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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 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.
Upon completion of this course, you will be able to:
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This introductory/intermediate course is designed for individuals who need a basic, but thorough understanding of the Installation/Operational/Performance Qualification Process for equipment and systems in support of Process Validation for the manufacture of regulated products.
The course will benefit individuals in:
Managers and supervisors of the above-listed individuals would also benefit from this training by becoming acquainted with the challenges and timelines for proper qualification.
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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.Learn more
Quality Management and Compliance in the Pharmaceutical and Related Industries
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