2011 PDA/FDA Glass Quality Conference & TRI Courses - Glass Issues in the News

Excerpts from FDA's “Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs”: “Glass has many advantages over other packaging materials, but one well-known disadvantage is the potential for glass under certain conditions to shed thin, flexible fragments called “glass lamellae.” “To date, no adverse events have been reported nor can any be directly attributed to this phenomenon. However, there is the potential for drugs administered intravenously that contain these fragments to cause embolic, thrombotic and other vascular events (e.g. phlebitis); and, when administered subcutaneously, to lead to development of foreign body granuloma, local injection site reactions, and increased immunogenicity.” “Accordingly, FDA advises drug manufacturers of products to re-examine their supplier quality management program with the glass vial manufacturers to assure that this phenomenon is not occurring.” “Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs.” Release date: March 25, 2011. For the complete advisory click here.

During this two-day 2011 PDA/FDA Glass Quality Conference & TRI Courses, industry and global regulatory authorities will discuss issues that resulted in product recalls, results of an industry survey on glass packaging supplier quality, and global regulatory perspectives and expectations of both the glass supplier and product manufacturer.

Participants at the completion of the conference will know more about:

•Current Issues with Glass Packaging

•Best Practices on Glass Handling

•Current Expectations for Incoming Glass and Pharmaceutical Product Packaging

•How to establish an effective Glass Supplier Relationship for Product Improvement

•Improvements in glass manufacturing, characterization, handling or packaging
All attendees will have the opportunity to be involved in discussions on what are we going to do to assure that the highest quality products and packaging are made.

Hear from these industry and regulatory professionals:

•Norman K. Angel, Gerresheimer Moulded Glass Americas Division

•Roger Asselta, Genesis Packaging Technologies

•Keith Bailey, Merck Sharp & Dohme Corp.

•Michael Baldwin, Bayer Healthcare

•Joyce Bloomfield, Merck Sharp & Dohme Corp.

•Tia Bush, Amgen

•Viviana Cambissa, GlaxoSmithKline

•Nicholas R. DeBello, Wheaton Industries, Inc.

•Theodore DeHaan, Gerresheimer Moulded Glass Americas Division

•Juan Cerdan-Diaz, Amcor Specialty Packaging, Glass Tubing Americas

•Dr. Michael Eakins, Eakins & Associates

•Mads Reedtz Espersen, Novo Nordisk A/S

•Mark Fitzgerald, Amcor Specialty Packaging, Glass Tubing Americas

•Dena Flamm, Bosch

•Dan Haines, SCHOTT North America, Inc.

•David Jaworski, FDA

•Richard M. Johnson, PDA

•Julia Lukas, Merck Sharp & Dohme Corp.

•Wesley Maharas, Eli Lilly and Company

•Jeffery Masten, Genentech

•Rob Miller, Pfizer

•Brian Mulhall, Whitehouse Analytical Laboratories

•Mark Paviglianiti, Merck Sharp & Dohme Corp.

•Anthony Perry, Schott Pharmaceutical Packaging North America, Inc.

•Boris Schmid, Stevanato Group

•Thomas Schoenknecht, PhD, Schott Pharmaceutical Packaging North America, Inc.

•John G. Shabushnig, PhD, Pfizer

•Rob Swift, Amgen

•Martin VanTrieste, Amgen

•Brian Wallin, Amgen

•Scott Young, PhD, West Pharmaceutical Services

Learn more
Register

P.S. On May 25 and 26 the PDA Training and Research Institute (PDA TRI) will be hosting two stand-alone courses to complement the learning from the conference. The courses include:

•Technical Report 43: Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing

•Selection and Utilization of Glass Containers in Pharmaceutical Packaging