Newsletter | December 10, 2013

12.10.13 -- 340B: A Game Plan for Success

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340B: A Game Plan For Success
By Nate Taninecz, Senior Director of Product Management at Model N
I recently had the pleasure to participate in a panel discussion at the 2013 HDMA Contracts and Chargeback conference, held at the historic Hotel Du Pont in Delaware. For two days, industry thought leaders educated the attendees on the challenges of the day.  There was one particular theme that was a conference highlight, and at the forefront of most attendees’ minds: 340B.

Compliance And Validation Requirements For Serialization: Keys To Success
Date: Thursday, December 12, 2013 • Time: 1pm – 2:30pm EST
Featured Focus: QA/QC
Review Of The FDA Guidance 'Codevelopment Of Two Or More New Investigational Drugs For Use In Combination'
By Seth A. Mailhot, Special Counsel, Sheppard Mullin Richter & Hampton LLP
On June 14, 2013, the FDA issued the guidance "Codevelopment of Two or More New Investigational Drugs for Use in Combination." The guidance discusses the FDA's recommendations for developing an entirely new combination therapy where none of the drugs to be used in combination have been previously developed.
ARTICLE: Is Your Lab As Safe As It Should Be? (Part 3 Of 4)
By Kelly Williams, Market Analyst
Headlines involving laboratory safety issues are not making the national news agencies, so the general population, as well as laboratory personnel, are not aware of the number of incidents that are actually occurring in laboratories. Lack of proper training certainly plays a role in these incidents, but most importantly, it is a lack of daily compliance to safe laboratory practices. Noncompliance is easy when you are not aware of the consequences. Because we are not hearing of these "lab incidents," it is easy to take shortcuts and not consistently follow standard lab protocols that ensure our safety. Constantly hearing about horrific traffic accidents keeps us clicking our seatbelts, so maybe if we were more aware of actual cases where negative consequences occurred because of lack of safety compliance we would make it a higher priority.
WHITE PAPER: Tips On Preparing For An FDA Inspection: Are You Following cGMP?
By Bruce McDuffee, Marketing Manager, Vaisala Life Science Division
If you're in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that must comply with current good manufacturing practice (cGMP), your facility will be inspected by the U.S. Food and Drug Administration (FDA).
APPLICATION NOTE: Determination Of Cell Aggregation In Bacteria Cultures For Contact Lens Disinfection Efficacy Testing
The percentage of aggregates in bacteria cultures may be determined by employing the Coulter Principle, also known as the electrical sensing zone (ESZ) technique. The ISO International Standard 13319 describes this technique.
APPLICATION NOTE: Meeting Regulatory Requirements For Vent Filtration On Water For Injection (WFI) Tanks
» Inspection
WHITE PAPER: Help Keep Pharmaceuticals Safe: Metal Detection Overview And Guidelines
By Kevin Zarnick, Thermo Fisher Scientific
Using metal detection as a means of identifying foreign object contamination has been prevalent in the food industry for decades. Although metal detection has also been in use to identify the presence of ferrous, nonferrous, or stainless-steel contaminants during the past 40 years in the pharmaceutical industry, it has not been as widespread.
WHITE PAPER: Eliminate Inspection Labor Costs On Your Blister Packaging Lines
By Giuseppe Bonfiglioli, Bonfiglioli Engineering SPA
Production of tablets and capsules is carried out in cleanrooms, and under stringent procedures, as per GMP requirements. However, the process also relies on machines and machine operators, whereby misappropriate handling can result in a faulty blister pack containing microleaks in the packaging that allows air and moisture to enter the blister and damage the product.
CASE STUDY: Sanico Boosts Tablet Inspection To 100 Percent
CASE STUDY: Avoid Product Recalls With Tablet Vision Inspection System
PRODUCT: Lyophilized And Powder Inspection Machine
» Manufacturing
WHITE PAPER: Does Rheology Matter To Manufacturing?
By Robert McGregor, Global Marketing and High-End Product Manager, Brookfield Engineering Laboratories, Inc.
You bet it does, whether or not manufacturing realizes it. Rheology is the science that looks at how materials flow. Whether the product is a liquid, cream, paste, or solid, the manufacturing process must transfer raw ingredients through multiple stages to create the finished product.
WHITE PAPER: Issues In Microfeeding
DATASHEET: Modular PODs™ For Bopharmaceutical Production And Containment
By G-CON Manufacturing
PRODUCT: Filter Systems For Pharmaceutical Separations
PRODUCT: Analytical And Laboratory Benchtop Instruments
PRODUCT: Pharmaceutical Dosing And Filling: API
PRODUCT: Complete Pharmaceutical Automation Systems
» Packaging
WHITE PAPER: Detecting Integrity Breaches In A Range Of Pharmaceutical Blister Package Types
By Dr. D. Dixon, University of Ulster
Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents.
SERVICE: Pharmaceutical Contract Packaging: Primary And Secondary Packaging Services
PRODUCT: Small-Volume Pharmaceutical Parenteral Packaging Systems
PRODUCT: Leak Testing Equipment For Packaging And Closure Containers
SERVICE: Cosmetic Contract Packaging: Sampling Stix
» Critical Environments
WHITE PAPER: Factors To Consider When Purchasing A Fume Hood
By Kelly Williams, Labconco Corporation
The process of finding the right fume hood can be a little complicated if you don't know the right questions to ask. You can save yourself a lot of trouble if you know the answers to these questions when you start shopping.
APPLICATION NOTE: Cleaning Of Cosmetic Creams And Lotions From Laboratory Glassware
DATASHEET: QUBE: Modular Workstation
By Bioquell Inc.
PRODUCT: Fluid Controls For Clean Steam Utilities
PRODUCT: FlexFill Single-Use Biocontainer Transfer Assembly
» Logistics
WHITE PAPER: The Urgent Need For Qualified Transportation Providers In Global Clinical Research
WHITE PAPER: Before Good Blood Goes Bad: Strategies To Saving Valuable Resources
CASE STUDY: A Medical Supply Company Opens The Door To Growth
PODCAST: Award-Winning Asset Tracking Solution Offers Customers More Options And Less Hassle
PRODUCT: Air Charter Management Services
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