Extractables & Leachables Analysis

covering a range of drug product types (e.g. Inhalation, Biologics, ADCs, Cell & Gene Therapies)

Days
Hours
Minutes
Seconds
online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

Since its inception the topic of extractables and leachables has grown continuously. It has expanded into different dose forms and heighted regulatory expectations. Analytical requirements still remain a challenge to effectively detect, identify and quantify, and this area if not addressed correctly can add costly delays to the development of new and existing medicines.

The key to successfully negotiating its potential pitfalls is an understanding of its core concepts and requirements. This course sets out to provides that detail.

meet the training leader
Jason Creasey
Managing Director, Principal Consultant
Maven E&L, UK
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Extractables & Leachables Analysis online training organized by Fleming_Agenda Cover
Extractables & Leachables Analysis online training organized by Fleming_Agenda Cover
Extractables & Leachables Analysis online training organized by Fleming_Agenda Cover
key training

Topics

An introduction to a multifaceted area of E&L

Core concepts and requirements

Case study examples

Guides to extractable and leachable study

Risk management of leachables

Toxicological assessment of leachables

Regulatory guidance and standards

Benefits of attending

In association with

phetairos_logo

Phetairos is an associate community of world-class biopharmaceutical consultants and subject matter experts. We help our clients by using our combined experience and industry best practice to design and deliver innovative solutions across the entire biopharmaceutical value chain. Our independent “hands-on” approach helps our clients to release the full potential of their products, organisations & people. We are dedicated to consistent delivery of successful client outcomes through collaboration, quality assurance, flexibility, cultural alignment, transparency and knowledge sharing.

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