refreshments and luncheon is included.
To register, download the form at http://www.microtestlabs.com. Or, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at firstname.lastname@example.org. The registration fee is $149.
The seminar is one in a continuing series of technical events presented by Microtest Laboratories for medical device and pharmaceutical manufacturers. The seminars tend to fill up quickly so please register early! Follow Microtest Laboratories on Facebook at http://goo.gl/pHNP63, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.
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.