Quality Risk Management - How to Apply ICH Q9 In Practice
Quality Risk Management (QRM) is a requirement of the pharmaceutical industry and concerns the process of identifying, evaluating and mitigating risks connected with development and manufacture of medicines and other related products. An effective and robust QRM programme reduces risk to a manageable level and helps to ensure the delivery of quality products to patients.
This highly interactive, one-day training course provides you with a thorough understanding of quality risk management, covering the latest ICH Q9R1 update (18 Jan 2023) and the implications arising from it.
This training is aligned to the latest science and risk-based principles, taking into account regulatory guidances in both the EU and US). It covers the use of QRM in development, manufacturing, engineering, validation and other functions. This training includes reference to ICH Q8 (Pharmaceutical Development), Q10 (Quality Systems) Q11 (Drug Substance Development), and ICH Q12 (Lifecycle).
Interested in quality risk management training for your team? Contact us today.
This course is suitable for those involved in development, manufacturing, engineering or validation who may have no, or limited QRM experience, or wish to update their knowledge regarding the latest developments.
This course will cover the following and include presentations and exercises around:
The regulatory background – EU, US, ICH and elsewhere
ICH Q9R1 – the latest amendments and their significance, plus principles and risk tools
ICH Q8/11 – product and process understanding
Setting up and running an FMEA
Creating your action plan (learning exercise)
By the end of the course you will be able to:
Appreciate the regulatory drivers for QRM, with particular emphasis on European and US requirements
Understand the latest changes and implications of ICH Q9R1 update
Understand how ICH Q9R1 underpins ICH Q8, Q10 and Q11 for activities in development, manufacturing, engineering and process validation
Appreciate the principles of QRM, the ICH Q9R1 framework and the importance of common language and approaches, including the differences between risk management and risk analysis
Recognise the importance of product critical quality attributes, critical process parameters and control strategy in regard to science and risk-based principles
Understand how to set up and run a risk management exercise, including initiation, risk assessment, analysis, control, review and communication
Appreciate how to use various risk methodologies, including FMEA, risk ranking, cause effect matrix and other related techniques, such as process flow diagrams, ‘fishbone’, ‘brainstorming’ etc.
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 Quality Risk Management 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 Quality Risk Management 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 Quality Risk Management course date that you wish to book your colleagues onto, then:
You will receive an automated email confirming your booking details for the Quality Risk Management 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 Quality Risk Management course is conducted in-person 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 visit the download webpage.
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.
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.
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
