05.20.14 -- FDA Lifts Restrictions On GSK's Avandia; Three Questions To Consider For DQSA Readiness

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Three Questions To Consider For DQSA Readiness
By Dave Colombo and Dawn Wang, KPMG Life Sciences Advisory
Last November, after much anticipation, the U.S. pharmaceutical industry saw the enactment of the Drug Quality and Security Act (DQSA), which includes in Title II the Drug Supply Chain Security Act (DSCSA). The DSCSA addresses national pharmaceutical track and trace requirements, and industry stakeholders must now prepare themselves for the first round of deadlines for lot-level traceability starting January 1, 2015. In preparation for these guidelines, it is important for companies to follow a framework as they assess their organizations’ readiness to meet DSCSA compliance. A successful program will do so by evaluating the impacts to their business processes and governance, technical solutions, and trading partner relationships.
Featured Focus: Packaging
Serialization And The Drug Quality And Security Act: A Top-Down Synergistic Approach
By Mike Salinas, et al., M+W Group
Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly turn to both the global dilemma of safeguarding the public from the proliferation of counterfeit drugs and the Drug Quality and Security Act (DQSA).
DATASHEET: Custom Handling Of Tablet Blisters (Tray Loading And Unloading)
By Harro Höfliger Packaging Systems
VIDEO: Primary And Secondary Pharmaceutical Packaging Services
SERVICE: Blow/Fill/Seal Design Services And Prototyping
» Inspection
WHITE PAPER: Streamlining Particle Count Data Management
By Paul Yates, Beckman Coulter Life Sciences
Pharmaceutical cleanrooms have gone through drastic changes in recent years as mergers, acquisitions, facility closures, drug patent-cliffs, and other industry dynamics have forced manufacturing facilities to continually adapt to remain both competitive and compliant with the U.S. Food and Drug Administration (FDA) regulations.
DATASHEET: INSIGHT HD Tunnel Metal Detectors
By Loma Systems and Lock Inspection
PRODUCT: Tablet Visual Inspection With Color And 3D High-Speed: TVIS-EX3CD
WHITE PAPER: Flexible Measuring And Control In Reverse Osmosis Systems
By Christof Kundel, Segment Manager Water Treatment, Bürkert Fluid Control Systems
Reverse osmosis systems play a central part in water treatment. In industrial applications, for example, reverse osmosis is used for purifying process water, producing drinking water, desalinizing seawater, or for producing ultra-pure or pharmaceutical water. In addition to these processes, which are aimed at reducing the concentration of the substances dissolved in the water, the beverage industry also uses reverse osmosis systems for increasing concentrations, e.g., in the manufacture of fruit juice concentrates or for concentrating the must in wine production.
COURSE: Basics Of Tablet Manufacturing And Troubleshooting
PRODUCT: Pharmaceutical Air Quality Monitoring
» Critical Environments
WHITE PAPER: How To Reduce Cleanroom Costs
By Alex Verayo, Terra Universal
As cleanrooms grow in size and sophistication, energy demands go up significantly. Even worse, 24/7/365 operation puts substantial particulate loads on filters, increasing maintenance costs and possibly causing unpredictable — and expensive — cleanroom maintenance shutdowns.
DATASHEET: Zone Biodecontamination System
By Bioquell Inc.
PRODUCT: Solujet: Low-Foaming, Phosphate-Free Liquid Detergent
» Supply Chain
WHITE PAPER: Generating Value From Continuous Data Flows And How To Manage The Data
DATASHEET: Certis GPS-RP Pallet Shipper
PRODUCT: Thermal Pharmaceutical Shipping Container For Smaller Payloads
» Manufacturing
WHITE PAPER: What Is Homogenization?
APPLICATION NOTE: Recommended Mixing Equipment For Pectin
BROCHURE: Bosch Isolation Systems

Renovating Pharmaceutical Manufacturing Facilities For Aseptic Fill/Finish: Critical Planning, Execution, And Compliance Tips
Date: Tuesday, May 20, 2014 • Time: 1pm – 2:30pm EST

Authoring And Implementing Standard Operating Procedures (SOPs): Best Practices For Success
Date: Wednesday, May 21, 2014 • Time: 1pm – 2:30pm EST

The Vendor GMP Qualification Audit: Ensure Your Vendors Meet Your Compliance Standard
Date: Tuesday, June 3, 2014 • Time: 1pm – 2:30pm EST
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