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Wednesday, March 20, 2019
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Excel Spreadsheet and FDA Device Regulations (ESR02)

Certification Training
Duration: 1.3 hours, Online (the average time to complete the training program, including final assessments).
Credits Hours: 1
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: Excel Spreadsheet and FDA Device Regulations
Training Provided By: BioPharma Institute

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute Reviews

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 BioPharma Institute

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, BioPharma Institute 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) 424-6576 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.

The Excel Spreadsheet and FDA Device Regulations course is found in the following professional certification program(s):


-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.

Online Training Program Benefits:

  • Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization

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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