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This course has value for a wide audience, as it provides a good introduction to this exciting sector. It will give a foundation level knowledge that will help potential contract QPs, those moving in to the biotechnology sector and all those who may need an understanding for auditing purposes.
The QP needs to understand the quality issues associated with the manufacture of biopharmaceuticals. Other modules in the RSSL QP Training Programme are based around the Study Guide, and therefore cover biotechnology products alongside other product types.
This workshop has been designed to pull together the information in a way that provides participants with a good overview of the quality and regulatory issues surrounding the development and production of biopharmaceuticals for global use
Learning Outcomes
By the end of the course you will:
Know how biopharmaceuticals are different from other products
Know what the key regulations are and the impact they have
Understand the biopharmaceutical process and the development of products
Understand the facilities, utilities and equipment and how they are qualified
Know what the contamination risks are and the controls to minimise the risks, including viral and TSE control strategies
Understand quality systems for biopharmaceuticals
Have an insight in to the types of testing regimes and their issues, during both development and licensed product manufacture
Understand the batch sequencing process, the types of problems encountered during manufacture and testing, and how they can be resolved
