FDAnews Extractables and Leachables: Taking a Deeper Dive Webinar December 8, 2021

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FDA interest in extractables and leachables is on the rise, posing complex technical compliance challenges. Here’s what to do ...



Extractables and Leachables:
Taking a Deeper Dive
An FDAnews Webinar
Wednesday, Dec. 8, 2021, 1:30 p.m. – 3:00 p.m. EST

Extractables and leachables regulations have continued to increase. There is a new urgency due to ICH Q3D guideline requirements plus a substantial shift in metal impurity standards. Originally focused on high-risk areas such as inhalation and parenteral drug products, FDA expectations now cover nearly all other dosage forms and dosing devices.

Confusion and misinformation abound. Many sponsors run into trouble understanding and performing appropriate E&L studies, leading to costly delays and raising the risk of regulatory sanctions.    

By attending this Extractables and Leachables webinar on Dec. 8, attendees will learn how to manage extractables and leachables. With expert tips, one will be able to define extractables and leachables and determine which regulatory requirements apply. Discover how to effectively evaluate USP guidelines and industry standards, connecting them to various products along different points in your development cycle. Finally, learn to create a successful extractable and leachable program that will both meet goals and industry best practices.

This webinar will cover:

  • Basic extractable and leachable details

a. The specifics of what constitutes an extractable or reachable
b. Common confusions around these elements

  • Key regulatory requirements

a. Evaluating USP guidelines and industry standards
b. The increasing related regulations around extractables and leachables
c. The differences in applying these standards to various products
d. How regulations apply through the product development cycle

  • Developing extractable and leachable programs

a. How to design an extractable and leachable program that meets = development goals and addresses regulatory requirements
b. Best practices around an extractable and leachable program
c. Recent trends regarding nitrosamines, elemental impurities and identifying unknowns

  • Common challenges

a. Frequent analytical challenges associated with extractables and leachables
b. Handling sensitivity requirements, product interferences and necessary testing

Regulatory requirements around extractables and leachables have been increasing and an effective program to identify these elements and meet these guidelines is essential. Don’t let the changes catch the team off guard.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Extractables and Leachables:
Taking a Deeper Dive
An FDAnews Webinar
Wednesday, Dec. 8, 2021, 1:30 p.m. – 3:00 p.m. EST

$297 per site

Easy Ways to Register:
Online: https://wcg.swoogo.com/extractables-and-leachables
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
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