KURSUS
Introduction to GAMP5
Strengthen your understanding of Good Automated Manufacturing Practice (GAMP5) and learn how to apply a structured and risk-based approach to computerized systems within the pharmaceutical and life science industries.
Kursusdetaljer
Roskilde
4. november 2026
Varighed: 2 dage
10.000,00 - 10.500,00 kr.
Priser er ekskl. moms
Engelsk
This two-day course provides a solid foundation in GAMP5 principles, enabling you to plan, develop, and maintain compliant automated systems that meet current regulatory expectations for product quality, patient safety, and data integrity.
The course combines theoretical insights with practical exercises based on a realistic project scenario. Through discussions, examples, and group work, participants will translate GAMP5 concepts into hands-on practice.
During the course, you will:
- Gain a clear understanding of the GAMP5 principles and its role in ensuring compliant computerized systems.
- Learn how to define and structure Requirement Specifications (RS) so they are specific, measurable, achievable, and prioritized to minimize errors and misinterpretations.
- Understand software categorization and how to apply scaling principles according to system complexity and risk.
- Learn which documents are required throughout the system lifecycle and how to apply them effectively.
- Acquire practical tools for identifying, assessing, and mitigating high, medium, and low risks.
- Discover how to make the most of documentation in daily operations and ensure it supports both compliance and efficiency.
- Build a shared understanding and terminology across disciplines to improve collaboration and consistency.
- Explore the GAMP system life cycle and how it supports structured project execution.
After the course, you will be able to:
- Navigate current GMP rules and guidelines for development and validation of computerized systems.
- Identify which documents and phases are relevant during system planning, design, testing, and operation.
- Recognize typical challenges at different stages of the system life cycle and across varying levels of system complexity.
- Apply risk management principles to ensure patient safety, product quality, and data integrity.
- Adapt specification and verification activities to match the size and criticality of your system.
- Understand how pharmaceutical companies can implement supplier requirements efficiently to avoid redundant work.
- Know how suppliers can align with the expectations and compliance needs of their pharmaceutical clients.
Target Audience
The course is intended for engineers, technicians, chemists, and other professionals in the pharmaceutical industry who work use computerized systems, including:
- Automation-and IT-engineers
- Project engineers and -leaders
- QA and compliance specialists
- IT-responsibles
- Process technicians and chemists
- Machine builders and robot suppliers
Sharing of Contact Information
Confirm
This course is delivered in collaboration with Confirm. When you register for the course, your name, email address, and phone number will be shared with Confirm. The contact information will be used solely for purposes related to the administration and delivery of the course.
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