Count Every Second Until the Event

28
Days
10
Hours
35
Minute
40
Second
2022-05-05 9:00

Course Overview

The regulatory requirements concerning the control of Extractables and Leachables (E&L) have become much more onerous in recent years. This course sets out the regulatory and scientific considerations in a logical, stepwise manner and offers practical advice for compliance. The course answers questions such as: “When is an extractable/ leachable study necessary?”, “How do I choose appropriate extraction conditions?” and “How low do I need to go in terms of concentration/amount?”.

Regulators will expect a risk-based approach to compliance, and the steps involved in an E&L risk assessment are described. To facilitate a risk-based approach, typical extractables from various types of plastics will be described, and risk factors for glass erosion will be discussed. In addition, common errors in the design or application of Extractables and Leachables studies will be explained, together with insights into common analytical techniques and analytical errors.

The course includes workshops and interactive discussions.

Why join the event

Key takeaways of the program

A deeper insight into the science behind E&L evaluation

An overview of regulatory landscape and requirements for E&L studies

An appreciation of the use of E&L databases in mitigating study design and execution risks

An understanding of how to design efficient E&L studies that meet the requirements of regulatory authorities

A high-level view of recent and upcoming changes to US Pharmacopoeia (USP)

Understand how to focus on materials and products that pose the greatest risk

Improve the quality of extractable/leachable data

Answers to your questions on E&L

Who Should Attend

An event precisely for you

Extractables and Leachables/E&L Professionals
Extractables and Leachables/E&L Professionals
QA/QC Professionals
QA/QC Professionals
Formulation Development Scientists
Formulation Development Scientists
Analytical Development Scientists
Analytical Development Scientists
Regulatory Affairs Personnel
Regulatory Affairs Personnel
CMO / CRO Scientists
CMO / CRO Scientists

The speaker

Meet your trainer

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s AnalyticalDivision and led a working group on continuing professional development until July 2016.

He has worked at a senior level in several companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes, including stability evaluation.

In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved managing the analytical and stability aspects of early and late-stage pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, root cause analysis and stability/stress studies.

Dr. Mark Powell

Dr. Mark Powell

Director
Mark Powell Scientific Limited

The Curriculum

What you’ll get from this exclusive event

Fresh Content

Knowledge is only useful when it is relevant. This event is based on the latest research, best practices and industry information. As a result, we close events with a strong knowledge base that helps achieve same-day results.

Networking

Meet and collaborate with like-minded professionals across the globe. Grow your professional network, exchange ideas, and learn more about the industry with your own peers, together.

Experience

Experience comes with practice, and this event will guide you on the right path in becoming a well renowned expert in your field. You will learn through a combination of lecture-based content, real-life case studies, and a more hands-on experience.

Q&A Session

By joining this class, you will be given the opportunity to constantly engage with your peers and raise your concerns, questions, or doubts you may have pertaining to the subject. And, receive well-founded, well-thought-out answers to your every need by leading experts in the industry. 

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