FREE Pharma QA and Validation Testing Training and Placement
Validation of Computer Systems
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FREE Training and Placement with our Fortune 500 Clients!!
Extensive Mock Interview and Resume preparation sessions !!
Who is this course for?
Anyone interested in Validation, Quality, IT, and Business Analysis field for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries.
This course is specifically designed for personnel seeking to enter into computer Systems validation field for pharmaceutical, biotech and medical device industries.
The course is designed to provide a thorough understanding of computer system validation. In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process.
It will also provide a thorough understanding of Computer System Validation Deliverables.
Computer Validation – General Overview
Quality Assurance/Manual Testing Basics
Computer Validation fundamentals
Who needs to validate?
What is Computer Validation?
Why is validation necessary and what regulations guide validation requirements?
Review of the computer validation references in 21 CFR Part 11 Regulations.
What is a GxP Regulated System?
Standard Operating Procedures(SOP)
Change Control Management – Change Requests
What is Testing
Types of Testing
What is a bug/defect
Computer Validation Process and Deliverables
What is the SDLC (System Development Life Cycle) process?
How does computer validation fit into the SDLC?
How 21 CFR Part 11 applies to computer validation
Validation Plans and Master Validation Plans
User Requirements Specifications
Installation Qualification (IQ)
Operational Qualification (OQ) and Performance Qualification (PQ)
SOPs required for system operation and maintenance
Validation Summary Reports
System Release Memo
What is 21 CFR Part 11?
Background and purpose of Part 11
Overview of Part 11
Review of the Part 11 implications in regulations and guidances:
Discussion of example systems and the evaluation of Part 11 Compliance decisions
Templates and examples will be provided for all Validation Deliverables
**The only company that provides training in the Pharmaceutical Validation and Testing Field. **
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