Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

Extractable and Leachables for biological and high risk dosage forms presented by Catalent expert at the Eastern Analytical Symposium

SOMERSET, NJ, November 9, 2012 – Thomas Feinberg, Ph.D., Director, Development & Clinical Services, at Catalent Pharma Solutions will teach a course titled “Extractable and Leachables Studies for Biological and Other ‘High Risk’ Dosage Forms” at this year’s Eastern Analytical Symposium on November 14, 2012 at the Garden State Exhibit Center in Somerset, NJ

This content was written and submitted by the supplier. It has only been modified to comply with this publication’s space and style.

This course addresses the current state of regulatory policy related to leachables and potential leachables (i.e., extractables) organized as to drug product type.  The course will also cover laboratory evaluation of potential leachables (i.e., extractables), qualitative and quantitative analysis of leachables and extractables (for both stability studies and routine quality control), and safety evaluation of leachables within the context of an overall pharmaceutical development process with special emphasis on the sensitive nature of biologicals.

Dr. Feinberg is a Director in the Development & Clinical Services business of Catalent Pharma Solutions. He has over 15 years Pharmaceutical Analysis experience and over 25 years experience in Mass Spectrometry and Organic Spectroscopy. He was a co-author on the PQRI Working Group on Leachables and Extractables recommendation “Safety Thresholds and Best Practices for Leachables and Extractables in Orally Inhaled and Nasal Drug Products (OINDPs).” After completion ofthat project, Dr. Feinberg helped develop and conducted many of the PQRI training modules both in the US and Europe. He has been an active member of the PQRI Leachables and Extractables Parenteral Ophthalmic Drug Product (PODP) working group from its inception in 2008.  He has written and presented extensively on extractables and leachables issues and also on advanced analytical chemistry techniques for quantitation and characterization of pharmaceutical impurities, degradants and adulterants.

For more information on this course and to register, please visit www.eas.org.

Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Researched List: Blister Machines for Life Sciences
Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More
Pharmaceutical Innovations Report