Trainings By Informa Markets

GxP, CSV/CSA and Data Integrity for Life Science Environments

04 Dec - 06 Dec 2023

Workshop Overview

Emerging markets in Asia are increasingly seeking contract pharmaceutical manufacturing opportunities in Europe and the US. Consequently, regulatory agencies from these countries such as the USFDA, MHRA, EU, and Anvisa are implementing frequent and stringent audits of these contract manufacturing companies. A review of recent warning letters indicates that 1/3rd of them have been cited for improper validation and lack of data integrity practices and procedures. By attending this 3-day training on Computerized Systems Validation (CSV) and Data Integrity (DI), equip yourself to successfully defend your company during regulatory audits. Hear directly from a US-based expert who pioneered the implementation of CFR 21 Part 11 and has successfully implemented and defended the largest computerized manufacturing system in the world. His extensive implementation experience enables him to make his workshop very interactive where attendees discuss implementation challenges, they face at their workplace.

This workshop is designed for Life Science industry personnel with 2 to 20 years plus. Topics include validation’s predicate rules, System and Validation Lifecycle, writing good requirements documents with examples, ideal content of a CSV and CSA SOP, CSV and DI deliverables that auditors expect, new validation guidance known as CSA, Validation and DI Maturity Model, Data governance and Data management, Data integrity’s 5P model etc.

The trainer will interactively address your specific questions so as to empower you to develop and execute a validation approach for a successful defence during regulatory agency audits.

Program Focus

  • The objective of this training workshop is to ensure that computerized systems in the Life Sciences industry are validated to meet evolving regulatory requirements of Computerized Systems Validation (CSV) and Computer Software Assurance (CSA),
  • Maintenance of CSV and CSA to always meet the regulatory requirements of data integrity.
  • Enhance Data Management and Data Governance skills.
  • Equip delegates with the latest knowledge on Validation Models for Data.

Benefits of Attending

  • Obtain a comprehensive understanding of the principles of computerized system validation and data integrity
  • Learn about the current regulatory requirements for CSV and DI that includes those from USFDA, MHRA, EMA and GCC (Gulf Co-operation Council)
  • Getting hands-on experience with the validation process through participation in mock validation exercises or reviewing validation documentation.
  • Learn from others and share best practices by networking with industry professionals involved in CSV and DI.
  • Stay current on latest trends in CSV and DI by learning new technologies, methodologies, and best practices such as Artificial Intelligence as a tool for CSV, obtaining efficiencies through critical thinking and CSA etc.

Who Should Attend?

  • Pharmaceutical industry / Medical device industry / Healthcare industry personnel
  • Life science industry software developers
  • Validation service providers, IT service providers, system integrators
  • Biologics, OSD, Injectables, Pharmaceutical Manufacturing personnel
  • Regulatory, Quality Assurance and Quality Control laboratory personnel
  • Engineering, Maintenance, Metrology, IT, Data officers and Project managers
  • Clinical trial sponsors and managers, medical device personnel

Similar Workshop

The Basel Landscape - Banking capital and liquidity regulation: from Basel II to Basel III and IV

View Details

ALM & IRRBB - Optimising the Balance Sheet

View Details

Website by: Xpoteck