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What is Process Validation Report | 21CFR11 Compliance Checklist 2018

Added by globalcompliancepanel on 2017-11-19

Conference Dates:

Start Date Start Date: 2018-01-11
Last Date Last Day: 2018-01-12
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2018-01-09

Conference Contact Info:

Contact Person Contact Person: Event manager
Email Email:
Address Address: Germany, Germany, Germany
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


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 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

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


Medical Device
Radiological Health
Blood Products
Companion Animals


Day 1 Schedule

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 Specifications
Software Configuration and Build
Exercise on how to create Design Specifications

Day 2 Schedule

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
o Test Reports
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

Angela Bazigos
CEO, Touchstone Technologies Silicon Valley

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer,, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA 6EBD46C58CDC43A8B7773095.ashx. Patent on speeding up software compliance . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom 015/07/24/using-training-to-bring-compli ance-to-boardrooms/. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences: zigos.7144112.html#overview.

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