Validation and 21 CFR Part 11 Compliance of Computer Systems 2014 is a seminar that covers topics such as:
Current Status of 21 CFR 11
History of 21 CFR 11
21 CFR 11.10 (a)-(k)
21 CFR 11 Overview
21 CFR 11.50
21 CFR 11.30
21 CFR 11.100
21 CFR 11.70
21 CFR 11.300
21 CFR 11.200
FDA`s Add-On Inspections for 21 CFR 11
The FDA`s Requirements for 21 CFR 11
Vendor Audit
Risk Assessment
Requirements Specification
Validation Plan
Installation Qualification (IQ)
Design Specification
Performance Qualification (PQ)
Operational Qualification (OQ)
Validation Summary Report
Traceability Matrix
SOPs
Validation Registry
Create ALL Deliverables for a Laboratory Information Management System (LIMS)
21 CFR 11 Audit
Jeopardy - Test Your Knowledge
Validation and 21 CFR Part 11 Compliance of Computer Systems 2014 is intended for:
IT managers and staff
Attendees using computers in FDA or regulated environments
Regulatory affairs
QA managers and personnel
Consultants
Training departments
Project Managers
Validation specialists
Attendees dealing with electronic records and/or electronic signatures
Vendors of COTS (Commercial Off The Shelf) systems in regulated industries
Past Events
Validation and 21 CFR Part 11 Compliance of Computer Systems - 2020, (78593)
Validation and 21 CFR Part 11 Compliance of Computer Systems 2019 - 2019, (73482)
Validation and 21 CFR Part 11 Compliance of Computer Systems 2018 - 04-05 Oct 2018, DoubleTree by Hilton Philadelphia Airport, Pennsylvania, United States (78592)
Validation and 21 CFR Part 11 Compliance of Computer Systems 2018 - 01-02 Mar 2018, Four Points by Sheraton Boston Logan Airport Revere, Massachusetts, United States (73481)
Validation and 21 CFR Part 11 Compliance of Computer Systems 2018 - 08-09 Jan 2018, Hilton Zurich Airport, Switzerland (72447)
Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advance 2015 - 03-04 Sep 2015, Courtyard Washington Capitol Hill/Navy Yard, District of Columbia, United States (53734)
Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced 2014 - 11-12 Sep 2014, Hilton Garden Inn Washington DC Downtown, District of Columbia, United States (46638)
Validation and 21 CFR Part 11 Compliance of Computer Systems 2014 - 24-25 Jul 2014, DoubleTree by Hilton Hotel San Francisco Airport, Burlingame, California, United States (45771)
Validation and 21 CFR Part 11 Compliance of Computer Systems 2014 - 06 Jun 2014, The LaLit Mumbai, India (45367)
Validation and 21 CFR Part 11 Compliance of Computer Systems 2014 - 29-30 May 2014, Hilton Sydney, Australia (44714)
Validation and 21 CFR Part 11 Compliance of Computer Systems 2014 - 22-23 May 2014, Hilton Zurich Airport, Switzerland (44716)
Validation and 21 CFR Part 11 Compliance of Computer Systems 2014 - 07-08 Apr 2014, Mandarin Orchard Singapore (43463)
Important
Please, check "Validation and 21 CFR Part 11 Compliance of Computer Systems" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Healthcare, Hospitals & Clinics, Internal medicine, Medical device, Medical laboratories, Medical technology, Pharma
