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Thursday, March 23, 2017
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Electronic Signatures & Records Professional Certification Program (ESR001S)

Certification Training Duration: 8.8 hours (the average time to complete the training program, including final assessments).
Credits Hours: 9
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $875.00

Description: This professional certification program details electronic signatures and records (21 CFR Part 11), excel spreadsheet and FDA device regulations, audit trails, how to successfully prepare for and host an FDA inspection, and more.
Training Provided By: BioPharma Institute

BioPharma Institute LogoThe Electronic Signatures & Records Professional Certification Program Includes the Following Individual Courses:

Electronic Signatures & Records – 21 CFR Part 11: In 1997 the FDA gave the Industry the set of rules for electronic signatures and electronic records. It became 21 CFR Part 11: Electronic Signatures, Electronic Records. This course discusses why Title 21 of Code of Federal Regulations Part 11, or ’21 CFR Part 11′ was developed, the role Part 11 plays in the adherence to other sections of 21 CFR, and explores the general concepts of security in a Part 11 compliant system.

Excel Spreadsheet and FDA Device Regulations: FDA Inspections are based on ensuring compliance with the regulations. Failure to comply can result in the FDA citing the company for a violation, i.e., listing it on an FDA Form 483 Inspectional Observations. The FDA may even escalate these observations to a Warning Letter. For example- a manufacturing engineer may recognize that an Excel spreadsheet could reduce the possibility of error in a manual calculation. On its own, the spreadsheet would be a valuable Preventive Action. However if the spreadsheet is not validated, approved, and documented properly it may create a problem during an FDA inspection. An invalidated spreadsheet violates the QSR requirements for automated processes.

21 CFR Part 11: Ins and Outs of Audit Trails: This 21 CFR Part 11 training will provide types of audit trails and Strategies of implementing compliant audit trails as per 21 CFR Part 11 regulations.

21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection: This course will provide valuable assistance to all regulated companies that have or going to implement 21 CFR Part 11 systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, Biologics, Software fields. The employees who will benefit include:

21 CFR Part 11: Auditing for Part 11 Compliance: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records which is applicable to all industries including medical device and pharmaceuticals. Auditors and inspectors have started focusing more and more in this area as technology plays more significant role in compliance then ever before.

21 CFR Part 11: Compliance for Electronic Medical Records: FDA regulations governing electronic records and electronic signatures will be enforced upon these systems as they are used and become more prevalent. This presentation analyzes the regulations and provides concrete guidance on compliance.

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