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Elements of a cGMP-Compliant Quality Control Lab
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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.

1/12/2015
When: 01/12/2015
9:00 AM - 4:00 PM
Where: Biotility UF CERHB
13706 Innovation Drive
Alachua, Florida  32615
United States
Contact: Tammy Mandel
(386) 462-6397

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Elements of a cGMP-Compliant Quality Control Lab

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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.

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DATES: January 12, 2015
PRICE: $350

TIME: 9:00 a.m. - 4:00 p.m.

About BioFlorida

BioFlorida represents nearly 6,000 establishments and research organizations in the biopharmaceutical, medical technology and bioagriculture sectors that collectively employ nearly 83,000 Floridians.

 

Members of the BioFlorida network include emerging and established life science companies, universities, research institutions, hospitals, medical centers, incubators, economic development agencies, investors and service providers.

 

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