GAMP 5 & Computer Systems Validation (CSV) Basic

Computer Systems Validation (CSV) Basic - Using GAMP 5

This course will provide you with a broad overview of the methods and tools you need to ensure compliance for your computerized systems. You will learn hands-on how to plan, specify, and test your computerized system implementation to secure high data integrity – and ultimately patient safety and production quality. 

You'll be introduced to the background, purpose, and scope of Computer System Validation (CSV) in the life sciences. This includes an overview of the Good Automated Manufacturing Practice (GAMP) life cycle phases and a deep dive into the V-model.

Instructors Stine Kristensen and Dorte Juul will lead you through interactive discussions and activities to ensure you understand and can utilize course concepts in your daily work life. They will leverage their decades of industry experience to weave practical examples and anecdotes throughout the course that bring course concepts to life.

Plus, you'll even take home CSV Templates you can use as a framework for your validation processes.

About Instructors

Dorte Juul holds more than 15 years’ experience within the IT compliance area, working in both the pharmaceutical industry and food ingredients sector, and is highly specialized in GxP. She has performed in leading roles, such as Validation Track Lead on projects, as well Service and Release Manager on production systems. Dorte holds a master’s degree in International Business. She has SAFe Agilist, SAFe Scrum Master and CISA certifications as well as an ITIL Foundation Certification and certifications as Computer Validation Manager and Lead Auditor. 

Stine Kristensen has more than 15 years of pharma industry experience working with IT Compliance, IT Implementation Projects, and System Administration. She has worked both as an external consultant and as internal staff for biotech, pharmaceutical and pharma-related device companies. Stine has worked as IT QA in operation and project phases for computerized systems and Validation Track Lead, as well as in GxP system/infrastructure operation and maintenance. She holds a CISA certification, a SAFe Scrum Master certification, and is trained as Lead auditor for internal and external audits. 

Pia Nøhr Ellegaard has more than 15 years of pharma industry experience working with IT Compliance, IT implementation projects in CSV and SaMD area. She has worked both as external and internal consultant within pharma related IT. She has worked with Requirement management, Test and Validation management as trac k lead as well as a trainer for Test Management systems and CSV. She holds certifications such as DEVops foundation, ECA certified computer validation manger, and ISEB Certified Tester. 

Christian Faxhøj Lisbjerg holds more than 7 years of experience in the Life Science industry working with Compliance, Engineering, Implementations and GxP. He has worked both as an external consultant in the pharmaceutical industry but also as an internal employee as Validation Lead, Project Manager and Compliance Specialist. Christian holds a M.Sc. in Health Informatics and has SAFe Scrum Master, PRINCE2 and Change Manager certifications. 

Who should participate? Any current or future life sciences professional, looking to build a strong CSV foundation. No prior knowledge is required.

Logistics: The course is held in person and the duration is two days, from 9 AM to 4 PM. The course will be held in person at Pharma IT's office in Copenhagen (Skelbækgade 2, 1717 København).

Your purchase includes:

• Meeting materials
• Breakfast, lunch & afternoon snack
• Certificate of course completion
• Pharma IT CSV Templates
• 1-year free membership to the Pharma IT Network