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Tuesday, February 21, 2017
Home » Online Training Course

Medical Device cGMPs Professional Certification Program (E1GMPMD)

Certification Training Duration: 4.9 hours (the average time to complete the training program, including final assessments).
Credits Hours: 5
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $489.00


BioPharma Institute LogoThe Medical Device cGMPs Professional Certification Program includes the following individual courses:




21 CFR Part 211: cGMP Regulations and Controls: This topic summarizes the most important elements of 21 CFR Part 211, cGMP Regulations and Controls Used for Manufacturing, Processing, Packing, or Holding Drugs. This is a great orientation to the regulation for new employees or serves as a quick refresher for seasoned employees.

21 CFR Part 211 Subpart B: Organization and Personnel: This topic summarizes the essential elements of 21 CFR 211 subpart B, Organization and Personnel. This is a great orientation to this subpart for new employees or serves as a quick refresher.

21 CFR Part 211 Subpart C: Buildings and Facilities: This topic provides a review of the requirements of Building and Facilities issues well beyond Subpart C, Buildings and Facilities.? This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.

21 CFR Part 211 Subpart D: Equipment: This topic discusses the requirements of 21 CFR 211 Subpart D – Equipment specifically the design and construction requirements for equipment including lubrication and coolants. The class addresses cleaning and maintenance requirements including automatic and electronic equipment. The class also covers the requirements for equipment identification, personnel training and required documentation.

21 CFR Part 211 Subpart E: Materials: This topic traces the GMP requirements from supplier qualification through to manufacturing and packaging. A solid review of 21 CFR 211 Subpart E, Control of Components, Drug Product Containers and Closures.

21 CFR Part 211 Subpart F: Production and Process Controls: This topic provides a review of the requirements of 21 CFR 211 Subpart F, Production and Process Controls.? This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.

21 CFR Part 820: cGMP System Regulation: This topic summarizes the most important elements of 21 CFR 820, Current Good Manufacturing Practice (CGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. This is a great orientation to the regulation for new employees or serves as a quick refresher for seasoned employees. Learn about 21 CFR Part 820 through the eyes of a fictitious medical device manufacturer. Contains live action video from an actual medical device company.


Training Provided By: BioPharma Institute


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