FDAnews Announces — Implementing Elemental Impurities Testing: ICH Q3D, USP and Requirements Webinar, Aug. 31, 2017

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Branded and generic drug and biologics makers, need to brace themselves: Next Jan. 1, every last one of their approved products will be subject to tough new standards known as ICH Q3D, USP [232] and [233].

FDAnews

FDAnews

Implementing Elemental Impurities Testing:
ICH Q3D, USP [232] and [233] Requirements
**An FDAnews Webinar**
Aug. 31, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/impurities

Branded and generic drug and biologics makers, need to brace themselves: Next Jan. 1, every last one of their approved products will be subject to tough new standards known as ICH Q3D, USP [232] and [233].

ICH Q3D is the elemental impurities guideline that now affects new drugs only. Think of it as the USP standards on steroids. But with less than a half-year to comply, some manufacturers have barely started thinking about how it will affect already approved products.

FDAnews is stepping into the breach, with a must-attend webinar featuring an expert from EAG Labs to show the way. For 15+ years, Dr. Wayland 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, attendees will move on to cover:

  •     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. Dr. Rushing boasts expertise in chemistry, manufacturing and controls program design, analytical development and regulatory submissions.

The FDA will broaden enforcement of ICH Q3D in no time. Now is the time to get ready. Sign up today.

Meet the Presenter:
Dr. Wayland Rushing is 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.

Who Will Benefit:

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

Webinar Details:
Implementing Elemental Impurities Testing:
ICH Q3D, USP [232] and [233] Requirements
**An FDAnews Webinar**
Aug. 31, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/impurities    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/impurities                                                                                        
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
FDANEWS
+1 (703) 538-7665
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