澳门六合彩开奖记录

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Extractables and Leachables in Pharmaceutical Manufacturing Masterclass

5 May 2022 09:00 - 6 May 2022 16:00


Introduction
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: 鈥淲hen is an extractable/ leachable study necessary?鈥, 鈥淗ow do I choose appropriate extraction conditions?鈥 and 鈥淗ow low do I need to go in terms of concentration/amount?鈥.

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.

An exclusive discount of 20% is available for 澳门六合彩开奖记录 members valid until 25/02/2022
Speakers
Venue
Online: live, instructor-led virtual classroom training

Online: live, instructor-led virtual classroom training,

Organised by

Contact information
Sam Jones
Keynotive
+44 204 511 6926
Contact us by email

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