Course overview
Ensure your computerised systems are fully compliant, reliable, and designed for long-term success. Mastering Computer System Validation provides a deep dive into the critical discipline that underpins trust in digital pharmaceutical operations. This course moves beyond simple testing to show how a well-structured validation lifecycle proves that your systems perform as intended, every time. You will learn how to establish and maintain systems that generate accurate data, maintain robust audit trails, and secure electronic records for the lifetime of your products.
Regulatory expectations have evolved, and so must your approach. In an era of increasing scrutiny, inadequate validation can lead not only to data integrity breaches but also to costly compliance failures and regulatory findings. Through this course, you will understand how to interpret and apply the principles of EU Annex 11, FDA 21 CFR Part 11, and GAMP®5 with confidence and clarity.
This training transforms CSV from a checkbox exercise into a strategic enabler. You’ll explore how validation supports operational excellence, business continuity, and digital transformation initiatives from traditional on-premise systems to modern AI driven and cloud-based platforms. Real world case studies and interactive exercises ensure the lessons translate directly to your workplace.
By the end of the course, you will have mastered a practical, risk-based framework for computerised system validation that aligns with both regulatory requirements and business objectives. Most importantly, you’ll gain the assurance and authority to lead validation activities that withstand inspection, safeguard data integrity, and inspire confidence across your organisation.
CPD Hours: 12
Speakers
Paul Palmer
Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
