Computer system validation & maintenance based on GAMP 5 2nd

Start by gaining fundamental knowledge about computer system validation and maintenance based on the GAMP 5 second edition. Understand concepts such as system categorization, risk management, validation system cycles, and maintenance life cycles. This foundational understanding is crucial for validating your first simple system.

Scope of the Course:

• Definitions, Regulations, Guidelines

• What's New in GAMP 5 Edition 2

• SLC, V-Model, Validation Plan

• Requirement Specification

• Risk Management and Risk Analysis

• Qualification Phase, Validation Report

• Operation Processes & System Maintenance

Course Objectives:

• Gain knowledge about Computer System Validation

• Develop the ability to create your procedures for validating and maintaining systems

• Become proficient in reviewing validation documentation in a GxP-compliant environment."

GAMP 5, which stands for Good Automated Manufacturing Practice is a set of guidelines and best practices developed by the International Society for Pharmaceutical Engineering (ISPE). It specifically addresses the validation and qualification of automated systems used in the pharmaceutical and biotechnology industries. GAMP 5 provides a structured approach to ensure that these automated systems are designed, installed, and operated in a manner that meets regulatory requirements and ensures product quality and patient safety.

In summary, the GAMP 5 2nd edition is a vital resource for pharmaceutical and biotechnology companies seeking to maintain the quality and integrity of their automated systems. By following its principles and guidelines, organizations can enhance the reliability and safety of their manufacturing processes and products while staying in compliance with industry regulations.