GMP in a Nutshell

AVAILABLE ON-DEMAND

Duration: 90 Minutes

Course Instructor

Charity Ogunsanya

Accreditation

0.2 CEUs

IACET

Price

$ 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 is the Current Good Manufacturing Practice (cGMPs) regulation for human pharmaceuticals.While drugs represent only one third of the Food, Drug and Cosmetic Act, drugs are impacted by some of the most stringent FDA requirements known collectively as GMPs. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs.

This accredited training session discusses some facts that may be helpful in understanding how cGMPs per 21 CFR Part 210 and 211 establish the foundation for drug product quality and how it provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

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

Describe the origin of the FDA and cGMP
Describe the basic principles of cGMPs, enforcement authority and the need to comply
Explain the “Fundamentals”, “Benefits” and “Key Parts” of cGMPs
Apply the detailed regulatory requirements guiding cGMP (21 CFR 211)
Apply cGMP in the manufacture of quality products

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Who should
attend?

LEVEL

Introductory

INTERESTS

Biotechnology / Biopharmaceutical Cosmetics / Personal Care & Skin Care Medical Devices / Diagnostics Pharmaceutical Science & Technology

This online training will benefit professionals in the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Industries.

The training will be especially beneficial to personnel and management in the following areas and positions: QA/QC, Laboratory, Testing Analysts, Manufacturing, Suppliers, Vendors, Validation, Supplier QA, Regulatory Affairs, Shipping and Receiving, Facility and Maintenance, Microbiologists, Engineers and Materials Management.

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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