QP Pharmaceutical Formulation and Processing - Part 2
The Qualified Person should have a thorough knowledge of formulation and processing of the medicinal products they are asked to certify. The comprehensive six-day course is split into two parts, each three days in duration.
This course provides basic formulation principles, including preformulation studies, bioavailability considerations and the effect of excipients on physical and chemical stability. Each major product category is considered separately with respect to common formulations and processing techniques.
The course also includes practical exercises on typical situations, allowing trainee QPs to enhance their decision-making skills using real life scenarios. Sessions will also focus on key areas that a QP must understand, including process validation and scale-up, facility design, utilities and sterilisation processes.
This is a crucial module for QPs who are, or who will be, involved in certifying commercial or investigational batches of medicinal products. The course is most suitable for delegates with little or no prior knowledge of the subject, although it also offers valuable insights for more experienced professionals.
The course includes the following topics and group exercises:
Preformulation
Water systems
Solution formulation and liquids processing
Syrup formulation and processing
Suspension formulation
Topicals and semi-solids
Inhalation products and complaints
Process validation
Utilities
Formulation of sterile products – standard aqueous products and packaging and non-aqueous, lyophilised and biologics products
Processing sterile products – Annex 1
Steam sterilisation and other methods
Autoclaving considerations
Formulation and manufacturing sterile products
Advances Therapies Manufacturing Products (ATMPs)
By the end of this course, delegates will:
Understand the key pre-formulation data that should be available and the impact of drug properties on product development
Be able to demonstrate familiarity with commonly used excipients and understand the importance of sources and quality on product performance and safety
Have familiarity with formulation and manufacture of the major categories of pharmaceutical products
Understand the factors that can affect content uniformity, stability (physical, chemical and microbiological) and bioavailability
Understand the critical processing techniques, their limitations and critical control parameters
Understand principles of process validation, scale-up and technology transfer
Know how to recognise the potential sources of cross contamination and mix-ups during manufacture of pharmaceutical products
Appreciate issues with storage and transportation of finished products
Be familiar with key annexes in the Orange Guide relating to processing and validating of product
| 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 Pharmaceutical Formulation and Processing 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 Pharmaceutical Formulation and Processing 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 Pharmaceutical Formulation and Processing 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 QP Pharmaceutical Formulation and Processing 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 3-day QP Pharmaceutical Formulation and Processing 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. |
| Our online QP Pharmaceutical Formulation and Processing course 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. |
| 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. |
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