QP Module: Biotechnology Issues

5.0
1 review
  • 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.
    |

Training

In Reading

£ 695 + VAT

Description

  • Type

    Training

  • Level

    Advanced

  • Location

    Reading

  • Duration

    1 Day

  • 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

Reading (Berkshire)
See map
Earley Gate, Whiteknights Road, RG6 6BU

Start date

Different dates availableEnrolment now open

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Reviews

5.0
  • 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.
    |
100%
4.8
excellent

Course rating

Recommended

Centre rating

Former Student

5.0
16/06/2017
What I would highlight: 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.
What could be improved: Nothing.
Would you recommend this course?: Yes
*All reviews collected by Emagister & iAgora have been verified

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

Matt Scotney

Tutor

Paul Lovegrove-Saville

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

https://www.rssl.com/pharmaceutical-training/pharmaceutical-training-courses/biotechnology-issues-qualified-person-qp-training

QP Module: Biotechnology Issues

£ 695 + VAT