Design of Practical, Relevant and Robust Laboratory Testing Strategies for Medical Device Materials - 12/3/2009
Time: Registration: 7:30 am - 8:00 am
Program: 8:00 am - 9:30 am
Chemical Characterization and Material Analysis, Extractable / Leachable Studies, and Assessing Surface Cleanliness
Regulatory trends are toward providing more quantitative chemical data to characterize device materials, demonstrate control and consistent manufacturing, and to support the label claims placed on medical devices. This program will provide insights into the laboratory design of studies for evaluation of biocompatibility through material and chemical properties of device relevant materials according to ISO 10993: How to design practical, relevant and robust test strategies for novel material technologies; technical challenges with testing and choosing suitable analytical test methods; methods and procedures to evaluate surface cleanliness.
Pace Analytical Life Sciences is a full service contract analytical testing laboratory providing chemistry and microbiology testing services to the pharmaceutical and medical device industries. Services include methods development/validation, raw material testing, stability testing and storage, product release testing, chemical characterization and residual chemical analysis. Pace Analytical Life Sciences operates two laboratories, one located in Oakdale, MN, and the other in San German, Puerto Rico. We are FDA established, DEA registered and ISO/IES 17025 accredited.
Who should attend?
R&D Engineers, R& D Managers, Quality Engineers, Quality Managers, Regulatory Affairs, Manufacturing Engineers, and Senior Management
Information / skills to take away from course:
Chemical testing, when used properly, provides quantitative data resulting in valuable insight to your material characteristics, your manufacturing processes and is a cost-effective approach to process / product control.
If you are challenged to reduce costs while improving quality and productivity, material characterization may help you. Assessing your materials, early in the product development process, can help reduce risk of product failures.
Mark Schwab, Director of Medical Device Chemistry, Pace Analytical Life Sciences - Oakdale Location
Mark Schwab is the Director of Medical Device and Method Development and Validation Chemistry for Pace Analytical Life Sciences. Mark has been with Pace Analytical for over 13 years and brings extensive experience in developing and validating analytical methods used to characterize materials used in the Medical Device and Pharmaceutical industries. He is responsible for overseeing the activities associated with the development of new analytical technologies as well as the development of testing services to meet the requirements of ISO 10993. He is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) and is a voting member in AAMI/BE/WG 14 Material Characterization and AAMI/BE/WG 63 Sterilization Residuals Working Groups.
The following topics will be addressed:
Manufacturing / Quality
Contact us to discuss your testing needs. 612-607-1700 Email Us