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.
Why should you attend?
Any pharmaceutical worker, who performs, supervises or reviews development, validation, or manufacturing processes needs to develop an understanding of the operations of a QC laboratory. This is particularly true for workers in Regulatory Affairs, Quality Control and Quality Assurance as many of the required activities and their documentation will be assigned to them either for performance or review. All pharmaceutical workers who have responsibilities related to product quality should understand the regulatory requirements applicable to the QC laboratory as they are a routine part of pharmaceutical development and manufacturing, and must become a part of the body of knowledge possessed by senior workers.
Who will benefit:
• Supervisors, and lead workers in Product and Process Development
• Regulatory Affairs
• Quality Assurance and Quality Control
• Quality Control workers who will be participating in operations or the supervision of the development
• Manufacturing, or testing of medicinal products will benefit from knowing the procedures and applications applicable to the quality control laboratory
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.
Meet your Expert:
Dr. Steven Kuwahara, Ph.D. is the founder and Principal of GXP Biotechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.