21 CFR Part 11: Ins and Outs of Audit Trails

Instructor: Jasmin NUHIC
Product ID: 701612
Training Level: Intermediate to Advanced
  • Duration: 75 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2010

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

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Read Frequently Asked Questions

This 21 CFR Part 11 training will provide types of audit trails and Strategies of implementing compliant audit trails as per 21 CFR Part 11 regulations.

Why Should You Attend:
21 CFR Part 11 is the FDA regulation for electronic signatures and electronic records. It started by the pharma and is a good regulation for medical and pharma companies but also a good guideline for other industries. Audit trails are major requirement for many software applications regardless of an industry or users. This is especially true when it comes for Pharma and medical devices companies and other businesses that have implemented or are planning on implementing 21 CFR Part 11 and striving to comply with the same regulation.

Attend this Webinar to increase understanding of the Part 11 regulations; improve compliance and meeting the regulations when it comes to different types of audit trails. In this Webinar the different types of audit trails will be discussed along with pros and cons, how audit trail can be used as an effective audit tool.

Areas Covered in the Seminar:

  • Subsection of Part 11 and Interpretation of the subsection.
  • Types of audit trails and Strategies of implementing compliant audit trails.
  • Audit Trail Pros and Cons.
  • Audit Trail As an Auditing Tool.
  • Audit Trail Shoulds and Shouldn’ts.
  • What if’s?
  • Commonly asked questions about Audit Trail.
  • What is next about 21 CFR Part 11.

Related Technical Document:

Will provide 30+ commonly asked questions; 21 CFR Part 11 regulation; Sample internal/external audit/inspection checklist based on 21 CFR Part 11 regulation.

Who Will Benefit:

  • Quality Managers
  • Quality auditors
  • Small business owners
  • CAPA investigators
  • FDA inspectors
  • Software engineers and developers
  • Consultants

Instructor Profile:
Jasmin NUHIC, serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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