Seminar · Washington, District of Columbia
2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance
Health · Medicine · Physicians
Key numbers
- Editions on record
- 1first in 2014
About 2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance
Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.
This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools
The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system
From our listing of this edition. Details may have changed since.
Editions
| Year | Dates | Where | Exhibitors | Visitors |
|---|---|---|---|---|
| 2014 | 11–12 Sep 2014 | Hilton Garden Inn Washington DC Downtown Washington, District of Columbia | — | — |
Past editions from the bvents archive (2008–2019) and organiser figures where they were published.
Questions
When is 2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance?
The next dates haven't been confirmed. The last edition we have on record was 11–12 Sep 2014.
Where is it held?
The last edition we have was at Hilton Garden Inn Washington DC Downtown, Washington, District of Columbia.