Designed as a three-day, hands-on learning experience, this course is ideal for manufacturing and quality professionals who want a deeper understanding of this fast-moving area. Through a series of practical workshops, learners will explore real-world challenges and build a well-rounded, 360° view of the industry.
QP professionals require a solid grasp of the quality considerations, formulation needs and processing requirements involved in producing biotechnology and ATMP products. While other modules in the RSSL QP Training Programme touch on these, this course provides the dedicated, in-depth insight needed to truly understand them.
This course is designed for CMC, quality and regulatory professionals involved in the development of biologics and ATMPs across the full product lifecycle, as well as experienced operational quality and CMC specialists working in technical transfer.
It is also suited to quality professionals seeking CPD in these dose formats, manufacturing leads responsible for clinical trial supply and scale-up to commercial production, and process or development engineers managing projects transitioning from R&D into clinical trials or scaling to commercial manufacture.
This course covers the following topics:
CMC fundamentals and quality integration
ICH enhanced process and analytical development concepts
Process engineering foundations
Built-in quality concepts
GMP controls and facility/process qualification
Manufacturing system design
Quality control in action
Regulatory alignment and emerging practice
Harmonising QA and manufacturing strategies
Applied Case Studies (batch failures, personalised therapy manufacturing, digital twins and predictive models in modern QC)
By the end of this course, participants will be equipped to:
Explain the manufacturing principles for biologics and ATMPs, including upstream and downstream processing
Identify and map Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) using a Quality by Design approach
Evaluate facility design decisions and contamination control strategies tailored for complex biologics and ATMPs
Integrate robust quality assurance practices into manufacturing operations, including deviation and CAPA management
Navigate the regulatory framework governing GMP expectations for ATMPs across major regions (EMA, FDA, PMDA)
Collaborate effectively across process engineering and quality control functions to resolve real-world manufacturing challenges
Apply digital tools and innovation to enhance QC reliability and performance
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
Yes, QP Trainee packages are available with RSSL and include a number of exclusive benefits. Contact our QP Training Advisor to learn more on trainingsales@rssl.com or by calling +44 (0)118 918 4000, and join our upcoming webinar, 'To QP or not to QP?', designed for aspiring QPs.
Yes, the QP Biotechnology and ATMP Products 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 QP Biotechnology and ATMP Products course date. When this occurs, we operate a waiting list service.
Yes, we welcome bookings from self-funding 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 QP Investigational Medicinal Products course date that you wish to book your colleagues onto, then:
You will receive an automated email confirming your booking details for the QP Biotechnology and ATMP Products 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.
Yes, this QP Biotechnology and ATMP Products course is available in-person or virtually on the Adobe Connect training platform. If a venue is listed against your preferred course date, then this course is scheduled as an in-person session.
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.
As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to download the app.
Please see our 'minimum requirements' document for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test.
Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees.
All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK.
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.
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.
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
