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Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.
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Introduction to cGMPs

This course describes the importance and purpose of Good Manufacturing Practices (cGMPs) that ensure safe manufacturing of pharmaceutical products and medical devices as well as enforcement by FDA.

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Description

Current Good Manufacturing Practices (cGMPs) are specific requirements that help ensure safer manufacturing of pharmaceutical products and medical devices. This course describes the importance, purpose and enforcement of cGMPs by the U.S. FDA. Topics in this course include history, key subparts of the pharmaceutical regulation, procedures, documentation and data integrity, quality system, responsibilities and FDA inspections. After completing this course, learners will be able to recognize basic cGMP requirements and identify the roles and responsibilities of pharmaceutical and medical device manufacturing employees.

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Duration

45 minutes

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Library

Medical Device GMPs, Pharmaceutical GMPs

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Functional area

GMP Basics and Core

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