How to prepare and host an FDA inspection
21 CFR Part 11: how to successfully prepare for and host an FDA inspection
Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.
Why should you attend:
More and more organisations are striving to "go green" and develop "sustainable" organisation's strategies, which almost always includes using more and more of the computer technologies. Part 11 is a regulation that regulates the technology when it comes to electronic signatures and electronic records and will be more then ever a part of the scope of the FDA inspections, yet most organisation do not know how to best prepare for such inspections.
In a time of global economy when and where time is of essence, having an ability to access records from any location around the world is more critical then ever, and for the same reason, electronic records will be more needed and desired in each organisation. In addition, approval of documents and records in a timely fashion is absolutely needed at all times, and being able to do just that via an electronic media is understood. For both, electronic signatures and electronic records, the organisation shall comply with the Part 11 regulation.
Areas covered in the session:
Short and quick overview of the Part 11 regulation
Detailed description of how to prepare for an FDA inspection
When and Where Part 11 is in scope or the scope of the inspection;
Detailed description of how to handle the FDA inspection during the inspection itself;
Some trends when it comes to Part 11 inspections;
Commonly asked questions; warning letters examples; and what the future holds when it comes to Part 11.
Who will benefit:
Quality managers
Quality engineers
Small business owners
Internal and external auditors
Management reps
FDA inspectors
Consultants
Jasmin NUHIC 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. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation.
Date: 19 September 2012Time: 10:00 - 12:00
Venue: Online Training, Wilmington
Cost: $295.00
More info:
Online training