COURSE ID 3096

21 CFR 211 Subparts I: Laboratory Controls

Part of the GMP Professional Certification Program

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Louis Angelucci

Price
$ 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 211 Subpart I addressing their 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
  • Explain the importance of packaging and labeling
  • Explain the importance of proper storage and distribution
  • Identify how the regulations affect you and your job function
  • Illustrate that how you perform and what you make affects the health of many
  • Show how the segregation of materials and proper storage prevents cross contamination
  • Summarize how controlled and qualified distribution is critical to potential recall
  • 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

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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