GAMP 5 Second Edition Workshop

1 Day/s

CPD Hours: 7

Classroom, In-house

This is a practical based workshop which explores the development of CSV methodologies and practices aligned with the update of the ISPE GAMP®5 Guide.

A risk-based approach to CSV is not new, but GAMP®5 Second Edition introduces different ways of thinking and challenges the broadly linear approach previously used. It provides a framework for a more iterative and incremental model. A number of new appendices have been added to cover supplier involvement as well as cloud computing, software testing tools, artificial intelligence, machine learning, block chain to address development of new technologies introduced since the issue of the first GAMP®5 Guide in 2008.

As software and computerised systems become more complex, in order to determine where additional rigor may be appropriate, regulators would expect to see a robust Quality Risk Management processes in use. Understanding and adapting testing activities to provide objective evidence and assurance is critical to fulfil regulatory expectations. Focusing the validation effort, and validating systems for their intended use will not only align with GAMP®5 Second Edition and regulatory expectations, but will also reduce the cost and time burden when introducing new systems and maintaining compliance of existing systems.

This workshop will provide a framework to critically assess the new features in GAMP®5 Second Edition and will enable the delegates to develop methods, tools and an action plan for implementation at their workplaces

This workshop is aimed at SMEs, managers and leaders working in Validation, Quality, IT, OTI, Software & System Development, Engineering and Controls supporting pharmaceutical and Life Science sectors.

The course covers the following topics:

  • GAMP background and an overview of the updates included in GAMP®5 Second Edition
  • Review of the specific changes and the potential impact on current working practices and processes
  • Value and benefits of adopting new methodology such as:
    • Critical thinking
    • Supplier involvement though the development and qualification process
    • Validating for specific use – risk-based approach
  • Practical sessions to discuss and agree actions for delegates to take back to their workplace

    By the end of the course you will:

    • Understand what is new in GAMP®5 Second Edition and how it aligns with current regulatory expectations
    • Be able to identify the positive impact and benefits of applying the principles defined in GAMP 5 Second Edition
    • Have a practical understanding of how to apply the principles and new methodologies and adapt to the new technologies defined in the new GAMP 5 guidance
    • Have an action plan (with short, medium, long-term goals) to take back to the workplace and share with their colleagues and teams

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Special offer

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We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

John Spenn

John Spenn is an experienced quality professional with over 25 years in the biopharmaceutical / life sciences industry. John has held senior strategic management and leadership roles and has extensive knowledge and experience in quality management and regulatory processes as well as CQV lifecycle for equipment, facilities, utilities, computer systems, sterilisation and cleaning validation. John is currently a director at Dorset Quality Services offering validation and quality consultancy services to the pharmaceutical and life sciences industry. His previous positions include Associate Director and Head of Validation at Lonza Biologics, Cleaning and Process Validation Manager at Porton Biopharma and Validation Manager at Public Health England.

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