21 CFR 211 Subparts C & D: Facility and Equipment

Part of the GMP Professional Certification Program

Duration: 90 Minutes
Course Instructor

Louis Angelucci

$ 295
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 standards for ensuring pharmaceutical quality are the Current Good Manufacturing Practice (cGMPs) regulations.

This accredited course will discuss the FDA regulations 21 CFR 211 Subparts C & D addressing their words and meaning as they apply to the US Pharmaceutical Industry. The course will show how these paragraphs should be interpreted and how one should comply.

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

  • Outline the regulations in order to properly comply
  • Explain how properly designed and clean equipment is critical to GMP
  • Illustrate that how you perform and what you make affects the health of many
  • Classify how the segregation of functions and activities prevents cross-contamination
  • Show how a clean and compliant facility is crucial to drug quality
  • Explain the consequences of not complying

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 greatly benefit from attending this course by understanding the extent of FDA regulations and how they affect daily job responsibilities.

Course Instructor

Louis Angelucci

Consultant for the Pharmaceutical Industry

Louis Angelucci’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.

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