Deeper Dive Webinar December 8, 2021


Extractable and leachable:

Take a deeper dive

An FDAnews webinar

Wednesday, December 8, 2021, 1:30 p.m. to 3 p.m. EST

Regulations on extractables and leachables continued to increase. There is a new urgency due to the requirements of the ICH Q3D directive and a substantial change in the standards of metallic impurities. Originally focused on high-risk areas such as inhaled and parenteral pharmaceuticals, the FDA’s expectations now cover almost all other dosage forms and dosage devices.

Confusion and misinformation abound. Many sponsors struggle to understand and perform proper E&L studies, resulting in costly delays and increasing the risk of regulatory penalties.

By attending this extractables and leachables webinar on December 8, attendees will learn how to manage extractables and leachables. With expert advice, one will be able to define extractables and leachables and determine which regulatory requirements apply. Find out how to effectively assess USP guidelines and industry standards, connecting them to various products at different stages of your development cycle. Finally, learn how to create a successful extractable and leachable program that will meet both goals and industry best practices.

This webinar will cover:

  • Extractable and leachable basic details

a. The specifics of what constitutes an extractable or reachable

b. Common confusion around these elements

  • Main regulatory requirements

a. Assessment of USP guidelines and industry standards

b. Growing related regulations on extractables and leachables

vs. Differences in the application of these standards to various products

D. How regulations apply throughout the product development cycle

  • Develop extractable and leachable programs

a. How to design an extractable and leachable program that meets = development objectives and meets regulatory requirements

b. Good practices around an extractable and leachable program

vs. Recent trends in nitrosamines, elemental impurities and the identification of unknowns

a. Common analytical challenges associated with extractables and leachables

b. Manage sensitivity requirements, product interference and necessary tests

Regulatory requirements for extractables and leachables have increased 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 US or +1 (703) 538-7600 worldwide

to find out more about our special multisite discount.

Webinar Details:

Extractable and leachable:

Take a deeper dive

An FDAnews webinar

Wednesday, December 8, 2021, 1:30 p.m. to 3 p.m. EST

Tuition fees:

$ 297 per site

Easy ways to register:

In line:

By phone: 888.838.5578 or 703.538.7600

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