QP Module: Biotechnology Issues
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The course was well organized and the staff was extremely reliable and competent. I’m totally satisfied with the course and I’m looking forward for next one! I strongly recommend it to anyone who wants to have a deeper understanding of the subject.
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Training
In Reading
Description
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Type
Training
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Level
Advanced
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Location
Reading
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Duration
1 Day
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Start date
Different dates available
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.
Facilities
Location
Start date
Start date
Reviews
-
The course was well organized and the staff was extremely reliable and competent. I’m totally satisfied with the course and I’m looking forward for next one! I strongly recommend it to anyone who wants to have a deeper understanding of the subject.
← | →
Course rating
Recommended
Centre rating
Former Student
Subjects
- Biotechnology
- Biopharmaceuticals
- Biopharmaceutical Process and Development
- Contamination risks
- Quality Systems
- Testing
- Problem Solving
- Regulatory Compliance
- Qualified Person (QP)
- Biotechnology Issues
Teachers and trainers (2)
Matt Scotney
Tutor
Paul Lovegrove-Saville
Consultant
Course programme
Course Overview
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.
Suitability
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
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 sentencing process, the types of problems encountered during manufacture and testing, and how they can be resolved
- Understand the future of biopharmaceuticals
Additional information
QP Module: Biotechnology Issues