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Wednesday, April 26, 2017
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Employee cGMP for Medical Devices Professional Certification Program (E1GMPMD)

Certification Training Duration: 5.5 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 $549.00

Description: For those working in the medical device manufacturing industry.
Training Provided By: BioPharma Institute

BioPharma Institute LogoThe Employee cGMP for Medical Devices Professional Certification Program Includes the Following Individual Courses:

GMP: Contamination Control for Employees: This topic discusses the sources of contamination and methods of preventing contaminating products. This is a great session for new employees, or as part of a preventive action as a result of contamination control breaches.

GMP: Proper Documentation Practices: This topic reviews the proper procedure for entering information into GMP documents, correcting errors in documents and highlights numerous acceptable documentation practices. This is a great class for new employees or others who need to review GMP documentation. It also serves as a retraining component as a part of a preventive action in response to a documentation deviation.

GMP: Root Cause Analysis: Having trouble resolving deviations? This topic reviews a successful model for investigating and identifying the root cause of deviations. This is a great review if you are considering our on site class on Root Cause Analysis.

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.

GMP: Surviving an FDA Inspection: Learn what to expect, how to plan for an inspection, how to behave. This program has demonstrations of interviews and different response strategies.

GMP: Understanding Validation: Delve into the intricate rules and practices of validation. This course is based on the 2008 guidance document on validation.

For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email

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