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

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.

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

Course Description:

Day 1 – Agenda

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 2 – Agenda

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 4: Quality Assurance for CSV

• How to audit CSV projects

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

About Speaker:

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.

DATE, VENUE & PRICE:

Location: Mumbai| June 5th and 6th 2014| 9 AM to 6 PM

Venue: The LaLiT Mumbai

Venue Address:  Sahar Airport Road, Andheri East, Mumbai - 400059

Price: 

In Rupees:INR 18,000

In Dollars: $ 300

Discount:

Register now and save 2000 (Early Bird)
Until May 15, Early Bird Price: INR 18,000

From May16 to June 03, Regular Price: INR 20,000

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