Manufacturing Sterile Products
With the final clause of the EU GMP Annex 1 update on sterile products implemented on 25th August 2024, companies are now expected to now be fully compliant with the new requirements. This two-day course has been aligned with the updated Annex 1 and takes you through a sterile product lifecycle considering the aspects of formulation, manufacturing, and control of sterile products. Within this the areas of cleanroom design and operation are reviewed as are the controls around entry of materials, equipment and most importantly people.
This course will provide valuable underpinning knowledge to all personnel working for companies responsible for the manufacture of sterile products including sterile Active Pharmaceutical Ingredients (APIs) and other sterile materials. It will be of benefit to those working in sterile products manufacturing, quality assurance and quality control as well as support areas such as engineering and training. You might be new to your team or experienced (looking for an update to your knowledge). Either way this course would be ideal for you.
This course includes the following topics:
Introduction to sterile products and why they are important
Regulatory requirements and guidelines for manufacturing sterile products
Formulation and primary packaging considerations
An introduction to microorganisms
Contamination control and clean room design
Controls around people, materials and equipment
Control of critical utilities including water
Steam sterilisation processes and concepts of D and Z values
Process lethality and the F0 concept
Sterilisation by dry heat, irradiation, gassing and filtration
Disinfection and microbiological environmental monitoring
Aseptic process simulations
Testing of sterile products
At the end of the course you will:
Understand the risks associated with sterile products
Appreciate the requirements for contamination control and how this links to clean room design
Understand the controls needed for materials, equipment and utilities
Understand the methods for terminal sterilisation and processes involved in aseptic product manufacture
Understand the different types of sterilisation and how they can be applied
Appreciate the importance of people and the need for trained personnel
Appreciate the role of product testing
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 Manufacturing Sterile 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 Manufacturing Sterile Products 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 Manufacturing Sterile Products course 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 Manufacturing Sterile 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. |
| Usually, this 2-day Manufacturing Sterile Products 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. |
| 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. |
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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
