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COURSE ID 3094

21 CFR 211 Subparts E & F: Control of Components and Production/Process Control

AVAILABLE On-demand
90 Minutes

On-Demand

Offering Price
$ 295
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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

ACCREDITATION CEU's - 0.2 IACET RAPS
View Course Outline

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.

who should
attend?

LEVEL
Intermediate
INTERESTS
Biotechnology / Biopharmaceutical Pharmaceutical Science & Technology

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 90-minute Accredited Course will discuss the FDA regulations 21 CFR 211 Subparts E & F addressing their words and meaning as they apply to the USA Pharmaceutical Industry. The course will show how these paragraphs are to be interpreted and how one should comply.

This training is one 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.

course instructor

Louis Angelucci
Consultant for the Pharmaceutical Industry

Louis Angelucci’s Courses
Louis Angelucci is a pharmaceutical professional with over 20 years' experience in Quality Assurance, Quality Control, Regulatory Affairs, Validation, consent decree remediation as well as cGMP Compliance in the Medical Device and Pharmaceutical industries. He has worked for several well-known companies including Johnson & Johnson, Bristol-Meyer Squibb, Pfizer, Schering Plough and Merck. His experience has been either as a direct employee or as a contracting consultant while employed at Foster Wheeler and Aker Kvaerner. As a consultant Mr. Angelucci has worked at various project locations domestically and in Europe and Asia. Mr. Angelucci is a degreed engineer with two master's degrees in engineering, holds industry certifications with ASQ as a CQE, CQA and CPGP. He is currently the ASQ Philadelphia chapter Education Chair. In addition, he holds a PMP certification through the Project Management Institute. He has published numerous articles on the subjects of Validation and compliance and has been a speaker to industry groups such as ISPE, IVT, DIA, PDA and ASQ.

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