Newsletter | February 18, 2014

02.18.14 -- Janet Woodcock's Quality Agenda At CDER

Pharmaceutical Online Newsletter
Secura — Safe And Secure Weighing
Secura® gives you peace of mind in knowing that you have done everything right. Besides providing highly accurate weighing results and operating convenience, Secura® also features built-in protection systems for complete reliability and regulatory compliance — the safe and secure way. Real-time guidance prompts for leveling, automatic internal adjustment, and 100% traceable, clear documentation with sample and batch identifiers make your lab work more efficient. Learn more.
» Featured Magazine Article
Janet Woodcock's Quality Agenda At CDER
By Wayne Koberstein, Executive Editor
Speaking in whole sentences may become an ever-rarer practice in this, the “Abbreviated Age” of texts and tweets — but Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research (CDER), is someone who speaks in whole paragraphs. She is not reading from a script; she spontaneously composes succinct, lucid, and informative statements based on logic and knowledge, requiring none of the editing we usually expect with extemporaneous speech. Woodcock speaks with the perspective of a builder, not an observer. Over many years, she has helped shape and construct the agency as it is today. Consequently, she has become the most consistent, reliable voice of the FDA for most people in the life sciences industry.
Featured Focus: Manufacturing
Considerations When Selecting A Pharmaceutical Feeder To Reduce Manufacturing Costs
By Chad Lorensen, Schenck AccuRate
Metering dry powders in the pharmaceutical industry is not a new idea. Several common applications have been using gravimetric and volumetric dry material feeders for many years. Until recently, these feeders were customized versions of industrial or food-grade equipment, or one-off-type machines engineered for a specific application. Driven by increasing demand, an equipment manufacturer embarked on an effort to create a standard dry material feeder engineered to meet the pharmaceutical industry'’s needs.
ARTICLE: Which Is Best For Your Application? Comparing Instantaneous Microbial Detection Technology
APPLICATION NOTE: Replacing Activated Carbon With Zeta Plus Activated Carbon Depth Filter Cartridges In Pharmaceutical Applications
CASE STUDY: FOWS Washer-Sterilizers Case Study
BROCHURE: Benchtop Pharmaceutical Roller Compactor
SERVICE: Roller Compactor Rentals
» Inspection
WHITE PAPER: Weigh Loss Or Gain? Checkweighing In The Pharmaceutical Industry
By Laura Studwell, Loma Systems
Prices for pharmaceutical products have been increasing at an accelerated rate for more than a decade. The increases are being driven by increased product competition, coupled with the growing cost of research and development, the increase in patent laws, and greater government legislation, as well as the price transparency created by insurance companies worldwide.
WHITE PAPER: Robolux Valves And ELEMENT Control Heads: A Combination To Facilitate The Next Generation Of Plants
DATASHEET: Low Profile Hygienic Floor Scale: IF Series
By Sartorius Intec
VIDEO: Identify Contaminants For Fast Corrective Action
BROCHURE: Retort Pouch Inspection
» Critical Environments
WHITE PAPER: Top 10 Considerations When Selecting An Isolator Supplier
By Gary Partington, Walker Barrier Systems
While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier to be certain that you are getting what you are paying for, before the purchase order is written.
WHITE PAPER: How To Select An Appropriate Aqueous Cleaner
By Malcolm McLaughlin, Alconox, Inc.
What are important questions to consider when selecting an aqueous cleaner? Today's aqueous critical-cleaning detergents are blended for specific applications — substrate, degree of soil load, and cleaning process — these are all important considerations when selecting a detergent.
APPLICATION NOTE: Effective Cleaning Of BOD Bottles
SERVICE: Containment: Pharmaceutical Powder
PRODUCT: Pharmaceutical Cleanrooms: Barrier Walls And Panels
WHITE PAPER: Multivariate Data Analysis For Biopharmaceutical And Biotechnology
WHITE PAPER: A 15-Minute Guide To Compliant Document Management For Life Sciences
CASE STUDY: Striving For Label Perfection In Clinical Trials
PRODUCT: Comprehensive Training Courses In Freeze-Drying Technology
PRODUCT: Handheld Particle Counter: MET ONE HHPC 6+
» Packaging
ARTICLE: What To Know Before Initiating Product Packaging Changes For Gamma Processing
WHITE PAPER: A New HPMC Capsule For Optimum Formulation Of Pharmaceutical Dosage Forms
CASE STUDY: Vision System Enables ePedigree Solution
VIDEO: Press Out Semiautomatic Deblistering Machine
PRODUCT: Leak Testing Equipment For Packaging And Closure Containers
» Logistics
ARTICLE: Growing Freight Tonnage Equals Growing Cargo Security Concerns
CASE STUDY: Precise Cold-Chain Logistics Supports Global Study Of Heart Disease
DATASHEET: Southwest Airlines Cargo Capabilities
By Southwest Airlines Cargo
PRODUCT/SERVICE: Wireless Temperature And Humidity Monitoring System
PRODUCT: Off-The-Shelf Insulated Shipping Containers
INTERPHEX is the single source for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms of life-enhancing drugs. See, touch, and procure the latest technologies and innovations, March 18 to 20, 2014, at the Javits Center in New York City. For more information visit

Quality By Design (QbD): Successful Implementation For Pharmaceutical Development And Manufacturing
Date: Tuesday, February 25, 2014 • Time: 1pm – 2:30pm EST

Serialization Program Management And Governance: Defining Roles For Success
Date: Wednesday, March 5, 2014 • Time: 1pm – 2:30pm EST
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