Process Validation for Biotechnological Products - Australian edition MasterClass

20-23 March, 2023

This MasterClass will provide best understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production.

Process Validation for Biotechnological Products MasterClass 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.

20-23 March, 2023, Virtual

Time Zone: Australian Central Daytime (ACDT)

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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.

Trusted by over 17,000 delegates across leading companies

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Pharma Online Masterclass

Overview

Process Validation for Biotechnological Products online 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, would be appropriately designed and executed to establish scientific evidence that a manufacturing process is capable of consistently delivering quality product.

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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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Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

Gain value and learn from the best instructors

Networking

Build a top-notch community and advance your career

Who should attend img RECOMMENDATION

Who should attend?

• Process development scientists and managers
• CMC development program managers
• Pharmaceutical development scientists and managers
• Manufacturing managers
• QC and stability control managers
• Heads of Quality Assurance
• Drug Regulatory Affairs managers

Ticket options for you

Full event
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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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