Glass Breakage Analysis and Fractography

Roger has nearly thirty years working in the area field of injectable drug packaging.  He has held management and executive positions in production quality and technical development. He joined Genesis Packaging Technologies in 2006 as Vice President of Technical Affairs and Senior Advisor.  Roger teaches courses on pharmaceutical packaging including courses on pharmaceutical glass quality and vial sealing and integrity. He is the 2017 recipient of the PDA’s Packaging Science Award. He is also a member of the American Society for Quality and American Society for Testing and Materials.  Roger has written and presented on several aspects of pharmaceutical container/closure systems, including glass technology and container closure integrity. Roger has three patents for parenteral packaging systems.  He holds a B.S. in Biology from Maine’s Nasson College and received a graduate certificate in quality management from Pennsylvania State University.

25 years of experience in the Glass Manufacturing and Pharmaceutical Industries. Recognized as Eli Lilly and Co., “Global Glass Expert.” Led numerous cross-functional teams in the U.S., Europe, Mexico and China in the resolution of glass breakage investigations. Subject Matter Expert for glass containers on global internal and external supplier - Six Sigma teams on projects to:

• improve inspection practices and equipment
• effectively perform breakage investigations
• reduce defects and increase yields
• glass quality improvement initiatives with suppliers

Led the development of, and delivered training to hundreds of colleagues in basic and advanced glass handling and breakage investigation practices in the U.S, Europe, Mexico and China. Project leader for a new method to reduce glass defects that are created during transportation. Led the development of a collaboration site/Blog in order to provide colleagues interactive resources and support to learn about glass science and breakage.

Paul Harber is founder of Parenteral Supply Chain, LLC. PSC, as it is known, collaborates with clients devoted to all facets of the distribution of parenteral products.

Paul Harber was a Principal with Modality Solutions, LLC. He completed work with a variety of companies in the Life Science areas. The scope of work has ranged from validation of active and passive shippers for numerous pharmaceutical clients as well as the installation and qualification of the Transport Simulation Lab located at BioConvergence. In 2014, project work with NGOs in the evaluation of cold chain operations at Ebola vaccine clinical trial sites in Zone 4 countries was a personally rewarding addition to scope of work.

Paul Harber was a founding member of the PDA Pharmaceutical Cold Chain Interest Group. Paul co-authored for the Parenteral Drug Association (PDA) Journal of Pharmaceutical Science and Technology Technical Report No. 39 (PDA TR#39). PDA TR#39 is widely used by both industry professionals and regulators as the definitive reference source for best-demonstrated practices in transport validation. For 16 years, the scope of Paul’s work at Eli Lilly and Company focused on the qualification of both active and passive shippers in support of clinical and commercial transportation of temperature labile products. He had major roles in defining and specifying the cold chain components and practices necessary to support the commercialization of four Lilly products worth over one billion in annual sales. Paul was the interface to all regulatory agencies on issues of transport package qualification. Paul has provided tech transfer support to implement numerous changes and improvements across the supply chain in support of the Lilly API supply strategy. As a team member on the internal Lilly CM&C teams, Paul made major contributions in the selection and justification of primary packaging as well.

Paul is the 2008 recipient of Eli Lilly Engineering Excellence Award, a peer selected award acknowledging lifetime engineering achievements at Eli Lilly and Company.

Nearly 50 years of experience in fractography of glass (research, teaching, consulting) including more than twenty years teaching (with George Quinn) the Alfred short course on “Fractography of Brittle Materials.” An Honorary Member (Ehrenmitglied) of the German Society of Glass Technology (Deutsche Glastechnische Gesellschaft), a Fellow of the American Ceramic Society, Kruson Distinguished Professor of Ceramic Engineering at Alfred University, member of Phi Beta Kappa and Phi Kappa Phi, recipient of SUNY Chancellor’s Award for Excellence in Faculty Service.