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Wednesday, April 26, 2017
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21 CFR Part 820: cGMP System Regulation (EMDUSP01)

Certification Training Duration: 1 hours (the average time to complete the training program, including final assessments).
Credits Hours: 1
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $95.00

BioPharma Institute LogoTraining Program: 21 CFR Part 820: cGMP System Regulation
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. 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.Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The 21 CFR Part 820: cGMP System Regulation Course is Found in the Following Professional Certification Program(s):


Employee cGMP for Medical Devices Professional Certification Program:For those working in the medical device manufacturing industry.

COURSE OUTLINE:


COURSE OBJECTIVES:


The objective for this training is to provide the learner with a deeper knowledge within this subject matter.


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 Support@BioPharmaInstitute.com.

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