Computer System Validation

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About CSV

In the biopharmaceutical space, regulatory compliance is a part of a firm’s business thinking. Regulatory agencies worldwide such as GCC, MHRA, USFDA, EMA, TGA, ANVISA etc. are harmonizing the regulations to assist the industry in complying with them. To keep the industry abreact with the changing regulations, Biotrains has designed this workshop to examine the key local and global regulatory developments affecting GCC regulations, Module 3, and their evolution in 2017 and beyond.

This workshop is for novices, advanced users, senior management and others who use computer systems for laboratories, clinical trials, manufacturing, quality, validation and IT system vendors. It addresses GCC Module 3 topics such as Pharmaceutical Quality Systems Elements (PQSE), Data Integrity elements, Corrective and Preventive Action (CAPA) and Computer Systems Validation (CSV).

The workshop is designed to provide attendees with the knowledge and working skills on complying with the requirements with GCC regulations Module 3 including Data Integrity, which is the current, focus regulatory audits worldwide.

Benefits of Training...

  • Pharmaceutical industry / Medical device industry / Healthcare industry personnel
  • Developers of software for use in Life Sciences industry
  • Validation service providers, IT service providers
  • Manufacturing personnel and Manufacturing Automation system vendors and system integrators
  • Regulatory Affairs group, Quality Unit, Maintenance, Engineering, Manufacturing
  • Clinical trials companies