Session: Advanced Materials in Health Care-Safety and Efficacy of Rubber for Biomedical Applications (Fall 180th Technical Meeting & Advanced Materials in Health Care)


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Advanced Materials in Health Care-Safety and Efficacy of Rubber for Biomedical Applications

Thursday, October 13, 2011: 2:00 PM-5:45 PM

Meeting Room #13 (The I-X Center)

Chair:

Kimberley Dempsey-miller, West Pharmaceuticals Services

2:00 PM

HC19

Integrating Design Transfer with Technology and Product Development

Jerome Parmer, Ph.D., Consultant, Chester, NJ

2:30 PM

HC20

CANCELLED - Bio-Medical Advances In Polyphosphazene Rubber Materials

Steve Kyker, R & D, Materials Science Technology, Inc., Conroe, TX and Al Temple, Sales & Marketing, Materials Science Technology, Inc., Conroe, TX

3:00 PM

HC21

Drug Master Files and cGMP

Debbie M. Thomas, Global Regulatory Affairs, West Pharmaceutical Services, Lionville, PA

3:30 PM

Break

3:45 PM

HC22

Bioburden and Its Effect On Sterilization of Elastomers In Medical Devices and How Antimicrobials Fit Into the Picture

Len Czuba, Czuba Enterprises, Inc., Lombard, IL

4:15 PM

HC23

Sterilization of Health Care Products Following ISO 11137 -- Practical Aspects of Electron Beam Processing of Medical Devices

Dan Yasenchak, E-BEAM Services, Inc., Lebanon, OH

4:45 PM

HC24

The Extractables Study: What It Means in the Pharmaceutical Industry

Laura B. Stubbs, West Pharmaceuticals, Lionville, PA

5:15 PM

HC25

Assessing the Potential Toxicity of Extractables and Leachables From Plastic and Rubber Components Into Drug Products

Allan W. Ader, SafeBridge Consultants, Inc., Mountain View, CA

Advanced Materials in Health Care-Safety and Efficacy of Rubber for Biomedical Applications

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