cGMP Compliance: Process Validation

Part of the Cobblestone GMP Professional Certification Program

Duration: 90 Minutes
Course Instructor

Louis Angelucci

$ 195
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

Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current Good Manufacturing Practice (cGMPs) regulations.

This course will discuss compliance to the FDA guide on process validation providing an explanation of the concepts and meaning as they apply to the USA Pharmaceutical Industry. The course will explain aspects of compliance to the guideline.

Upon completion of this course, you will be able to:

  • Analyze the guideline in order to properly comply
  • Identify and discuss current process validation requirements
  • Explain how the Guideline affects you and your job function
  • Explain the meaning of PPQ and CPV
  • Show the consequences of not complying
  • Show logically the best GMP approach
  • Identify differences in the performance of Process Validation
  • Outline how to apply these definitions to a product
  • Illustrate that how you perform and what you make affects the health of many

This training is part of the 10-course series required for the Cobblestone GMP Professional Certification Program. Attend this as a step in the certification process or as a stand-alone course for personal career advancement and training.

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This course has been developed to meet the training needs of professionals in the Pharmaceutical, Medical Device and Cosmetic Industries. It will be especially valuable to those engaged in compliance with FDA regulations, Compliance, QA/QC, Formulation, Production, Manufacturing and Regulatory areas.

Engineers, chemists, QA/QC and manufacturing personnel will benefit greatly by attending this course by understanding the extent of the FDA regulations and how they affect daily job responsibilities.

Course Instructor


Louis Angelucci

Consultant for the Pharmaceutical Industry

Louis Angelucci’s Courses
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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.

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