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2day Inperson seminar on Computer System Validation Reduce Costs and Avoid 483s At Chicago IL

2/6/2014 9:00 AM - 2/7/2014 6:00 PM


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. The latter impact all areas of ICH Q9 and ICH Q10. 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 and, 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.

In this Seminar attendees will learn:

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:

CSV in the Life Sciences Industry: What it is, where to find requirements in other guidances including 21 CFR 11 & Annex 11, how it fits in with ICH Q9 and ICH Q10?

How to implement CSV

How Cloud, Patient Confidentiality are impacted

CSV & Business Continuity

How to have a successful FDA inspection

483s & Warning Letters and how to respond to CSV related citations

Course Outline:

Day 1 – Agenda

Lecture 1: Introduction / Background

Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)

Overview of Life Sciences Lifecycle (ICH Q10) and how CSV fits into it

Detecting CSV in predicate rules / guidances

CSV in 21 CFR 11 / Annex 11

The FDA, s 21 CFR 11 Add-On Inspections

Lecture 2: CSV at a High Level

CSV: It's Easy!! Really!!

CSV components and deliverables

CSV & ICH Q9 (Risk Assessment)

Lecture 3: CSV Detailed Study

Validation Plan

Requirements Specifications

Functional Specifications

Exercise on how to create requirements

Day 2 – Agenda

Lecture 4: CSV Detailed Study (Cont'd)

Design Specifications

Software Configuration and Build

Traceability Matrix

Verification and Testing

Validation Report

Validation Registry

CSV for Excel and other spreadsheets

Lecture 5: CSV implementation in Cloud

Regulatory Compliance for the Cloud

Lecture 6: Business Continuity

Implementing Business Continuity for CSV

Lecture 7: Project Management & QA

Project Management for CSV

How to audit CSV projects

Lecture 8: 483s & Warning Letters

What are 483s & Warning Letters (and other Regulatory Citations)

How to Respond to CSV related citations following an inspection

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






Angela Bazigos

CEO, Touchstone Technologies Silicon Valley

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences 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 Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations 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.

Location1: Chicago IL| 06th & 07th, February 2014| 9:00 AM- 6:00PM EST

Venue: Courtyard Chicago Downtown/River North

Price: $1,295.00


Register now and save $200. (Early Bird)

Until January 20, Early Bird Price: $1,295.00

from January 21 to February04, Regular Price: $1,495.00

Address: 30 East Hubbard Chicago, Illinois 60611 USA

Location2: Los Angeles CA |20th & 21st March 2014| 9:00 AM- 6:00PM PDT


Price: $1,295.00


Register now and save $200. (Early Bird)

Until February25, Early Bird Price: $1,295.00

from February26 to March18, Regular Price: $1,495.00

Contact Information:

Event Coordinator

Phone: 1800 447 9407

Fax: 302-288-6884




Event Link:

NetZealous LLC,

DBA GlobalCompliancePanel,

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

Phone: 1800 447 9407

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