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.
FALLS CHURCH, Va., May 5, 2021 – Extractables and Leachables: 101 An FDAnews Webinar
Wednesday, May 12, 2021, 1:30 p.m. – 3:00 p.m. EDT
https://wcg.swoogo.com/extractables-and-leachables-101
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: 101 webinar on May 12, learn how to manage extractables and leachables. With expert tips, attendees 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 you off guard.
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
This news was shared to Prittle Prattle News via press release.
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