FDA 21 CFR Part 11 Compliance - Validation Seminar 2018 (Washington DC, United States, June 28-29, 2018) - ResearchAndMarkets.com

DUBLIN--()--The "FDA 21 CFR Part 11 Compliance - Validation Seminar 2018" training has been added to ResearchAndMarkets.com's offering.

Part 11 / Annex 11 Computer Systems Validation (CSV) is implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets.

Spreadsheets are a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training. However, this results in spreadsheets being among the most under-documented systems used in GxP environments because:

  • Users regard them as part of the desktop
  • The ease with which applications can be built without much training
  • The data processing power that they can have
  • Lack of knowledge that spreadsheets need to be validated
  • Lack of knowledge on how to validate spreadsheets

Consequently, Spreadsheets have become low hanging fruit during FDA or other regulatory inspections and many warning letters have been issued.

Agenda

Day 1 Schedule

  • Lecture 1: Types of Spreadsheets
  • Lecture 2: Excel Validation at a High Level
  • Lecture 3: FDA Use of Excel Spreadsheets
  • Lecture 4: Excel Validation Master Plan (VaMP)

Day 2 Schedule

  • Lecture 5: Excel Risk Assessment & Requirements
  • Lecture 6: Excel Functional & Design Specification
  • Lecture 7: Verification & Testing for Excel CSV
  • Lecture 8: Quality Assurance for Excel CSV

For more information about this training visit https://www.researchandmarkets.com/research/wnfbcg/fda_21_cfr_part?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Pharmaceuticals, Drug Discovery, Pharmaceutical Manufacturing

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Pharmaceuticals, Drug Discovery, Pharmaceutical Manufacturing