Course Detail

Chemistry and Technology of Polymeric Materials used in Medical Devices

Course Number: AP4225

Course dates to be announced.
Time: 8:00 AM - 4:00 PM
Location: Akron Polymer Training Center, Akron, OH 44325-5404
Cost: $600 USD
CEU's: 0.75
Instructor: Mr. David Russell

Course Overview

Intended for newcomers to the medical device industry, this course provides an introduction to FDA and EU regulations as related to medical devices including definition of key terminology, overview of GMP, device classification, listing and approval processes and how to navigate the FDA website to access key resources provided. A broad range of materials are discussed. This includes conventional elastomers such as silicones, natural and synthetic polyisoprene, and polyisobutlyene; thermoplastic elastomers such as TPEs, TPVs, POEs, Copolyamides and TPUs. Engineering plastics such as polyesters, nylons, acetals, polycarbonates, conventional polyolefins and cyclic polyolefins are discussed. Applications identified include orthopedic devices, ophthamolics, viscoelastic gels, catheters, tubing, stoppers, drapes, syringes, transdermal drug, medical machinery parts and the like.

Who Should Attend: Marketing and sales persons, product engineers, managers, quality professionals desiring to expand their knowledge into the realm of medical devices made from rubber and plastic materials. Pre-requisites; general technical aptitude and general familiarity of technical terminology related to rubber and plastic materials.

Course Outline

  1. Overview of FDA and EU Regulations
    • Key Definitions
    • Listings and Approvals
    • CE Marking, PMN(510K) and PMA( IDE)
    • GMP/Quality Systems Requierements
    • Common Specifications, Regulations, and Biocompatibilty Tests
    • The Biomaterials Access Assurance Act of 1998 (BAAA)
  2. Overview of Typical Application of Polymers in Medical Devices
  3. Thermoplastic Elastomers
    • TPVs, TPOs/Polyblends, POEs
    • Block Copolymers: TPUs, SBS, SIBS, CoPA, CoPES
  4. Engineering Plastics
    • Polyesters
    • Polyamides (nylon)
    • Polyolefins: PE, PP, Cyclic Olefins
  5. Conventional Elastomers
    • Natural Rubber and Polyisoprene (Synthetic)
    • Polyisobutylenes
    • Silicones
  6. Polymer Gels
    • Oil gels
    • Polymer Gels
    • Hydrogels
  7. Biodegradable Polymers
  8. Transdermal Drug Delivery Systems

Course Registration

General Course Registration:
Download a Printable Registration Form [PDF].

Registration Information:
Registration for a class is due three weeks prior to the scheduled class date.

All registrations must be guaranteed by check, a purchase order number or a credit card, otherwise the registration will not be processed. Checks should be made payable to "The Akron Polymer Training Center" and must include a copy of your completed registration form. COURSE FEES ARE DUE PRIOR TO ATTENDING.

All registrations whether by phone, fax or mail will be confirmed and considered binding and subject to all cancellation policies. If you do not receive a confirmation prior to the class, please call The Akron Polymer Training Center to verify your registration.

Course fee includes classroom instruction, instructional materials, parking permits, continental breakfast, lunch, beverages, and refreshment breaks. Travel and hotel accommodations are not included.

ENROLLMENT IS LIMITED AND ON A FIRST-COME, FIRST-SERVE BASIS. EARLY REGISTRATION IS STRONGLY RECOMMENDED!

Visit our registration webpage to view our cancellation/withdrawal policies.

The University of Akron

Akron, OH 44325
Phone: 330-972-7111
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