Pharmaceutical Product Development, GMP Requirements

GMP in Pharmaceutical Development: Navigating Compliance from IMP Manufacturing to Market Approval

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. 

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Duration
2 days
CPD Hours
14 hrs
Locations
  • Online

Who Should Attend

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. 

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Key Topics

This course covers the following topics:  

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    Legislation and guidelines  

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    Specific GMP expectations for IMP manufacture 

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    How to handle events arising during manufacture or testing 

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    Management of raw/starting materials and suppliers 

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    Documentation expectations during product development 

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    Data integrity – what is expected? 

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    Overview of analytical method development requirements 

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    Overview of stability study requirements 

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    Role of the QP in development and for IMP manufacture 

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    Management of outsourced activities 

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    Inter relationship between GMP/GDP and GCP 

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    Packaging and supply of Clinical Trial (CT) materials 

Learning Outcomes

By the end of this course, you will: 

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    Have an overall understanding of the development stages for a pharmaceutical product  

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    Be aware of the legislation and guidelines that are relevant for development and IMP manufacturing/supply activities 

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    Understand some of the practical GMP challenges that face those working in this field and how these can be effectively managed 

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    Feel more confident when interacting with colleagues in other disciplines 

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    As trainee QPs, gain an awareness of product development and IMP manufacture 

Meet your expert tutors

Learn from the best in the industry.  Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you. 

 

Frequently asked questions

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.

Book Your Place

Pharmaceutical Product Development, GMP Requirements

Contact us to register your interest and we will update you when course dates are confirmed.


£ 1640 excl VAT
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Bespoke Training

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.

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Special Offers

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

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Why choose RSSL?

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.

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    More than 30 years of experience upskilling pharmaceutical professionals

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    Small-group training adjusted to individual learning styles and needs

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    50+ training courses accredited by recognised industry bodies

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    Combination of off-the-shelf and bespoke training packages

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    Courses and consulting led by experts in the entire pharmaceutical life cycle

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    Opportunity to share and learn as part of a diverse community