Live In-Person Seminar on “GMP Compliance for Pharmaceutical Quality Control Laboratories” 2014

This course is designed for people who are growing in their knowledge of pharmaceutical quality control practices and regulations. It will be a "how to" course where the instructor will explain the reasoning as well as the procedures that should be used to meet the various requirements of the pharmaceutical QC laboratory. The instructor will present different areas of work with a "how to" approach so that the seminar participant can see how the subject matter applies to the participant's work either now or in the future. In addition to discussing the particular subjects he will explain how pharmaceutical regulatory requirements can be met when conducting the work. The instructor has decades of experience in working with a pharmaceutical QC laboratory within the regulated pharmaceutical industry in the US. He will be covering topics that he is familiar with and will present them in a manner aimed at workers who may have been introduced to basic QC practices and regulations, and now wish to expand their knowledge base.

Course Outline/Agenda:
Day One: The Pharmaceutical Quality Control Laboratory
Lecture 1: General Considerations
Lecture 2: Animal testing and GLP laboratories
Lecture 3: The GMP regulations
Lecture 4: The Microbiology Laboratory

Day Two: Going Beyond the Basics
Lecture 5: Out-of-Specification (OOS) test results
Lecture 6: Test Method Validations
Lecture 7: Statistical problems with testing.
Lecture 8: Dealing with multiple outcomes from different sources.