This course provides a basic understanding of the validation process as required by the Food and Drug Administration of the United States for drugs manufactured in the United States and all imported drugs. This course also reviews applicable definitions and descriptions of the process and documents required in the validation of a facility. The process of validation is explained along with the intent of the validation effort. Relationships between types of protocols and other documents which occur at the same time during the construction and startup of a pharmaceutical facility are explored. The final results of the validation process are described and how the effort is prepared for an FDA inspection is touched on. Pharmaceutical Validation Process is ideal for the following professionals: After completing Pharmaceutical Validation Process, students will be equipped with a basic understanding of the following: No prior experience or coursework required. Students will be assigned 5 homework assignments, and 1 final exam. Introduction to Pharmaceutical Validation Process validation Design qualification (DQ) Installation qualification (IQ) Operational qualification (OQ) Process performance qualification (PQ) Analytical validation Equipment validation Process validation of following formulations Computer System Validation This course is Instructor-led and delivered through our award-winning online Learning Management System.
Prospective validation
Retrospective validation
Concurrent validation
General principles of analytical method validation
Validation of following analytical instruments
– HPLC
– Dissolution test apparatus
– U.V./Visible spectrophotometers
– Dry Powder Mixers
– Fluid Bed and Tray dryers.
– Tablet Compression M/c.
– Dry Heat Sterilization/Tunnels
– Autoclaves
– Capsule filling machines.
– Validation of Integrated lines by media fill test.
– Validation of existing equipment.
– Coated tablets
– Capsules
– Ampoules & Vials
– Ointment/Creams
– Liquid Orals