WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,

Florida,

United States,

ZIP: 33021

Phone:

Overview of the Topic:

Project management principles can be used to ensure that all efforts to develop, configure, implement, test, validate and maintain a computer system is compliant.specific in terms of how this is to be done.

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.specific in terms of how this is to be done. 

Areas Covered

Project planning, execution and management concepts
GxP Predicate Rules
Computer System Validation (CSV)
System Development Life Cycle (SDLC)
Risk-based approach to validation
GAMP V approach to system categorization and validation
Implementation and validation of systems in compliance with FDA
Roles, responsibilities and training
Documentation required for FDA compliance
Maintaining a system in a validated state
Ratio of system cost to compliance with FDA
SOPs required for supporting a validated system
Industry Best Practices
Interactive Q&A

Who will Benefit

Professionals in the following industries may also benefit from the content:
• Pharmaceutical
• Medical Diagnostics
• Biotechnology
• Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
• Animal Health
 

About your Speaker :
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.