Equipment/Machine Software Validation According to 21 CFR Part 11 ,EU Annex 11 & GAMP 5 (Embedded and Computerized Software for pharmaceutical Equipment)

Engineering and Validation

Laboratory

Operations

Quality

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Program Description

Topics to be covered with this training includes:

Introduction to Computer System Software Validation
Set the Validation Plan (VP) and make Planning for the CSV for Computerizes/Embedded system
Category of Hardware and Software
Introduction to CSV tests for computerized and embedded system (User authentication, Audit Trail, Backup, Data Recovery, and Disaster Recovery)
Issuing the Validation Protocols/Report
Regulation and Guidelines

Validation and Qualification scientists, Supervisor and Manager
IT Supervisor or Manager
Engineering Department Staff (Maintenance, Project Management, Utilities Engineers)
Professionals from service organizations and vendors who serve pharmaceutical clients
Quality Department (QA, QC, Regulatory Affairs and Compliance)
Regulatory bodies involved in pharmaceutical industries
Internal/External Auditors and consultant

Participants will take Idea the need for Computer Software Validation and especially for the machines used in Pharmaceutical Industries
Participants will take idea of how to incorporate equipment CSV withing Computer System Validation Master Plan
Participants will take an Idea about the categorization for Software and Hardware According to GAMP5.
Participants will take Idea for building the Software Validation Protocols (including Input/Output) for the Computerized (Embedded) Software for Pharmaceutical Equipment
Participants will take Idea about different forms used for Computer Software Validation and how to Follow the Risk-Based Approach
Participants will take Idea about the regulatory guidelines for the sake of successful inspection

Workshop, Sheets and case studies paper will be conducted and implemented during training

Please contact our Business Development team:
[email protected]
00962 798756232