FDAnews Announces Metal Impurities in Finished Drug Products Webinar, Nov. 13

Share Article

The ICH is rewriting the rules on metal impurities in manufacturing — with barely any notice. Drugmakers … worried your company will get caught short?

Metal Impurities in Finished Drug Products
Dealing with a Changing and Uncertain Landscape
**FDAnews Webinar**
Nov. 13, 2013 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/MetalImpurities

Drugmakers received a nasty surprise a few months ago as the ICH proposed new rules regarding metal impurities in finished drug products.

How to prepare for compliance in a changing and uncertain landscape?

Luckily, FDAnews has secured a top expert on metal impurities, Nancy Lewen, to explain the new guidance. In 90 information-packed minutes, she’ll help attendees understand what’s going on and how to prepare for compliance — starting now. Attendees will discover:

  •     Potential impacts of Q3D guidelines on drugmakers’ sourcing, testing and manufacturing processes
  •     How the Q3D guidelines match up against the in-development USP 232/233 standards
  •     Proven ways to make sure suppliers are up to snuff on testing
  •     Risk assessment strategies for controlling elemental impurities
  •     How compliance with USP water quality requirements can lower your level of elemental impurities
  •     The difference between in-house vs. outsourced testing
  •     And much more

The new metal impurity limits are likely to cause upheavals in quality management and in-bound materials testing departments at drugmaking facilities worldwide. Be proactive. Act now to head off regulatory tangles tomorrow. Register now.

WHO WILL BENEFIT
Here’s a suggested list of potential participants:

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

MEET YOUR INSTRUCTOR
Nancy Lewen is a specialist in atomic spectroscopy techniques, with more than 25 years’ experience at Bristol Myers Squibb. She is a member of the USP chemical analysis expert committee, and sits on the USP Elemental Impurities Advisory Panel as well as the USP modernization and waters subcommittee. She is a recipient of the BMS Chemistry Leadership Award, and the Outstanding Women in Science Award from the New Jersey Association of Biomedical Research.

Conference Details
Metal Impurities in Finished Drug Products
Dealing with a Changing and Uncertain Landscape
**FDAnews Webinar**
Nov. 13, 2013 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/MetalImpurities

Tuition
$547 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register
Online:     http://www.fdanews.com/MetalImpurities
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

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
@FDAnewsPharma
since: 07/2009
Follow >
FDAnews
since: 12/2011
Like >
FDAnews

Visit website