Implementing Elemental Impurities Testing
ICH Q3D, USP <232> and <233> Requirements

Thursday, Aug. 31, 2017 · 1:30 p.m. - 3:00 p.m. EDT

A little more than a year ago, a paradigm shift occurred in testing for elemental impurities. The then-new ICH Q3D guideline established tough new expectations for new drugs.

Now this guideline is being broadened to affect all approved Rx’s, branded and generic alike. Phase II implementation of ICH Q3D, USP <232> and <233> is about to take place. You have until Jan. 1, 2018, to get ready.

FDAnews is stepping into the breach with a timely Webinar featuring a recognized expert, Dr. Wayland Rushing of EAG Labs. 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.

Starting with a recap of the history of elemental-impurity testing, you’ll move on to examine:

  • Comparison of ICH Q3D vs. USP <232> and <233>

  • Risk assessment and gathering information from suppliers

  • Analytical strategies and techniques

  • Challenges associated with testing

  • Case studies of testing implementation

  • And much more!

Drug and biologics makers, API suppliers and excipient manufacturers all will benefit from this presentation. Make haste though — Jan. 1, and full compliance, will be here before you know it. Sign up now.

Webinar plus Audio CD/Transcript
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$487

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Webinar only
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$287

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24/7 Encore plus Audio CD/Transcript
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$487

add to cart

24/7 Encore Presentation
Learn more

$287

add to cart

Audio CD/Transcript
Learn more

$287

add to cart

 

Who Will Benefit

  • Manufacturing Directors
  • Materials Sourcing Professionals
  • Supplier Management Professionals
  • Testing and In-bound Materials Professionals
  • Quality Assurance/Quality Control
  • Regulatory Affairs

 

Meet Your Presenter

Dr. Wayland Rushing

Director of Scientific Affairs
EAG Labs

For 15+ years he has led CMC development programs for a wide array of biopharmaceutical clients including parenterals, inhalation drugs and other pharmaceuticals with complex delivery systems. He boasts expertise in chemistry, manufacturing and controls program design, analytical development and regulatory submissions.

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.

Phone (703) 538-7600 | Fax (703) 538-7676 | Toll free (888) 838-5578 | Email customerservice@fdanews.com

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