Entry Level Process Validation for Biotechnological Products MasterClass - EU edition

18-21 November, 2024

QbD concept, process validation, and regulatory requirements!

This course will cover the definition of QbD concept and process validation, describing all key studies and scientific requirements for developing your biotechnological product.

18-21 November, 2024, Virtual

Time Zone: UTC/GMT+1 /CET

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Key learnings

Understand

Understand the purpose of process validation and its 3 stages

Learn

Learn the content of IND and CTD documents

CQAs, CMAs & CPPs

Understand how to assess the criticality of quality attributes (CQAs), material attributes (CMAs) and process parameters (CPPs)

Microbiological Risks

Understand how to assess microbiological risks (including viruses) during manufacturing

Process Performance Qualification

Understand how to determine the number of process performance qualification (PPQ) runs, how to perform PPQ and how to assess PPQ-derived data

Provide

Provide keys to drive a process validation project to success

Trusted by over 17,000 delegates across leading companies

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Overview

This masterclass will introduce participants to QbD concept, process validation and regulatory requirements, and will provide as well keys to successfully drive your product to market authorization.

This course will cover the definition of QbD concept and process validation, describing all key studies and scientific requirements for developing your biotechnological product. It will describe FDA and European guidelines, including the review of the IND and CTD documents, in term of regulatory expectations, to guide you to the market registration of your product.

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Trainer

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). In 2001, she joined BiogenIdec in cell culture process department, focusing on antibody production from lab scale to manufacturing scale. In 2004, she has been appointed head of cell culture department at Merck Serono and started working in validation according to QbD for biotech products. After 2 years as CMC lead for a biosimilar product, she was nominated Process Validation Expert, and in this position, she developed the Global Process Validation strategy for the company according to European and FDA regulations for pharmaceuticals, and supported CMC teams in developing Process Validation plans for new biologics as well as for legacy products.

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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
pass

Team participation?

*minimum of 10 participants

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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 its 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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