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Wednesday, March 20, 2019
Home » 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection

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

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

Availability: Immediately available upon ordering.

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

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 BioPharma Institute

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 BioPharma Institute 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) 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 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection course is found in the following professional certification program(s):


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.

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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