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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


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:

1. 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

2. How to implement CSV

3. How Cloud, , Patient Confidentiality are impacted

4. CSV & Business Continuity

5. How to have a successful FDA inspection

6. 483s & Warning Letters and how to respond to CSV related citations

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


• Pharmaceuticals

• Biotech

• Medical Device

• Radiological Health

• Blood Products

• Companion Animals

• Food

• Cosmetics

• Tobacco

• Academia

Course Outline:

Day One

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 Two

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

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.

Venue, Address and Date:

Held: 6th & 7th February 2014, Chicago IL

Venue: Will Be Announced Soon

Price: $1295.00 (Seminar for One Delegate)

Discount: Register now and save $200. (Early Bird)

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

From January 21 to February 04, Regular Price: $1,495.00

Contact Information:

John Robinson

Toll free: 1800 447 9407

Fax: 302 288 6884



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