Process Validation and Qualification, Including Validation Methods
This course provides training and practical tools for, facility/equipment qualification, process validation and analytical method validation, including reference to international regulatory guidances from ICH, FDA, EMA and elsewhere. The training will also incorporate facility/equipment qualification, process validation and validation of analytical methods for requirements in Europe, US and elsewhere, including ICH.
Interested in process validation & qualification training for your team? Contact us today.
This course is suitable for those working in most pharmaceutical companies (e.g., those producing novel medicines, generics manufacturers, suppliers/contract manufacturers, etc.) and is applicable to scientists, engineers, process validation/qualification professionals working in development, manufacturing, quality, engineering, validation and other related support functions.
During this two-day course the following topics will be addressed:
Why validate?
International regulatory requirements, e.g. US, EU & elsewhere
Science and risk-based approaches
The three stages of the validation life cycle (Ref FDA & EU)
Understanding product and manufacturing process requirements
Importance of control strategy
Application of Quality Risk Management
Readiness
Process validation
Determining the number of validation batches
Qualification of equipment and utilities
Maintaining control of product over its life cycle, including monitoring
Analytical method validation
By the end of this course, you will:
Understand regulatory requirements in EU, US and internationally for process validation, qualification and analytical methods
Understand the three-stage approach to process validation and its applicability internationally
Be able to apply tools and techniques to help clarify validation deliverables
Appreciate the importance of science and risk-based approaches to validation and alignment to ICH Q8, Q9 and Q10
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 Process Validation and Qualification course 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 Process Validation and Qualification course 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 Process Validation and Qualification course date that you wish to book your colleagues onto, then:
You will receive an automated email confirming your booking details for the Process Validation and Qualification course. 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 2-day Process Validation and Qualification course 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.
When online, this course begins at 08:45am, although we request that you login at 08:30am for registration. For our in-person courses, refreshments are available from 08.30am, for a 08:45am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later.
Please review your course confirmation email to double check the exact start time of your specific course. 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.
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
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
