Pharmaceutical BA, QA and Validation Training and Placement / Online Event

Online Event

COMPUTER SYSTEMS VALIDATION FOR REGULATED INDUSTRIES

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.

Learning Objectives

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.

Course Description

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

Software Testing (QA)
Concepts of testing and Software Development Life Cycle.
Both Black box testing and White box testing.
In-depth coverage of the testing terminology.
Detailed power point presentations explaining each and every phase of testing.
Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC)
Application testing and product testing.
Web application testing
Complete QA release process

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
Traceability Matrix
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 guidance:
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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***Extensive Mock Interview and Resume preparation sessions !!***

***FREE Placement services with our Fortune 500 Clients!!***

For more info:
Email: Maria@futurethoughtsllc.com

http://futurethoughtsllc.com/CSVTraining.aspx

Attendance: FREE

Event Organizer: Future Thoughts, LLC

Register Online