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Elements of a GMP-Compliant Quality Control Laboratory Course | Alachua
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 Export to Your Calendar 12/9/2016
When: 12/09/2016
1:00 pm - 5:00 pm
Where: Map this event »
Biotility at UF’s Center of Excellence for Regenerative Health Biotechnology
13706 Innovation Drive
Alachua, Florida  32615
United States
Contact: Tamara Mandell

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Please visit http://biotility.research.ufl.edu/biotility-calendar for more information.

 

The quality control (QC) unit serves an important role in the (bio)pharmaceutical industry by assessing and measuring specific and pre-defined parameters to ensure the safety and quality of (bio)pharmaceutical products. Erroneous QC laboratory analyses may have dire consequences for consumer health if out-of-specification product is sold. 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 laboratory. REGISTER

 

Please register here https://xms.dce.ufl.edu/reg/groups/CERHB/default.aspx?program=259&filter=&filtervalue=.


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