Process Validation for Biotechnological Products In-House Training

This In-house training provides deeper understanding on how process validation for biotechnological processes.

This In-house training provides deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production.

Key learnings

Perform Clearance

Learn how to Perform Clearance of Impurities, Worst-Case Studies and Excursion Studies.

Set-Up Control Strategy

Understand how to Set-up a Control Strategy.

Learn Qualification

Learn on the Qualification of Cell Banks.

Provide Guidance

Provide Guidance on the Performance of Stability Studies Related to Process Performance Qualification.

Understand to Determine

Understand how to Determine the Number of Process Performance Qualification (PPQ) Runs.

Purpose and Design

Provide Guidance on the Purpose and Design of Continued Process Verification.

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MasterClass Overview Img

Overview

The training aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production.

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Trainer

Hervé Broly

Starting with an engineering degree in agriculture, followed by a PhD in plant physiology, I joined the Blood Transfusion Center (Lille, France) in 1982 where I implemented a unit for the development and manufacture of monoclonal antibodies against blood groups, blood proteins and viral antigens.

Myléne Talabardon

With over 20 years of experience in the pharmaceutical industry, Mylène has a strong experience in process development, technology transfer and process validation. She obtained her PhD in biotechnology from The Ohio State University and her environmental engineering degree from the Swiss Federal Institute of Technology (EPFL).

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Who should attend img RECOMMENDATION

Who should attend?

• Operational managers of pharmaceutical companies

• Packaging designers

• Typesetting & Graphic designers

• IT

• Artwork operators

• Engineering staff

• Suppliers of packaging and authentication technology and pharmaceutical packaging companies are also welcome

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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