Louis Angelucci
Earn Your GMP Professional Certification
Cobblestone’s GMP Professional Certification Program will provide you with the necessary orientation and understanding of the USA FDA’s Current Good Manufacturing Practice for pharmaceutical products.
You will be trained in the understanding and interpretation of the FD&C Act, the cGMPs, the FDA Guidance Documents, and FDA’s recent Observations issue in FD 483’s to Pharmaceutical firms.
This 10-part 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.
Upon completion of this Certification, you will be able to:
Courses Included in this Certification:
Scope of the FDA – History and FDA Regulations
21 CFR 211 Subparts A & B: Quality and Personnel
21 CFR 211 Subparts C & D: Facility and Equipment
21 CFR 211 Subparts E & F: Control of Components and Production/Process Control
21 CFR 211 Subparts G & H: Packaging, Labeling and Distribution
21 CFR 211 Subparts I: Laboratory Controls
21 CFR 211 Subparts J &K: Records and Salvaged Drug Product
FDA Quality Systems Guideline
cGMP Compliance and Non-compliance
cGMP Compliance: Process Validation
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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.
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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