Pharmaceutical Product Development, GMP Requirements
The development of pharmaceutical products is a lengthy and costly process. With increasing pressure to get products to market, it is essential to operate in a well-controlled and compliant to achieve market approval as quickly as possible. This raises an important question: how much Good Manufacturing Practice (GMP) is involved to achieve this goal?
Once the manufacture of Investigational Medicinal Product (IMP) beings, the pathway to market becomes more defined, although there are still some flexibilities depending on the phase of the clinical trials involved. This highlights the need for practical GMP guidance for these important stages of the product lifecycle.
This introductory course provides a comprehensive overview of the GMP principles which should be applied during pharmaceutical product development. It is ideal for professionals in the pharmaceutical industry, NHS and academic institutions who seek to understand the differences and challenges associated with the development process, as well as strategies to ensure ensure compliance with relevant GMPs.
Interested in Pharmaceutical Product Development, GMP requirements training for your team? Contact us today.
The course is suitable for any person working in QA or QC, formulation scientists and regulatory affairs personnel, as well as those looking after premises, utilities and equipment.
Trainee QPs or other professionals, who may be in the earlier stages of their career and keen to learn more about GMP expectations, would also benefit from attending this training.
This course covers the following topics:
Legislation and guidelines
Specific GMP expectations for IMP manufacture
How to handle events arising during manufacture or testing
Management of raw/starting materials and suppliers
Documentation expectations during product development
Data integrity – what is expected?
Overview of analytical method development requirements
Overview of stability study requirements
Role of the QP in development and for IMP manufacture
Management of outsourced activities
Inter relationship between GMP/GDP and GCP
Packaging and supply of Clinical Trial (CT) materials
By the end of this course, you will:
Have an overall understanding of the development stages for a pharmaceutical product
Be aware of the legislation and guidelines that are relevant for development and IMP manufacturing/supply activities
Understand some of the practical GMP challenges that face those working in this field and how these can be effectively managed
Feel more confident when interacting with colleagues in other disciplines
As trainee QPs, gain an awareness of product development and IMP manufacture
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 Pharmaceutical Product Development 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 Pharmaceutical Product Development 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 Pharmaceutical Product Development course date that you wish to book your colleagues onto, then:
You will receive an automated email confirming your booking details for the Pharmaceutical Product Development 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 Pharmaceutical Product Development 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.
Contact us to register your interest and we will update you when course dates are confirmed.
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
