Good Manufacturing Practices
BIOL-40000
Gain a comprehensive understanding in FDA compliance with current good manufacturing practices (cGMPs), as regulated and guided by national and international agencies for the pharmaceutical and industry. The course will emphasize the US FDA cGMPs and briefly touch on differences between the other regional markets in the rest of the world. In addition to pharmaceutical applications, nutritional supplements will also be discussed since this industry is held to standards very similar to therapeutics.
The goal of this course is to teach you how to apply the knowledge gained about GMP regulations to institutions that are either trying to develop clinical trial materials or commercial product for human or veterinary treatment to assure compliance. Teaching the foundation of current Good Manufacturing Practices and similar legislative edicts in other countries that are applied to Chemistry Manufacturing and Controls (CMC) in the biotechnology, pharmaceutical and nutritional supplement industries should provide that knowledge base.
Learning Objectives
-
Understand the FDA's basic Good Manufacturing Practices regulations
-
Understand the historical evolution of current Good Manufacturing Practices
-
Understand the regulatory structure of other countries that follow GMPs
-
Understand the application of guidance documents to the GMPs (ICH and FDA)
-
Develop a basic Quality Management System to manage GMPs
-
Use risk management tools in developing a compliance strategy
-
Respond with solutions to practical case studies as a learning tool.
Course Information
Course sessions
Section ID:
Class type:
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
No textbook required.
Policies:
- No refunds after: 1/20/2025
Schedule:
Instructor:
Mitchell Rosner, Ph.D.
Principal Consultant at Quality Consulting Associates.
Mitchell H Rosner has a broad background in pharmaceuticals, biologics, device, food and nutritional supplements industries. His work at virtual and start-up companies and large multi-national entities has enabled him to provide value-added contributions at all types of organizations. He has contributed to 6 approved products and has multiple patents. Rosner has held several leadership positions in his career. He is a certified chemist (ACS), project manager (MPM through AAPM), HACCP manager (NEHA) and auditor (CQA and CBA through ASQ).
Rosner received his B.S. in chemistry from George Washington University (1982), a M.S. in toxicology (1985) and a Ph.D. in pharmacology and toxicology with a minor in pharmaceutical sciences (1989) from the University of Arizona. He began his career as a toxicologist but changed his scope of work to include analytical, formulation and process development, design of instrumentation, technology-transfer, validation, quality control and quality assurance.
Rosner began his industrial career as an analytical biochemist at IDEC Pharmaceuticals (now Biogen) and continued his applied analytical career at CV Therapeutics (now Gilead Sciences), Nektar Therapeutics and Novartis. His roles progressed from scientist to senior director including positions in quality control, analytical development and pharmaceutics. After serving as acting COO at an instrumentation start-up Infrasign, he joined Algenol Biofuels as Senior Director of Analytics and Bioinformatics and at Synthetic Genomics heading analytical chemistry and quality.
