$1,018.95 – $1,318.95

Computer System Validation and 21 CFR Part 11 Compliance

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Sydney

Sydney, NSW 2000

Australia

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Refunds up to 30 days before event

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Description

Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry[1][2]. 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.

Learning Objectives:

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:

  • What is 21 CFR 11 and Computer Systems Validation
  • The FDA’s perspective (also, other regulatory agencies)
  • How to implement 21 CFR 11 and Computer Systems Validation
  • Special Topics: Excel, Cloud and Business Continuity
  • Project Management for 21 CFR 11
  • Quality Assurance for 21 CFR 11

CSV = Computer Systems Validation. This term will be used to described both Computer Systems Validation and Software Validation

Life Sciences industry includes all areas of Pharma, Biotech, Medical Devices, Food, Cosmetics, Companion Animals, Tobacco, Blood products etc.

Who will Benefit:

Industries:

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

Titles:

  • 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


For Registration - http://www.complianceonline.com/system-validation-and-21-cfr-part-11-compliance-seminar-training-80504SEM-prdsm?channel=eventbrite

Note: Use coupon code REFERRAL10 and get 10% off on registration.

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Date and Time

Location

Sydney

Sydney, NSW 2000

Australia

View Map

Refund Policy

Refunds up to 30 days before event

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