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
Highlighted Topics Covered:
- Examples of commonly found contaminants in tablet and semi-solid drug products
- How these contaminants are introduced into the manufacturing process
- A basic multi-tiered analytical approach to characterize foreign particulate matter
- 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
Webinar Overview:
This webinar was 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 particle contamination 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.
Presenter Bios
David Exline
David Exline, Senior Vice President
Gateway Analytical
David Exline has more than 18 years of experience in managing and administering analytical laboratory and consulting services. Mr. Exline has helped companies establish cGMP laboratories and assisted pharmaceutical drug manufacturers to ensure that their cGMP facilities are compliant with FDA regulations. He is adept in numerous pharmaceutical-related services and testing methods including: materials characterization, particulate contamination analysis, particle sizing and high-resolution microscopy.Although familiar with analytical practices in several industries, Mr. Exline’s expertise lies in the pharmaceutical, materials science and forensic realms.
Cara Plese
Cara Plese, M.S., Scientist I
Gateway Analytical
Cara is experienced in performing analytical laboratory work, specifically performing characterizations of unknown materials, in both the pharmaceutical forensic and criminal forensic fields. She was trained and performs investigations in a quality-oriented environment, including both ISO and ASCLD/LAB accreditations. She performs analytical testing on a variety of sample types using various techniques including microscopy, SEM/EDS, FTIR, Raman and interprets results of testing and prepares reports.