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Ref : 26996
Event :Computer Systems Validation

Date :Thursday May 03rd, 2018

Location :Training Doyens 26468 E Walker Dr,Aurora, Colorado
80016-6104 Aurora, United States

Type :Conference & Seminar - International audience

Accreditation :--


Further information




This will cover the history of Computer Systems Validation in the Pharmaceutical and Medical Device industries. This led to the regulation 21 CFR Part 11, which covers the management of both electronic signatures and electronic records.

Compliance to relevant regulations using Standard Operating Procedures and required documentation will be covered. 

The roles of Audits, Quality Assurance, and Risk Management will also be covered.


Changes continue to be implemented in many existing computer systems and in many cases computer systems are being replaced or upgraded using new technologies.  

Many of these changes require Validation and Validation typically involves almost everyone who uses or supports the systems.

Doing Validation is a “Project” that requires participation of many of those involved in the system. Some of this involves strong management commitment to the accuracy and quality of the products of the systems.


  • History of Validation Regulations
  • Some CSV Standards to use
  • Standard Operating Procedures
  • Necessary Documentation


  • Understand Computer Systems Validation
  • Cover The role of Electronic Records
  • Learn the Compliance to 21 CFR Part 11
  • The role of Qualification in Validation
  • Preparation of Standard Operating Procedures
  • The Documentation needed for Validation


  • IT Staff
  • Computer System Users
  • Quality Assurance
  • Regulatory
  • System Vendors


For more detail please click on this below link:



Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882





Map and directions
Conference address :
Training Doyens 26468 E Walker Dr,Aurora, Colorado
80016-6104 Aurora
United States
tel : +1-720-996-1616
Map and directions

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Computer Systems Validation Pharmacy
computer system validation, computer system validation guidelines
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For more information on Computer Systems Validation, plsase contactr Training Doyens

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