FDAnews Announces -- Extractables and Leachables: 101 Webinar, July 10, 2019

FALLS CHURCH, Va., June 26, 2019 /PRNewswire-PRWeb/ -- Extractables and Leachables: 101
**An FDAnews Webinar**
Wednesday, July 10, 2019 ? 1:30 p.m. ? 3:00 p.m. EDT
https://www.fdanews.com/extractablesandleachables101

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 still run into trouble understanding and performing appropriate E&L studies, leading to costly delays and raising the risk of regulatory sanctions.    

FDAnews has called upon one of the savviest experts in this highly technical area, Dr. Wayland Rushing, for plain-English explanation and analysis to aid compliance efforts:

• Extractables and leachables: What they are, special issues they pose
• Regulatory requirements: ICH Q3D guideline requirements and more
• Designing an E&L program: What to consider
• Analytical challenges associated with E&L

Over his career, Dr. Rushing has led CMC development programs for a wide array of biopharmaceutical clients including parenterals, inhalation drugs and other pharmaceuticals with complex delivery systems. He has examined this issue from every angle, making him precisely the right instructor to get attendees on track to full compliance. Why wait?

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: 101
**An FDAnews Webinar**
Wednesday, July 10, 2019 ? 1:30 p.m. ? 3:00 p.m. EDT
https://www.fdanews.com/extractablesandleachables101

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/extractablesandleachables101
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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