DeGrazio to Speak at 2013 PDA/FDA Container Closure Components and Systems Workshop
West’s Fran DeGrazio, Vice President, Global Research and Development, will present, “QbD for Elastomeric Components – A Case Study” with Mihaela Simianu, Research Advisor, Manufacturing Science, Eli Lilly and Company, on Tuesday, May 14 at 10:30 a.m. at the 2013 PDA/FDA Container Closure Components and Systems Workshop.
The one-and-a-half day workshop will tie together a broad scope of attributes for container closure systems and the potential impact to quality of therapies from the point of component selection, to the manufacture of medicine and delivery to the patient. Discussion will touch upon packaging materials, components, delivery systems, human factors, supply chain and Quality by Design.
West’s Diane Paskiet co-chairs the program. Additional speakers include:
- Tom Forte, Senior Research Scientist, Battelle
- Ronald Forster, Director, Packaging Design/Engineer, Amgen, Inc.
- Dana Guazzo, PhD, President, Research & Development, RxPax, LLC
- Desmond Hunt, PhD, Senior Scientific Liaison, Standards Development, USP
- Donald Klein, PhD, Senior Reviewer Chemist, ONDQA, CDER, FDA
- Frederick Stearns, Partner, Keller Heckman Law Firm
- Kalavati Suvarna, PhD, Microbiologist, DMPQ, Office of Compliance, CDER, FDA
Prior to the workshop, PDA’s Training and Research Institute (PDA TRI) will hold the Essential Elements of Extractables & Leachables: From Material Selection to Final Report course. This course will demonstrate through examples and case studies the essential elements of the extractables and leachables process from the selection and evaluation of packaging materials to the writing of the study report – conversion of data to information.
For more information or to register, visit www.pda.org/containerclosure2013