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21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection (ESR05)

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: 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection
Training Provided By:

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

The 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection Course is one of the courses found in the Electronic Signatures & Records Professional Certification Program. It is recommended for professionals who are working in regulated companies, e.g., in the fields of software, biologics, pharmaceutical, diagnostic, medical device, and more. These companies may be en route or have already implemented 21 CFR Part 11 quality requirement systems.

Benefits of Getting Certified at

If you are looking for online training solutions that are recognized across a wide spectrum of biotech, pharma, and healthcare industries, we are the portal you can trust. For more than 20 years, we have been training employees from both large corporations and small businesses. We cater to all professionals who are looking to refresh or upgrade certain skills.

Our state-of-the-art eLearning platform makes online learning extremely easy through an array of educational tools, including online books, live and recorded seminars, high quality animations, and more. You can rest assured that has stellar resources and industry knowledge to deliver high quality training solutions for both new and seasoned employees.

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 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection 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


About 21 CFR Part 11. Preparing For Inspection. Hosting an Inspection. Warning Letters. FDA inspections Target Areas. Trends. Benefits of Being Compliant.


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


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