SCDM: Risk-based Computer System Validation; Reduce Costs and Avoid 483

Datum: 10 July 2020

Tijd: 11.00 AM EST

Locatie: Webinar

This training session describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.

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SCDM India: Welcome to The World of Virtual Clinical Trials- Entering a New Era of Design, Conduct, Monitoring and Analysis

Datum: 27 June 2020

Tijd: 8.00 AM IST

Locatie: Online

The impact of the pandemic may result in a change in the way we live in future; so understanding the capabilities, technology and opportunities on virtual possibilities of conducting clinical trials by ensuring the Design, Conduct, Monitoring and Analysis enables adapting to this paradigm. It thus is a great opportunity for all to be part of this SDE to add to our knowledge as clinical research professionals.

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