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Computer Systems Validation


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

WHY SHOULD YOU ATTEND

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

AREAS COVERED

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

LEARNING OBJECTIVES

Understand Computer Systems Validation
Cover The role of Electronic Records
Learn the Compliance to 21 CFR Part 11
The role of Qualification in Validation

WHO WILL BENEFIT

IT Staff
Computer System Users
Quality Assurance
Regulatory
System Vendors

For more details click on this link:
http://bit.ly/2EFNiQ6

You may also refer to this link:
https://www.trainingdoyens.com/product/50169-oos-oot-investigation
https://www.trainingdoyens.com/product/50175-capa-training-webinar

Ticket Price:

Live Webinar : $199

Recorded Webinar : $219

Training DVD or USB Flash Drive : $399

Super Combo Offer 1 : $329

Super Combo Offer 2 : $499


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