GAMP 5 Second Edition Workshop
GAMP, developed by the International Society for Pharmaceutical Engineering (ISPE), provides guidelines for regulated industries to help ensure the proper use of automation and computerised systems. GAMP 5 is the latest version of these guidelines covering a wide range of systems, including manufacturing equipment, control systems, laboratory instruments and software applications. This practical based workshop explores the development of Computer System Validation (CSV) methodologies and practices aligned with the update of the ISPE GAMP®5 Guide.
While a risk-based approach to CSV is not new, GAMP®5 Second Edition introduces different ways of thinking and challenges the broadly linear approach used previously, providing a framework for a more iterative and incremental model. New appendices cover supplier involvement as well as modern technologies such as cloud computing, software testing tools, artificial intelligence, machine learning and block chain reflecting advancements since the issue of the first GAMP®5 guide in 2008.
As software and computerised systems become more complex, regulators expect robust Quality Risk Management processes. 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 delegates to develop methods, tools and an action plan for implementation at their workplaces.
Interested in GAMP training for your team? Contact us today.
This workshop is aimed at SMEs, managers and leaders working in validation, Quality, IT, OTI, software and system development, engineering and controls supporting the pharmaceutical and Life Science sectors.
This 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
Validating for specific use – risk-based approach
By the end of this 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 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 and long-term goals) to take back to the workplace and share with their colleagues and teams
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.
| Yes, the GAMP 5 Second Edition Workshop can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details. |
| Places will be available for you to book unless it states ‘Full’ next to your chosen GAMP 5 Second Edition Workshop date. When this occurs, we operate a waiting list service. |
| Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems. |
| You will need to first register yourself on our booking system by selecting the GAMP 5 Second Edition Workshop date that you wish to book your colleagues onto, then: - Add the number of people you wish to book onto the course - Register yourself as the booker and complete the fields accordingly - Add the details of those you wish to book for - Complete your order. |
| You will receive an automated email confirming your booking details for the GAMP 5 Second Edition Workshop. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included. |
| Usually, this 1-day GAMP 5 Second Edition Workshop is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000. |
| Our online GAMP 5 Second Edition Workshop begins at 09:00am, although we request that you login at 08:30am to ensure any technical glitches can be resolved before the start time. Please review your course confirmation email to double check the exact start time of your specific course. For our in-person courses, refreshments are available from 08.30am, for a 09:00am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later. If you need an exact finishing time to allow for travel arrangements, please contact us via trainingsales@rssl.com or +44 (0)118 918 4000. |
| Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system. |
| Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you. |
| Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address. |
| Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email. |
| Our classroom courses are fully catered, and we provide all refreshments. If you have any special dietary requirements, please enter these into the ‘dietary requirements’ field when creating your account. Our virtual tutor-led courses will include a 45-minute lunch break. |
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We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
