Describe A Quality System Model Focusing On The Management Responsibilities, Resources, Manufacturing Operations
Jan 27, 2022
Describe a quality system model focusing on the management responsibilities, resources, manufacturing operations, and evaluation activities, and how they relate to GMPs.
Describe the classic V-Model and how it aligns testing activities to specification documents, to confirm that the equipment being validated is fit-for-purpose
Describe why regulatory audits inspect GMP requirements for Validation within pharmaceutical manufacturers and detail the typical documentation that will be required for such an inspection
Describe the characteristics of GMP that are embedded in the rules, regulations, and guidelines of the manufacturing process for a typical chemically derived Active Pharmaceutical Ingredients, OR for a typical Biopharmaceutical Protein Therapeutics, OR for a typical Medical Device
Describe the methodologies to generate, store and distribute purified water, and their relationship to the GMPs for manufacturing safe medicines, vaccines, or medical devices.