Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer
Course - Los Angeles, CA, United States
Upon completion of this course, you will:
Be conversant in the specialized language of laboratory compliance
Be very familiar with the cGMPs and other regulations as they impact QC labs
Know the current compliance “hot spots” that FDA and other regulatory authorities look for when inspecting QC labs
Understand how to effectively deal with laboratory deviations and OOS results
Have an understanding the what, how and why of laboratory equipment qualification and methods validation
Understand how to properly prepare your QC lab for audits and inspections
This course is intended to give participants a thorough overview and practical understanding of Current Good Manufacturing Practices for laboratory compliance including:
General requirements for design and construction of analytical laboratories
Calibration and Qualification of instrumentation and equipment
Documentation, records-keeping and change control
Management of reagents, test solutions and reference standards
Personnel development and training
Organization: The Center for Professional Innovation & Education
(Courtesy of The Center for Professional Innvovation and Education, Inc. logo, via http://www.cfpie.com)
Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer
Thu, Aug 22, 2013 - Fri, Aug 23, 2013
The Hilton Los Angeles Airport (LAX)
5711 West Century Blvd., Los Angeles, CA 90045, United States
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