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Elements of a GMP-Compliant Quality Control Lab
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10/2/2015
When: 10/02/2015
1:00 PM - 5:00 PM
Where: Biotility UF CERHB
13706 Innovation Dr
Alachua, Florida  32615
United States
Contact: Tammy Mandell
386-462-6397

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Elements of a cGMP Compliant Quality Control Laboratory

The quality control (QC) unit serves an important role in the (bio)pharmaceutical industry byassessing and measuring specific and pre-defined parameters to ensure the safety and quality of (bio)pharmaceutical products. Topics discussed in this course include an overview of regulatory requirements, QC laboratory activities including raw materials, in-process and finished product testing, and handling out-of-specification (OOS) test results. Equipment qualification, method validation, and vendor qualification will also be covered. Practical examples, case studies and hands-on activities will be used to illustrate FDA QC laboratory hot button issues and regulatory compliance as related to the GMP-compliant QC unit.   

DATE: Oct. 2, 2015  TIME: 1:00 - 5:00                      REGISTRATION FEE: $150

 

Register here: http://biotility.research.ufl.edu/ind-prof.html

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