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2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems at Washington DC


2014, September 11 - 12 @ 00:00 - 00:00

Pharmaceutical » Training


The Problem:

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

The Seminar:

This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows:
1. Validation Master Plan
2. Complete Validation for a System
3. Excel Spreadsheet Validation
4. Change Control
5. SOPs
6. Test Tools Validation
7. Project Management for Validation

Course Description:

Day 1 – Agenda

Lecture 1: Introduction / Background
• Introductions / Participants' Understanding
• Participants' Objectives for the Course (Please come prepared to discuss)
Lecture 2: Requirements at a High Level
• Types of Requirements
• Difference between User Requirements & Functional Requirements
Lecture 3: Detailed Requirements Study
• Gathering Requirements
• Entity Relationship Diagram
• Process Decomposition
• Risk Assessment for Requirements
• Exercise on how to create Requirements
Lecture 4: Design
• Design Specifications
• Software Configuration and Build
• Exercise on how to create Design Specifications

Day 2 – Agenda

Lecture 5: CSV Detailed Study (Cont'd)
• Traceability Matrix
• Verification and Testing
• Exercise Creating Validation Scripts
• Exercise Creating Traceability Matrix
Lecture 6: Other Documents
• Validation Plan
• Test Protocols
• Validation Report
• Validation Registry
Lecture 7: Special Topics
• Project Management for CSV
• Infrastructure for CSV
• Selecting software for 21 CFR 11 Compliance
• Test Tools for CSV
Lecture 8: Change Control & Business Continuity
• Change Control
• Implementing Business Continuity for CSV
Who Should Attend?
• VP of IT
• Director of IT
• Quality Managers
• Project Managers (for CSV / IT)
• Validation Specialists
• Database Administrators
• System Administrators
• Directors / Senior Directors of Discovery
• Directors / Senior Directors of Development
• Directors / Senior Directors of Commercialization
• Document Managers
• Training Managers

Industries:

• Pharmaceuticals
• Biotech
• Medical Device
• Radiological Health
• Blood Products
• Companion Animals
• Food
• Cosmetics
• Tobacco
• Academia

Instructor/Speaker Profile:

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.
Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Life sciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality


Venue

Washington DC
United States

Organizer

Global Compliance Panel
Email: webinars@globalcompliancepanel.com
Visit organizer website



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