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Excel Spreadsheet and FDA Device Regulations (ESR02)

Certification Training Duration: 1.3 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 $125.00 LogoTraining Program: Excel Spreadsheet and FDA Device Regulations
Training Provided By:

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

As part of the Electronic Signatures & Records Professional Certification Program, the Excel Spreadsheet and FDA Device Regulations Course helps individuals prepare better for FDA inspections. It reviews the importance of proper documentation, approval, and validation of Excel spreadsheets so that an organization can avoid violating the QSR requirements for automated processes and creating any problems during an FDA inspection. The course also consists of a multiple-choice final assessment where an 80% passing grade is required. Students will receive a certificate upon course completion.

Benefits of Getting Certified at

We are a leading online training institute for professionals working in the healthcare, biotech, and pharma industry. For more than 20 years, we have aided thousands of businesses in training their employees. Our certifications are recognized by a wide range of companies, and we can customize our training solutions to most organization’s needs.

The capabilities of our eLearning system are remarkable, and make online learning a breeze. Students will learn the essentials of each topic via different educational tools, such as online books, live and recorded seminars, voice-overs, and more. Whether your organization needs to run a course or program for new or seasoned employees, is able to deliver high quality training for you and your colleagues.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.

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 Excel Spreadsheet and FDA Device Regulations Course is Found in the Following Professional Certification Program(s):

Electronic Signatures & Records Professional Certification Program: The Electronic Signatures & Records Professional Certification Program covers six areas of training, including compliance for electronic medical records, auditing for Part 11 compliance, proper procedures to pr … Learn more


-Overview of the regulations (Automated processes, Production and process changes, General record keeping requirements, Electronic records).
-Excel Validation.
-Setting the validation criteria.
-Developing an input message.
-Developing an error warning message.
-Using the Excel Convert Function.
-Changing the unit of measure.
-Excel Formula Auditing.
-Excel Protection.
-Understanding automated process.
-The regulation (The concept of validation, Establishing intended use, Establishing the validation protocol).
-The guidance document.
-How much validation evidence is needed?
-Defined user requirements.
-Validation of off-the-shelf software and automated equipment.
-Electronic records.
-General requirements for records.
-Definitions from Part 11 (Electronic records, Closed systems, Open systems).
-Summary of requirements (Validation, System access, Audit trail).
-The guidance document. Enforcement discretion.
-Electronic record.


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


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