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Wednesday, April 26, 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:

Technology is playing a significant role in compliance than ever before. That’s why proper preparation and presentation of electronic signatures and electronic records must be done in accordance to 21 CFR Part 11, an FDA regulation. The 21 CFR Part 11: Auditing for Part 11 Compliance Course will teach students what inspectors and auditors look out for during inspections. You are required to pass an online, multiple-choice final assessment after completing the theory phase of the course.

Benefits of Getting Certified at BioPharma Institute

Throughout each course, students will engage in active learning with the aid of tools such as live and recorded seminars, high-quality animations and videos, online books, and more. At BioPharma Institute, we cater to both small-scale and large-scale training requests. Our online training solutions can be customized based on your unique requirements.

Since our inception, we have been one of the top online training institutes for professionals working in the pharma, biotech, and healthcare industry. We have assisted thousands of businesses to train their employees, including corporations such as Gyrus Medical, InSightec, 3M, and more. You can rest assured that our certifications are recognized by a wide spectrum of industries as well.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at for more information.

21 CFR Part 11: Compliance for Electronic Medical Records:

The 21 CFR Part 11: Compliance for Electronic Medical Records is one of the training components of the Electronic Signatures & Records Professional Certification Program. The use and storage of medical records has drawn a huge debate from many stakeholders in the recent past, with issues such how these records should be assessed taking center-stage. This course provides an overview of the FDA guidelines that generally regulate the storage and use of medical records. Once completed, the students are assessed using a multiple-choice examination and a passing grade of at least 80% is required. The test can be taken with an unlimited number of tries.

Benefits of Getting Certified at BioPharma Institute

Stellar online pharma training courses recognized by major players in various industries are hard to come by, and BioPharma Institute is one of the top providers of such courses. For over two decades, we have been catering to the training needs of both large corporations and small businesses when it comes to keeping them updated about FDA regulations and compliance standards in the biotech, pharma, and healthcare industries.

BioPharma Institute’s training courses are suitable for industry veterans who are interested in upgrading their skills, as well as individuals who are being introduced into their new job scopes for the first time. We make learning easy by use of a variety of media including high definition animations, books, voiceovers, and more. When you choose our institute, you are guaranteed an excellent education delivered through a convenient method.

Have Questions?

If you are interested in any aspect of this course, feel free to contact us at (888) 424-6576 or send us an email at for more information.

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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