SMP Tech's Testing and Quality for Medical Products Forum November 14, 2012

The November 14, 2012 Testing and Quality for Medical Products Forum will include discussions of good practices with respect to the design, testing and manufacture of devices for FDA approval, as well as for the GMP auditing and quality systems. We will review some of the key requirements for a company to receive and maintain marketing approval from FDA and other regulatory bodies for mechanical testing.

We are excited to have Mike Silverman as our featured speaker. He has over 25 years of experience in reliability engineering, reliability management and reliability training. He is an experienced leader in reliability improvement through analysis and testing.

Mike Silverman is president of Ops A La Carte and will be providing product guidelines for life, safety and reliability testing. His presentation will show how you need reliability testing to ensure a safe and reliable product, as well as how to organize your test program and what constitutes the ideal test facility for a device. Mike will discuss the common deficiencies of test methods, including environment considerations, test configuration and equipment required.

Michelle Paganini of MP Associates will also be speaking. She has over 25 years of corporate experience in the Medical Device field and is experienced in both FDA Regulations and ISO Standards. She will discuss both the requirements and benefits of the Food and Drug Administration's mandated internal audit program for Medical Device Companies. She will also define what an internal quality systems audit program is and what the key requirements are for a successful program, along with the most common pitfalls. Michelle will explore how a successful audit program improves a company's bottom line and the basic principles involved.

Tom Roberts of SMP Tech, Inc., will be the Forum Moderator. After the presentations, a complimentary buffet lunch will be served to all attendees.

Official Website: http://www.smptech.com/MTX_Medical-21114.htm