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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

Lab

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.

BioFlorida, Inc. | 901 NW 35th Street | Boca Raton, FL 33431
(P) 561-653-3839 (F) 561-653-3840 admin@bioflorida.com
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