Plenary Session 1: Introductory - Overview

Hear from FDA on their Regulatory Expectations and Review of survey results in comparison to last year’s responses.

Richard Johnson, PDA
Steven Wolfgang, FDA

Plenary Sessions 2 & 3: Development Considerations/Glass

This recording discusses several different facets of this phenomenon from a glass company perspective. Presenters address such topics as design, cause, risk factors, and new methods for detection as well as actions taken by glass manufactures to address the problem.

Session 2 presenters:

Carol Rea Flynn, Gerresheimer Glass, Inc.
Dan Haines, PhD, SCHOTT Pharma Services
Juan Cerdan-Diaz, PhD, Nipro Glass Americas
Mark Fitzgerald, Nipro Glass Americas
Justin Wright, PhD, BD Medical—Pharmaceutical Systems(Recording and handout are not authorized for distribution)
Boris Schmid, PhD, OMPI

Session 3 presenters:

Christophe Wagner, SGD
Ron Iacocca, PhD, Eli Lilly and Company
Christopher Weikart,PhD, SiO₂ Medical Products
Robert Langer,PhD, MIT

Plenary Session 4: Pharmaceutical Packaging in Glass

This recording discusses considerations for manufacturers, and methods for evaluation and best practices to avoid defect induction.

William Bogle, Genesis Packaging 
John G. Shabushnig, PhD, Pfizer, Inc.
Dave Machak, American Glass Research

Plenary Session 5: Glass Handling Equipment Manufacturers Perspective

This recording gives insights to state of the art and future concepts of container handling in primary and secondary handling operations and how these concepts improve the container stability.

Sigrid Lieb, Vetter Pharma
Mathias Kreher, Bosch
Jim Nadlonek, Bausch & Stroebel Machine Company, Inc.

Plenary Session 6: Quality Control Issues

This recording explores the impact of new compendial methodology and explores fracture analysis and particle analysis as an aid for problem solving glass quality issues.

Diane Paskiet, West Pharmaceutical Services
George Quinn, PhD, Consultant
Gretchen Shearer, PhD, The McCrone Group

Plenary Session 7: Distribution/Packaging/Transportation

This recording focuses on what glass suppliers are doing to prevent breakage during shipment to their customer. It also addresses what field data Pharma companies should be evaluating to ensure that they are performing the correct distribution testing during package qualification.

Shana Whitmore, Amgen, Inc.
Bryan Williams, Lansmont Corporation

Plenary Session 8: Monitoring Customer Feedback & Other Factors to Consider in Glass Defect Prevention

Case studies presented during this recording provide insight into actions taken to reduce glass defect complaints and measure customer satisfaction.

Catherine Gould, FDA
Krista Liotta, Merck and Company, Inc.
Maria Linzmayer, Merck and Company, Inc.

Plenary Session 9: What Are We Going To Do To Make It Better?

Case studies presented during this recording provide insight into actions taken to reduce glass defect complaints and other external factors to consider in the prevention of glass defects in sterile manufacturing and distribution operations.

Mihaela Simianu, PhD, Eli Lilly and Company

Panelists:

Roger Asselta, Genesis Packaging Technologies
Milind Ganjawala, FDA
Diane Paskiet, West Pharmaceutical Services
Steven Wolfgang, FDA

Contact

Jason E. Brown
Senior Manager, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org