• Who should attend? Pharma and biopharm executives who form and manage outsourcing partnerships.
• What's on the agenda? Educational sessions focused on best practices and industry leaders’ experiences and lessons learned to help you avoid costly mistakes.
Register today! Space is limited. Brought to you by Life Science Leader magazine, BayBio, and Outsourced Pharma.
By Joanna Gallant, Joanna Gallant Training Associates
“Every 483 observation has a training component.” Truer words have never been spoken — I only wish it was me who said them. An FDA inspector I heard at a conference almost 15 years ago made this statement, and it forever changed how I look at 483 observations. I'll admit up front that I have a bias toward training — after all, it's what I do. Others don't necessarily share that bias, being that often training isn't done well, isn't timely or effective, or isn't always meaningful. I've heard the arguments and can even agree with some of them. But let's set that aside for now and look at what the inspector meant.
By Eric Chiang and By Robert G. McGregor, Brookfield Engineering Laboratories, Inc.
Medicinal and pharmaceutical products that are applied by spraying have gained in popularity because they easily coat the targeted surface without need for further spreading action by the consumer. Oral and nasal sprays may actually work with greater rapidity, migrating quickly to the target area and producing a very desirable benefit for the patient in terms of faster relief. How do manufacturers know whether the spray will actually stick to the targeted surface once it arrives?
By Kevin Zarnick, Thermo Fisher Scientific
The U.S. Food and Drug Administration (FDA) issued the Prescription Drug Marketing Act of 1987 (PDMA), which was then modified by the Prescription Drug Amendments of 1992. Included was Section 503(e)(1)(A), which establishes the pedigree requirement for prescription drugs.
By Jens Voigtländer, Editor, Bürkert Werke GmbH
B. Braun Melsungen AG is one of the leading companies in the international pharmaceutical and medication sector. With an investment of 164 million Euros the company is currently building the LIFE Nutrition plant, one of the world's most modern production sites for innovative nutrition solutions, at the company headquarters in the North Hessian city of Melsungen.
By Hemi Sagi, Director, ATC, Inc.
Before new technologies were available to directly measure very small leaks, most leak measurements were done indirectly. Direct mass leak flow measurement has many advantages. It is independent of part volume or configuration, and it's not sensitive to temperature changes.
By A. Miller and J. Riter, SP Scientific
Residual moisture in elastomeric closures can cause degradation of lyophilized drug product. Prior to packaging the drug product, pharmaceutical manufacturers typically wash, steam sterilize and dry the closures.
By Paul Dupont, Ropack, Inc.
Global research on the pharmaceutical packaging market indicates that blister packaging will continue its robust growth, projected through the remaining decade to trail bottling only slightly in market share. While mature markets, such as Europe and Asia, already accept blister packs as a preferred method — and with North America stepping up its blister usage — these markets, surprisingly, are not the driving force in blister’s growth. Instead, the increase is expected, in large part, to be spurred by the benefits blister packaging brings to emerging markets where product protection, patient compliance, and the need for daily or weekly prescription dosages are often primary considerations.