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How to Develop a Risk Based Biological Safety Evaluation Per New US FDA Guidance


This three day course will incorporate the new US FDA guidance on biocompatibility into the three main steps in developing a Biological Safety Evaluation (BSE): Biological Evaluation Plan (BEP), Testing Options, and Biological Evaluation Report (BER). Composed of three one-hour presentations foll...

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This three day course will incorporate the new US FDA guidance on biocompatibility into the three main steps in developing a Biological Safety Evaluation (BSE): Biological Evaluation Plan (BEP), Testing Options, and Biological Evaluation Report (BER). Composed of three one-hour presentations followed by Q&A sessions, the course will cover each step in developing a BSE in detail. This course will provide insight into regulatory expectations when it comes to evaluating device safety.

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>Duration:60-minutes per day
>Dates and locations:August 30, 2016 - September 1, 2016
>Website:http://eventcallregistration.com/reg/index.jsp?cid...
>Hosted by:

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Nelson Laboratories, LLC

http://www.nelsonlabs.com
E: [email protected]
T: (801) 290-7500
F: (801) 290-7998

Address
6280 S. Redwood Rd., Salt Lake City, UT, 84123, United States
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Espergaerde, Denmark
Aa. Louis-Hansens Alle 11
Espergaerde
3060
Denmark
T +45 (0) 49 12 79 72

Gibraltar Laboratories, Fairfield, New Jersey, USA
122 Fairfield Road
Fairfield, NJ
07004-2405
United States
T (973) 227-6882

Itasca, Illinois, USA
1500 W. Thorndale Ave
Itasca, IL
60143
United States
T (630) 285-9121

Mexico City, Mexico
James Watt No. 22
Cuautitlan Izacalli
Mexico
CP 54730
Mexico
T + 52 (55) 2620 9076

Nelson Labs Europe – Leuven, Belgium
Romeinsestraat 12
Leuven
3001
Belgium
T +32 (0) 16 40 04 84

Ontario, California, USA
687 S. Wanamaker Avenue
Ontario, CA
91761
United States
T (909) 969-2302

 
 
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