Newsletter | May 15, 2014

05.15.14 -- The FDA's Focus On Metrics, Performance, And Quality

Pharmaceutical Online Newsletter
» Guest Column
The FDA's Focus On Metrics, Performance, And Quality
By Ellen Leinfuss, SVP and Life Science practice leader, UL EduNeering
At the PDA Quality Metrics Conference in December 2013, FDA CDER (Center for Drug Evaluation and Research) Director Janet Woodcock set out her goals for the conference: “to shift [the FDA’s] focus to performance and away from compliance.” Under the FDA’s lead, the life sciences community will have no choice but to follow suit in its own operations and approaches to quality.
Featured Focus: Manufacturing
5 Questions To Ask Yourself Before Purchasing A Containment System
By Gary Partington, Walker Barrier Systems
If you are considering purchasing one, here are five questions to answer that will help you prepare before contacting or working with a containment system vendor.
WHITE PAPER: Comparison Of Paracetemol Tablet Formulations
APPLICATION NOTE: Double Planetary Mixing And Drying Of Granulations For Vitamin And Mineral Supplements
CASE STUDY: Roller Compaction Solutions For Pharma Manufacturing
PODCAST: 3M Moves From Upstream Clarification To Improving Efficiencies In Downstream Purification
» Supply Chain
WHITE PAPER: Managing The Complexities Of Global Supply Chain
By Kevin Lee, DPT Laboratories
With the increased globalization and accompanying complexity of the pharmaceutical supply chain, managing the role of materials sourcing has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve.
WHITE PAPER: Integrated Telemetry — The Pro-Active Cold Chain
VIDEO: Reliable, Low Cost Bio-Medical Carrying Case
» Critical Environments
APPLICATION NOTE: Cleanroom Requirements, Certification And Monitoring Per Common Accepted Standards
By Sean Birch, Applications Engineer, Lighthouse Worldwide Solutions
Cleanroom Classification and class limits are established in ISO 14644-1, while specifications for testing and monitoring to prove continued compliance are established in ISO 14644-2.
PRODUCT: Multi-Purpose Hydrogen Peroxide Vapor (HPV) Generator: Bioquell L-3
PRODUCT: Cleaning Validation (21 CFR Part 211.67)
PRODUCT: Manual-Visual Inspection: Pre-Filled Syringes, Vials, Ampoules, And Cartridges
PRODUCT: Laboratory Glassware Washing Unit
» QA/QC
APPLICATION NOTE: Automated Cord Blood Cell Viability And Concentration Measurements Using The VI-CELL XR
By Stephen E. Szabo, Ph.D. and Sarah Monroe, B.S., Beckman Coulter, Inc.
Stem cells, due to their differentiation into mature blood cells, are the key to successful bone marrow transplantations. More recently, it has been found that umbilical cord blood is also a plentiful and rich source of hematopoietic stem cells.
ARTICLE: Liquid Dosage Best Practice: Measuring Viscosity Of Small Samples
VIDEO: Inline Viscometer For Around-The-Clock Viscosity Monitoring
VIDEO: Siemens Industry SIPAT: Proven, Future-Proof Solution For PAT
WEBINAR: Digital Signatures: Enabling Compliant Collaboration And Streamlined Corporate Governance
» Inspection
DATASHEET: HeavyWeight Checkweighers: Bags Or Cases Up To 12KGs
By Loma Systems and Lock Inspection
VIDEO: Vision-Based Leak Detector
PODCAST: Solving The Need For Powder Characterization
PRODUCT: 360 Degree Inspection For Unoriented Cylindrical Packages: OmniView Series
PRODUCT: Metal Detector And Checkweigher Combo System: CoSYNUS
» Packaging
DATASHEET: Semi-Automated Packet Dispenser: APA-500
By Multisorb Technologies
DATASHEET: Automatic Inline Filling Machine
By Filamatic
VIDEO: Patented Technology Combines With Superior Cleaning Performance
BROCHURE: Accelerate The Drug Development Process: Licaps Fusion Technology
PODCAST: Risks Of Pinholes And Leaks In Pharmaceutical Containers
» Most Recent News
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Actinium Partners With IBA Molecular To Manufacture Iomab TM-B
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