Recently, the American Association of Pharmaceutical Scientists (AAPS) released a post on their blog authored by Binodh DeSilva, Executive Director of Immunochemistry and Biomarker Development and Mark E. Arnold, Ph.D., Executive Director of the Bioanalytical Sciences and Selective Integration Department at Bristol Myer Squibb on the FDA and industry discussing crucial draft bioanalytical method validation guidance. Here is an excerpt from the post:
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In the day and age of emails, texts and social media; communication has become an ever present topic of discussion. After all, why would Led Zepplin take the time to sing about communication (and its breakdown…) if it wasn’t such a large part of our lives? But even with all the new technology we have at our fingertips today, communication has always been something that professionals are expected to master and execute with ease. This is an especially important skill set when considering quality, as communication is imperative to not only the maintenance of quality systems but also their proliferation.
For the third consecutive year Gateway had the pleasure of exhibiting at the AAPS Annual Meeting, which was held this year in San Antonio, at the very large Henry B. Gonzalez Convention Center. AAPS members and attendees come from a wide range of areas within pharmaceutical drug development and biopharmaceuticals. In addition to offering free popcorn daily and an open bar on Tuesday night, this year, our focus was to promote analytical services that not only support drug product formulation development but also address manufacturing issues such as particulate contamination and source determination.
Published in Inhalation Magazine’s (www.inhalationmag.com) August 2013 issue featuring Rebekah Byrne, Scientist and David Exline, Senior Vice President of Gateway Analytical
Original Event Date: Wednesday, November 20, 2013
Duration: 60 minutes
Presenters: Cara Plese, M.S., Scientist I, & Antonio Scatena, Laboratory Manager at Gateway Analytical
On September 18th, Rebekah Byrne, Scientist I and David Exline, Senior V.P. at Gateway Analytical hosted a webinar designed for professionals (e.g. Quality Control, Industrial Engineers) involved in the production and development of various materials, ranging from adhesives and polymers to plastics and glass. During this webinar, our presenters provided an overview of RCI and the type of data that can be generated using this technique. They discussed how this technique is currently being utilized in areas such as pharmaceuticals and provided details on how RCI can be beneficial for analyzing other types of materials, such as adhesives, polymers and coatings. They also discussed how analysis of materials using RCI can improve product development and failure analysis.
When everything within your quality system seems to be running like a well-oiled machine, it is easy to get stuck in a rut and perceive a lack of corrective actions or deviations as a signal that nothing needs to change. However, just because something works well does not negate the fact that it can be improved.
On August 28th, Cara Plese, M.S., Scientist I and David Exline, Senior V.P. at Gateway Analytical hosted a webinar designed for professionals (e.g. Quality Control, Industrial Engineers) involved in the production and development of tablet and semi-solid drug products. During this webinar, our presenters provided examples of commonly found contaminants in tablet and semi-solid drug products and how these contaminants are introduced into the manufacturing process. They presented a basic multi-tiered analytical approach to characterize foreign particulate matter and how to solve particulate contamination issues using a scientific approach. The importance of taking a pro-active approach to quickly source and manage contaminant issues in the manufacturing process to reduce the risk of future contamination was also discussed.
Original Event Date: Wednesday, August 28, 2013
Duration: 60 minutes
Presenters: David Exline, Senior Vice President & Cara Plese, M.S., Scientist I at Gateway Analytical
Host: Tifanie Tiberio, Event Coordinator at Gateway Analytical
On August 6th, Cara Plese, M.S., Scientist I and Antonio Scatena, Laboratory Manager at Gateway Analytical hosted a webinar designed for police and attorneys on the topic of condom lubricant analysis. During this webinar, our presenters provided an in depth explanation of the analysis of condom lubricants and gave insight into many of the variables that can influence the results of a test, including appropriate collection time, the location of sampling, and the type of condom used in an assault. The presenters focused on the results of condom lubricant analysis and discuss what can be determined once a sample has been tested.