Join us for a TIPA seminar on the practical implementation of computerized system validation (CSV) on 19 – 20 March 2024. This seminar will equip participants with essential knowledge and skills for navigating the complexities of system validation in accordance with regulatory requirements.
Highlighted topics include:
- Regulatory requirements: Delve into the specifics of regulatory standards such as 21 CFR Part 11 and Annex 11, gaining a thorough understanding of their implications for computerized system validation.
- Generic compliance and computer process design: Explore strategies for ensuring generic compliance and optimizing computer process design to meet validation criteria effectively.
- Validation approach for each GAMP category: Learn about validation approaches tailored to different GAMP (Good Automated Manufacturing Practice) categories, allowing for a systematic and efficient validation process.
- Excel spreadsheet validation: Gain insights into the unique challenges of validating Excel spreadsheets, and discover best practices for ensuring their compliance and reliability.
- Risk-Based approach for validation activities and routine operation steps for implementation the CSV: Understand the importance of a risk-based approach in validation activities, and discover how to implement this approach effectively to prioritize validation efforts.
This seminar offers a unique opportunity to gain practical insights and actionable strategies from industry experts, empowering participants to navigate the complexities of computerized system validation with confidence.
Also, don’t miss the opportunity to visit the Factorytalk stand at the event. Meet us to explore innovative solutions and services designed specifically for the CSV and pharmaceutical industries. From cutting-edge technology to industry-leading expertise, FactoryTalk has you covered.
Date: 19th – 20th March 2024
Location: Ambassador hotel, Sukhumvit 11
Time: 9 am – 5 pm
To secure your spot before 11 March 2024!
