2-day In-person Seminar on “Validation and 21 CFR Part 11 Compliance of Computer Systems” at Sydney

Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry .

29-30 May 2014 at Sydney, Australia

Medical & Health Care, Pharmaceuticals/Drug Discovery

2-day In-person Seminar on “Validation and 21 CFR Part 11 Compliance of Computer Systems” at Sydney 29-30 May 2014 Sydney, Australia
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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.

Consequently, the number of 483s / Warning Letters due to CSV continue to be on the rise. It is estimated that 1 in 5 of Medical Device Recalls are due to incorrect CSV. Currently, there are many outstanding Official Actions by Regulatory Authorities (e.g. 483s, Warning Letters, etc.) that include citations for CSV. This is expected to further escalate as technology advances and companies need to consider Cloud Technologies, as well as patient privacy issues such as HIPAA
Costs of not understanding CSV are enormous: One 2013 incorrect implementation of CSV resulted in fines of up to $3Billion. Software Projects requiring CSV often overrun by several months. Corrections to a CSV 483 can result in costs of $250,000 and often multiple issues are found. More importantly, CSV is a foundation to other discovery, development & commercialization of products and CSV failure includes failure of those efforts.

The Seminar:
This Hands-On course will provide the attendees with both a strategic and a tactical understanding of how CSV fits into all aspects of the Life Sciences Industry and how to implement CSV to ensure successful inspections. It will address the following topics:
1. What is 21 CFR 11 and Computer Systems Validation
2. The FDA's perspective (also, other regulatory agencies)
3. How to implement 21 CFR 11 and Computer Systems Validation
4. Special Topics: Excel, Cloud and Business Continuity
5. Project Management for 21 CFR 11
6. Quality Assurance for 21 CFR 11

Who Should Attend?
1. VP of IT
2. Director of IT
3. Quality Managers
4. Project Managers (for CSV / IT)
5. Validation Specialists
6. Database Administrators
7. System Administrators
8. Directors / Senior Directors of Discovery
9. Directors / Senior Directors of Development
10. Directors / Senior Directors of Commercialization
11. Document Managers
12. Training Managers

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

Course Outline/Agenda:

Day One:
Lecture 1: Introduction / Background
• Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)
• 21 CFR 11 & CSV - Basic Concepts
• Computer Validation - an FDA Perspective

Lecture 2: CSV at a High Level
• CSV: It's Easy!! Really!!
• CSV components and deliverables
• 21 CFR 11 Jeopardy!!!

Lecture 3: CSV Detailed Study
• Risk Assessment
• Validation Plan
• Requirements Specifications
• Exercise on how to create requirements

Lecture 4: CSV Detailed Study (Cont'd)
• Functional & Design Specifications
• Software Configuration and Build
• Exercise on how to create Design Specifications

Day Two:

Lecture 5: CSV Detailed Study (Cont'd)
• SOPs
• Traceability Matrix
• Verification and Testing
• Exercise Creating Validation Scripts
• Validation Report
• Validation Registry

Lecture 6: Special Topics
• CSV for Excel and other spreadsheets
• Regulatory Compliance for the Cloud
• Implementing Business Continuity for CSV

Lecture 7: Project Management for CSV
• Project Management for CSV
• Selecting software for 21 CFR 11 Compliance

Lecture 8: Quality Assurance for CSV
• How to audit CSV projects

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 assurance and remediation’s following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley's Business School for Executive Education in Life Sciences and on the Stanford Who's Who Registry for contributions to the Life science industry.

Date, Venue and Price:
Location: Sydney, Australia
Date: 29th and 30th May 2014
Venue: Will Be Announced Soon
Price: $1595.00
Discount for One Delegate and Group Participants:
Register now and save $200. (Early Bird)
Until April 30, Early Bird Price: $1,595.00
From May 01 to May 27, Regular Price: $1,795.00

Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com
LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php
NetZealous LLC
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
For More Info Click Here: http://bit.ly/1ikJfqs

From: May 29, 2014 09:00
To: May 30, 2014 18:00

Sydney, Australia


Medical & Health Care, Pharmaceuticals/Drug Discovery


21 CFR Part 11, 21 CFR Part 11 Compliance, CSV Compliance, Compliance Online, Computer Systems Validation, Regulatory Compliance

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