At 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 sentencing process, the types of problems encountered during manufacture and testing, and how they can be resolved
•Understand the future of biopharmaceuticals
Who should attend:
This 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.
•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 sentencing process, the types of problems encountered during manufacture and testing, and how they can be resolved
•Understand the future of biopharmaceuticals
Who should attend:
This 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.
