21 CFR 211 Subparts J & K: Records and Salvaged Drug Product

Part of the 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 the FDA regulations 21 CFR Subparts J&K addressing the words and meaning as they apply to the US Pharmaceutical Industry. The course will show how these paragraphs are to 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
  • Identify the importance of records
  • Show how the regulations affect you and your job function
  • Explain the importance of sampling, testing, and release
  • Illustrate the consequences of not complying
  • Show logically the best GMP approach
  • Identify that there are more than just the USA regulations
  • Analyze OOS and Deviations
  • 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 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

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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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