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

Instructor: Jasmin NUHIC
Product ID: 701492
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This 21 CFR Part 11, FDA Inspection training/Webinar will discuss how to prepare and host an FDA inspection with 21 CFR part 11 is in the scope of the inspection.

Why Should You Attend:

More and more warning letters are getting issued related to 21 CFR Part 11. The issues related to software validation, audit trails, electronic signatures and electronic records are becoming ever increasing and a lot people are not certain how to tackle them. In addition, when it comes to preparing for and hosting an FDA inspection where 21 CFR Part 11 is part of the scope or the scope itself, most people have no experience or very limited experience - this is primarily due to major difference between this type of inspection and "regular" inspection.

On the other hand as we move forward and continue with the process improvements, it is eminent that we will more and more depend on computer technology to help us. Also, due to economy and travel restrictions access of records is difficult from different locations and subsequent approvals of documents and records are very hard to complete timely. FDA rules and regulations are becoming tighter and the time allowance for responses and submissions (i.e PMA) are getting shorter, which can only be met by implementing electronic signatures and electronic records.

For all of the reason above and more (i.e. company going paperless - green!) compliance with 21 CFR Part 11 is extremely important and the understanding of how to deal with the FDA when it comes to 21 CFR Part 11 is the same.

This Webinar will help you understand what areas are being targeted by the FDA inspectors and what systems are being inspected the most and help you succeed in preparation for and hosting an FDA inspection. Specifically you will learn how to prepare for and host an FDA inspection where and when 21 CFR Part 11 is in scope of the inspection (or the scope itself).

Areas Covered in the seminar:

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

Related Technical Document:

We 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:

This webinar will provide valuable assistance to all regulated companies that have or going to implement 21 CFR Part 11 systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, Biologics, Software fields. The employees who will benefit include:
  • Quality Engineers and Compliance engineers
  • IT software developers and software quality engineers
  • Validations specialist and 21 CFR Part 11 Subject Matter Experts
  • Consultants
  • Quality auditors - internal and supplier
  • End users of the systems which are 21 CFR Part 11 compliant

Instructor Profile:
Jasmin NUHIC, has over 10 years in FDA regulated industry and currently serves a major medical devices OEM as a Sr. Compliance Quality 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.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
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