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Tuesday, June 27, 2017
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21 CFR Part 11: Auditing for Part 11 Compliance (ESR06)

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: Auditing for Part 11 Compliance
Training Provided By:

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

Technology is playing a more significant role in compliance than ever before. This is why proper preparation and documentation 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. To receive your certification, learners are required to pass an online, multiple-choice final assessment after completing the presentation phase of the course.

Benefits of Getting Certified at

Throughout each course, students will engage in active learning with the aid of tools, such as recorded webinars, high-quality animations, videos, online books, and more. At, 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. You can rest assured that our certifications are recognized by a wide spectrum of companies, in a variety of industries.

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: Auditing for Part 11 Compliance 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.
– Planning fo audits
– Tools for successful audit.
– Preparing for the audit.
– Executing the audit.
– CAPA and close of the audit.
– What to expect for responses.
– Common audit findings
– Common pitfalls.


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


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