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Computer Systems 2020 - Computer System Validation Boot Camp 3 Days Virtual Seminar

Date2020-10-07

Deadline2020-10-09

VenueOnline, Online Online

Keywords

Websitehttps://worldcomplianceseminars.com/p/co...-boot-camp

Topics/Call fo Papers

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterwards about it. Thank you WCS for bringing on board such wonderful experts.
We have used our real-world experience to design a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation, but also prepares you to implement these practices in your company. The standard operating procedures and validation templates used in class have already been proven at other companies.
Module 1: Regulation for CSV
FDA Regulations and Guidance
Other Regulations and Guidance (EMA, ICH, EU, MHRA, PIC/S)
Exercise: Exploring the Regulations using the fda.gov website
Speaker:
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe,

Last modified: 2020-10-05 18:00:45