Newsletter | August 21, 2014

08.21.14 -- What You Missed From The FDA Last Week

Pharmaceutical Online Newsletter
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PMMI has joined forces with ISPE to introduce Pharma EXPO 2014. Co-locating with PACK EXPO International in Chicago, November 2 to 5, Pharma EXPO answers the demand for a show focused on solutions for the entire pharmaceutical lifecycle. Register today to join as many as 10,000 pharmaceutical, biopharmaceutical, and medical device manufacturers for conference sessions and a bustling 80,000 net square foot exhibit floor.

Read more about the solutions that can be found at PharmaExpo: Scaling Up for Biopharmaceuticals.
» Featured Article
Timothy Tyson, Chairman And CEO Of Aptuit, Discusses Significant Changes In The Pharma Industry
By Gloria Hall, ISPE
The chairman and CEO of Aptuit speaks candidly about significant changes in the industry, his evolving leadership and management philosophy, ISPE’s role with influencing change in the industry, and the challenges for industry to increase productivity and reduce risk. 
Featured Focus: Inspection
How A Checkweigher Can Address Track-And-Trace Requirements For ePedigree Compliance
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.
CASE STUDY: Fumigation Within A Pharmaceutical Aseptic Filling Line
CASE STUDY: Medical Device Package Inspection
BROCHURE: X-Ray Inspection Systems
BROCHURE: Beckman Coulter Particle Size Analyzer
» Logistics
WHITE PAPER: Three Key Performance Indicators For Protecting Your Product
WHITE PAPER: The Reputational Risk Of Poor Cold Chain Visibility
CASE STUDY: A Robust Cold Chain With A Proactive Quality Improvement Approach
» QA/QC
WHITE PAPER: What Is Combustible Dust?
APPLICATION NOTE: Integration Of Remote Sensors Into Airborne Particle Counters To Monitor Critical Environments
BROCHURE: Bosch KKX 3900 Universal Capsule Inspection System
» Critical Environments
WHITE PAPER: The Role Of pH And Residue In Pharmaceutical Cleaning
By Malcolm McLaughlin, Alconox
A great deal is known about how pH affects aqueous critical cleaning. Typically, alkaline cleaners are used on oily residues and acidic cleaners are used on inorganic residues.
APPLICATION NOTE: Speeding Investigations Using Instantaneous Microbial Detection
PRODUCT: Single-Use Biopharmaceutical Powder Handling Equipment
» Packaging
CASE STUDY: Implementing Packaging Artwork Inspection Tools Helps Clondalkin Streamline Quality Control
DATASHEET: Blow-Fill-Seal Bottelpack type 360M
By rommelag USA, Inc.
SERVICE: Contract Packaging: Pharmaceutical Solid Dose Or Generics
» Manufacturing
DATASHEET: Pharmaceutical-Grade Washer
By STERIS Corporation
DATASHEET: Vertical Steam Sterilizers: FVG
By Fedegari Group
PRODUCT: Used Tablet Presses
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IQPC's 12th Annual Cold Chain GDP And Temperature Management Logistics Global Forum — taking place September 29 to October 3, 2014, at the Hynes Convention Center in Boston, MA — brings 750+ supply chain stakeholders together to discuss today's hottest topics in temperature control logistics for life sciences products, biotechnology, and quality management. The largest event of its kind in the world, which also features the largest exhibition of more than 120 solutions providers for temperature-controlled products, this is a must-attend! Not to mention the move to Boston, which provides access to new supply chain stakeholders. As a media partner for this event, Pharmaceutical Online subscribers are eligible for 20 percent off at registration. Quote code 12CCGF_PHARMAONLINE to ensure your discounted rate.
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Life Science Leader and BayBio bring you interactive panels on the challenges to managing outsourcing relationships. Panelists include Andy Skibo (RVP, AstraZeneca; EVP, MedImmune), David Lowndes (SVP, Shire), Bob Kanuga (VP, Merck), Junning Lee (SVP, Theravance Biopharma), Terry Novak (COO, Pernix Therapeutics), and others. Learn more.
» Most Recent News
Infitrak And Rapid Aid Announce Joint Development And Distribution Agreement To Deliver Cost-Effective Logistics Solutions For Temperature Controlled Markets
TNI Biotech And Hubei Qianjiang Expand Partnership
UK's NICE Recommends Gilead's Sovaldi For Hepatitis C
What You Missed From The FDA Last Week — August 11-15, 2014
Weekly FDA Enforcement Report For Drugs
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