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Comparability for Biologics

PTI
Course summary
2 days
English
Vienna
Professional Training

Course description

Comparability

Comparability for Biologics - 2-day training course by Pharmaceuticals Training International

The quality, safety, efficacy and regulatory approval of your biopharmaceuticals is strongly connected to the process changes during the manufacture of recombinant proteins. This essential two-day course gives you a practical insight into how to manage process change so as to ensure regulatory compliance and product consistency throughout the process.

This course illustrated comparability best practice using more than 20 industry case studies, enabling participants to find the best ways to satisfy the needs of the Regulators. At the end of the two-day course, participants will have a clear understanding of the various process changes which may impact the success of their products.

Suitability - Who should attend?

This training course is aimed at professionals specialising in Biopharmaceuticals.

Training Course Content

This two-day programme for professionals in Biopharmaceuticals will cover:

  • The inter-relationship between process change, quality, safety and efficacy
  • The importance of change control, Good Manufacturing Practice (GMP) and the potential of Process Analytical Technology (PAT)
  • The potential significance of various process changes and how these may impact the quality of your products
  • The physiocochemical and biological tools available to monitor the impact of process change
  • Non-clinical and clinical testing programmes that might be required to support major process change
  • The US and EU regulatory requirements following process change

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:

4/5

85% had applied content during the course to their role

Delivery rating:

4/5

Expenses

The cost of this training course is £1595 + VAT per participant, which covers tuition and course materials.

In-house Training

PTI - Pharmaceutical Training International can also deliver this course as in-house training for your company. You can reduce costs, enhance accessibility to training resources and better address your company’s own business goals with a tailored PTI training package.

About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...


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Contact info

PTI

London

 Show phone number
http://www.pti-global.co.uk


Reviews

Average rating 5

Based on 9 reviews

Senior Consultant, Michor Consulting
(5)
I enjoyed the insight we were given from actual projects and the case-by-case discussions
Head of Operations, Ganymed Pharamceuticals AG
(5)
There was great interaction during the course as there was a small group and the open discussion was invaluable
Senior Regulatory Strategy manager, LFB Biotechnologies
(5)
The course was perfect. There was a good balance between the theory of comparability and materical exercises
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Reviews
Course rating
(5.0)
Based on 9 reviews
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