IQ/OQ/PQ

The Installation/Operational/Performance Qualification of equipment, systems and facilities for sterile, oral solid dosage forms, liquids, finished and bulk drugs in the Pharmaceutical and Bio Pharmaceutical manufacturing operations are essential parts of the overall validation process. Equipment and systems must be installed, operated, and maintained within design specifications and facilities must be accepted as fit for use. Lastly, processes must be shown to be reliable and robust to assure the consistent quality and integrity of the final product. This 12-hour accredited training provides a basic and thorough understanding of preparing, executing, reviewing, and approving qualification protocols. A Risk Based approach to impact critically assessment is also provided along with an overview of ICH Q9 Quality Risk Management and ASTM E 2500 approaches now being applied by the industry. Though no library of completed protocols will be provided, examples and workshops will be utilized to enhance learning.