YourGateway August 2011 Issue

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Gateway Analytical Registers with U.S. Food and Drug Administration

In June, Gateway Analytical registered with the U.S. Food and Drug Administration, taking a necessary step in the certification of its quality system for pharmaceutical analysis.

“This registration with the FDA demonstrates our commitment to our quality system which is the basis of all of our analytical testing services,” said David Exline, Senior Vice President of Gateway Analytical. “Our goal is to take the same approach with regulatory entities in other industries that we serve.”

Gateway Analytical complies with current good manufacturing (cGMP) standards and is currently implementing procedures conforming to guidelines compliant with 21 CFR Parts 210 & 211, ISO/IEC 17025:2005, ISO 9001:2008 and ASCLD/LAB-2006 Supplemental Requirements.

For more information, contact Tricia Wood, Quality Assurance Manager, at

Trace Evidence Symposium 2011 Recap

Themed Science, Significance and Impact, the 2011 Trace Evidence Symposium, an annual conference co-sponsored by the Office of Justice Programs’ National Institute of Justice (NIJ) and the Federal Bureau of Investigation (FBI) Laboratory Division, brings together trace evidence, law enforcement and legal practitioners and researchers to enhance information-sharing and promote collaboration. This year’s meeting in Kansas City, Mo. was brimming with compelling workshops and research findings, as well as emerging analytical techniques.  In case you missed it, here are some highlights of our activities there.

Debating the Merits of Trace Evidence Analysis and Interpretation
Panelists: David Exline, Senior Vice President, Gateway Analytical; Rock Harmon, Consultant; Maureen Bottrell, Federal Bureau of Investigation; and Michael Risinger
An opening panel, this session examined current challenges, concerns and successes in trace evidence practice.

David Exline, Senior Vice President at Gateway Analytical, discusses his research on using a combined Raman/LIBS system for forensic analysis

Poster Presentation: Hyperspectral Imaging as a Method of Detecting and Visualizing Ignitable Liquid Residues
Presented by:
Cara Plese, Forensic Scientist
This preliminary research investigated fluorescence hyperspectral imaging (HSI) as a means to detect and visualize Ignitable Liquid Residues (ILRs) on both aged and fresh carpeting and clothing samples. HSI detects ILRs by visualizing the fluorescence of the dyes and additives that remain after the hydrocarbon component becomes undetectable by other analytical techniques.

Poster Presentation: Analysis of Trace Evidence Using a Combined Raman/LIBS Microscope System
Presented by: David Exline, Senior Vice President
This presentation addressed the use of a combined Raman/LIBS system for the analysis of single particle and large particle population samples to evaluate the benefits and limitations of such a technique in “real world” forensic applications.



Miss our webinars on pharmaceutical forensics or advancing OINDPs through in vitro testing? Click below to catch their replays.

Advancing Development of Generic OINDPs through In Vitro Testing
This webinar recording demonstrates how novel analytical methods, along with scientific and regulatory expertise, can help cut the time and costs associated with getting generic orally inhaled and nasal drug products (OINDPs) to market. This one-hour webinar addresses:

  • FDA guidance that control various aspects of both chemistry, manufacturing and controls (CMC) and bioactivity/bioequivalence requirements
  • Regulatory pathways for generic OINDP products
  • Current trends in in vitro novel analytical method development
  • FDA Critical Path Initiative for bioequivalence of nasal spray suspensions
  • Nonconformance issues or deviations of drug product during manufacturing via pharmaceutical forensics

Solving Contamination Issues with Pharmaceutical Forensics
This webinar recording examines how a new, advanced problem solving approach called pharmaceutical forensics can help to quickly identify foreign particulate matter and answer questions as to how, where and when it originated. This one-hour webinar addresses:

  • How a forensic approach yields more valuable information
  • Common analytical techniques used
  • Source determination of contaminants
  • Role of a quality system in preventing future contamination issues
  • Cost advantage of outsourcing such investigations


Upcoming Tradeshow Events

From R&D to nonconformance testing, learn how Gateway Analytical can be a key resource for you.  Visit us at these upcoming conferences: