Complying with GMPs for Clinical Manufacturing
Course Description
Compliance with the FDA's GMPs during clinical supply manufacturing presents unique challenges not typically associated with commercial manufacturing. It is critical to be able to overcome these challenges successfully, as non-compliance during the clinical stage can lead to approval delays and/or enforcement actions. Also, patient safety can be jeopardized if clinical trial material is not produced to regulatory standards! This introductory to intermediate-level training course provides a step-by-step foundation for GMP compliance for clinical manufacturing. The course begins by reviewing GMP regulations and highlighting the key differences between clinical supply manufacturing and commercial manufacturing. Up-to-date FDA requirements are discussed for planning and development, production and quality control. Facility and maintenance, IQ/OQ/PQ standards, protocols and process plans, stability tests and batch record requirements are examined. In addition, strategies to prevent cross-contamination while streamlining the clinical supply process are provided. Throughout the course, interactive discussions and exercises will solidify core concepts.