Webinar On Computerized System Validation: Basic Concepts

Compliance Trainings, Online
2015-02-24

Description :

This presentation will diminish the mystery associated with computerized system validation, provide attendees with a clear understanding of the basic concepts of validation, and describe the steps to be taken by a project team leading to a well controlled and successful computerized system validation.

Areas Covered in the Session :

Introduction, Historical Perspective, and Definitions

Computerized System Validation Master Plan

Validation Plan

Developer Assessment

Requirements, Design, and Configuration Specifications

Validation Testing

Procedures/Archival/Traceability

Validation Summary Report

Commissioning Memo

System Decommissioning/Retirement

Questions & Answers

Who Will Benefit:

Recommended webinar for FDA regulated companies, any staff members who may be involved with computerized system validation project planning, validation testing, system use, system support, and regulatory compliance of computerized systems. Professionals who will benefit are:

Project Management

Strategic Management

Quality Assurance staff

IT staff

Operations staff

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 

Email : support@compliancetrainings.com 

Speaker Profile

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley's Business School for Executive Education in Life Sciences and is now on the Stanford Who's Who Registry for her contributions to the Lifesciences industry.

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