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COURSE ID 3

GMP Professional Certification

AVAILABLE On-demand
15 Hours

On-Demand

Offering Price

Last Registration Date
March 28, 2023.

$ 2395
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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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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 - 1.5 COBBLESTONE
View Course Outline

The GMP Professional Certification Program will provide the necessary orientation and understanding of the USA FDA’s Current Good Manufacturing Practice for pharmaceutical products.
The certification program will cover techniques and practices to ensure compliance with these regulations including manufacturing, packaging, holding, distribution and the laboratory. It will provide a practical application of the cGMP on the operating level.

who should
attend?

LEVEL
Intermediate
INTERESTS
Biotechnology / Biopharmaceutical Pharmaceutical Science & Technology

The GMP Professional Certification will be valuable to 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
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.

Course Included

21 CFR 211 Subparts A & B: Quality and Personnel

90 Minutes

21 CFR 211 Subparts C & D: Facility and Equipment

90 Minutes

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

90 Minutes

21 CFR 211 Subparts G & H: Packaging, Labeling and Distribution

90 Minutes

21 CFR 211 Subparts I: Laboratory Controls

90 Minutes

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

90 Minutes

FDA Quality Systems Guideline

90 Minutes

cGMP Compliance and non-Compliance

90 Minutes

cGMP Compliance: and Process Validation

90 Minutes