ISPE CEUs: 1.3
Type: Classroom Training Course
Biotech and pharmaceutical companies that manufacture active pharmaceutical ingredients (APIs) face a host of compliance issues unique to their processes. This course reviews and interprets the key GMP requirements specific to bulk biopharmaceuticals and familiarizes participants with the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
This course will cover areas in which compliance requirements differ most from traditional pharmaceuticals and biologics, and will review common deficiencies and problem areas related to Q7A. There will be a particular focus on equipment and engineering, and Q7 compliance issues, with recommended systems, controls, and procedures to avoid pitfalls. The course focuses on building solid GMP principles based on the concepts of quality assurance and using sound, scientific principles to build compliant systems. Participants will learn basic regulation information and practical utilization techniques. They will develop the ability to ask the right questions based upon science and the regulations knowing the relationship between this quality guidance for the production of APIs, and the good manufacturing practice (GMP) regulations applicable to the production of pharmaceutical and biologic finished drug products. We recommend participants have a basic understanding of the GMP regulations.
This training course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients Community of Practice (COP).
ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.