91AV

Course Scope

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

• Understand the future of biopharmaceuticals