Discover Electron Microscopy’s Role in Glass Defect Investigations at the PDA Visual Inspection Forum


Wow, I can’t believe that fall has arrived – but with the changing of the seasons comes the 2013 Parenteral Drug Association (PDA) Visual Inspection Forum.  After perusing the agenda, I can’t wait to attend the session presentations and learn from industry case studies. I expect there will be many regulatory updates as well – and in this industry, since we must ensure that quality assurance programs are compliant, it’s imperative to stay “in the know” regarding regulations.  I’m especially interested in participating in discussions about the shift from visual inspection toward automated inspection for particulate detection.

As for my portion of the forum, I will be presenting during the poster session. My poster focuses on how electron microscopy can support glass defect investigations. As you may know from recent recalls, glass delamination is a large contributor to pharmaceutical product contamination. I plan to share electron microscopy’s role in investigating these concerns, and I hope you’ll join me for my poster presentation. My discussion will help you answer questions such as:

  • What are the important benefits that electron microscopy can provide in a glass delamination or defect investigation?
  • How does electron microscopy fit in with other analytical techniques in these investigations?
  • How does electron microscopy serve as a quality control mechanism to minimize the risk of having defective products enter the market in the first place?
  • How does electron microscopy integrate into a larger preventative quality control program?

Through the lens of a number of real-world case studies, I will answer these questions when I present “The Role of Electron Microscopy in Glass Delamination and Other Glass Defect Investigations” on Monday, October 7, at 10:15 a.m.

I look forward to meeting you in Bethesda on October 7 and 8!


Karen Smith

About Karen Smith

Karen Smith is a senior scientist RJ Lee Group, specializing in the identification and characterization of foreign particulate matter (FPM), as well as root cause failure analysis investigations for the life science industry. This expertise appropriately extends to assisting clients in developing proactive measures to manage their FPM issues. Since joining RJ Lee Group in 2008, she has frequently led training courses and presented at seminars for FPM identification. Ms. Smith works closely with clients on contaminant source analysis by interpreting and reporting data. Karen has a keen eye for detail and precision, making her a multi-faceted scientist in failure analysis and overall process methodology.





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