Executing Installation, Operational and Performance Qualifications in Support of Process Validations

Duration: 12 Hours
Course Instructor

Charlie Neal

$ 2330
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

The Installation/Operational/Performance Qualification (IQ/OQ/PQ) 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:

  • Define Validation Master Plans
  • Describe the Impact/Risk Assessment
  • Explain ICH Q9 and the Risk Based Approach
  • Describe the ASTM Standard for Verification
  • Restate the Integrated Commissioning Approach
  • Prepare IQ/OQ/PQ Protocols
  • Execute protocols
  • Write Protocol Summary Reports
  • Describe the Quality Systems necessary to support validation
Register Now

You will be redirected to our secure system.

This introductory/intermediate course is designed for individuals who need a basic, but thorough understanding of the Installation/Operational/Performance Qualification (IQ/OQ/PQ) Process for equipment and systems in support of Process Validation for the manufacture of regulated products.

The course will benefit individuals in:

  • Engineering
  • R&D
  • Technical Services/Validation
  • Regulatory Affairs
  • Quality Control/Assurance
  • Production
  • University and Allied Health Care Professionals

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.

Course Instructor


Charlie Neal

Owner and Senior Consultant for Premier Quality Consulting

Charlie Neal’s Courses


Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

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

We’ve rebranded! CfPA is now COBBLESTONE