Scope of the FDA: History and FDA Regulations

Part of the Cobblestone 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 standard for ensuring pharmaceutical quality are the Current Good Manufacturing Practice (cGMPs) regulations.

This course will discuss the background of the cGMPs and their applicability to the pharmaceutical industry. The course will also cover how the cGMPs are enforced by FDA and how companies should work to comply with them.

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

  • Outline the regulationsto properly comply
  • Contrast and summarize current regulations and guidelines
  • Outline how the regulations affect you and your job function
  • Comprehend the meaning of “c” in cGMP
  • Explain why and how regulations came about
  • Show what pharmaceutical product types are affected
  • Explain to Management who have the Oversight of GMP and GDP Compliance

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
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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