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Event Details


CSV 2018 Workshop


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Who should attend?

Novices Advanced users Senior management Who use computer systems for laboratories, clinical trials, manufacturing, quality, validation IT system vendors


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 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 including DATA INTEGRITY, which are the current, focus regulatory audits worldwide

Some training highlights...

ï‚· International developments in pharmaceutical manufacturing and their likely impact on GCC ï‚· The increased role of and techniques used by management to ensure compliance ï‚· What are the elements of a PQSE with examples of each (ICH Q10) ï‚· What is CAPA and what are compliance requirements for CAPA ï‚· What are the attributes of quality SOPs ï‚· Structure and example of a Validation plan ï‚· Data Integrity, CFR 21 Part 11 and Annex 11 and their differences ï‚· Validation considerations for Commercial off the shelf (COTS) software from software vendors ï‚· How to write good requirements documents and why are they always audited ï‚· Mock internal audit for PQSE, CSV and CAPA performed by trainees DOWNLOAD BROCHURE


45,000/- Per Person. Discount offer of 3+1.


Lisa Brown

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