Newsletter | September 2, 2014

09.02.14 -- Janssen To Acquire Covagen And FynomAb Technology; What You Missed From Regulatory Agencies Recently

Pharmaceutical Online Newsletter
The Cold Chain GDP And Temperature Management Global Forum

Top 10 Temperature Management Trends for 2014
The Cold Chain GDP & Temperature Management Global Forum is dedicated to examining the latest life sciences trends: modern cold chain, supply chain integrity, and global GDP requirements.

2014 Guide To Global GDP Guidelines
There is no single global GDP standard, this guide includes a map that highlights the latest national, regional and organizational guidelines, with links to the source documents.

Future Of The Cold Chain Industry Survey Results
Sonoco Thermosafe's Future of the Cold Chain Industry survey: the results will be fully released at the 12th Annual Cold Chain Global Forum in Boston, from September 29 to October 3.

» From The Editor
Got Surplus? How To Implement An Asset Management Program For Your Surplus Laboratory Equipment
By Tom Burton, president and EVP of Liquidity Services’ Capital Assets Group
A variety of factors can result in obsolete laboratory equipment and R&D devices. Between budget restrictions and the need to adhere to fiscal and environmentally sound business practices, organizations can’t afford to allow surplus assets to lie idle or dispose of them in traditional ways. Surplus requires an innovative and sustainable process that supports strategic business goals.
Featured Focus: Manufacturing
How Ready-To-Use PAT Solutions Allow Pharma To Achieve Efficiency And Reduce Costs
By Dan Kopec, Sartorius Stedim Biotech
Process Analytic Technology (PAT) can be summarized as a driver for change from "status quo" offline laboratory analytics for data collection and subsequent post-process analysis to "dynamic," online monitoring and real-time decision-making with automated control.
WHITE PAPER: Modular Does Not Always Mean Flexible For Pharmaceutical Facilities
By Maik W. Jornitz, president, G-CON Manufacturing
Lately, the pharmaceutical industry has become increasingly interested in flexible facilities.
APPLICATION NOTE: Cleaning A Ribbon Blender
» QA/QC
CASE STUDY: Validation Strategy For A Sterility Testing Isolator Project
By James R. Rickloff, partner/scientific director, Advanced Barrier Concepts, Inc.
This document provides an overview on how to properly validate sterility test isolator systems and then, via a case study, describes a strategy for streamlining the validation process when equivalent isolators and/or generators are installed in a sterility test suite.
PRODUCT: Electrokinetic Analyzer For Solid Surface Analysis
PRODUCT: Non-Destructive In-Line Leak Tester For Vials
» Logistics
WHITE PAPER: A Model For Pharmaceutical Supply Chain Quality Agreements
By Rafik H. Bishara, Steve Jacobs, and Dan Bell
Over a decade ago, the way business was conducted between pharmaceutical manufacturing companies and their supply chain providers was typically expressed through verbal expectations at the due diligence meeting, at the audit, or at the first project meeting, and they were pretty much done by written bullet points.
WHITE PAPER: Safeguarding The Global Pharmaceutical Supply Chain
DATASHEET: Reusable Temperature Management Carrier
By CSafe Global
» Packaging
CASE STUDY: How Sanofi Will Save $3 Million In Packaging Costs
PRODUCT: Leak Testing Equipment For Packaging And Closure Containers
PRODUCT: Metal Detector And Checkweigher Combo System
» Inspection
APPLICATION NOTE: Procedural Reliability In Pharmaceutical Production
DATASHEET: High-Performance Portable Raman Analyzer: EZRaman-I
By TSI Incorporated
BROCHURE: Versa Rx High-Accuracy, High-Rate Checkweigher
» Critical Environments
PRODUCT: Bio-Decontamination Of Sterility Testing Systems
PRODUCT: Rapid Biologic Detection System For Air
PRODUCT: Glove Tester For Isolators
UPCOMING TRAINING

Vendor Qualification And Compliance: What Sponsors And CMOs Must Know
Date: Wednesday, September 17, 2014 • Time: 1:00 pm to 2:30 pm EST

Qualifying Your Trainers — What Do They Need For Your Training To Be Effective?
Date: Tuesday, September 30, 2014 • Time: 1:00 pm to 2:30 pm EST

Authoring And Implementing Standard Operating Procedures (SOPs): Best Practices For Success
Date: Wednesday, October 1, 2014 • Time: 1:00 pm to 2:30 pm EST
» Most Recent News
Novo Nordisk Acquires Manufacturing Facility From Olympus Biotech
New and Updated Drug Shortages List 8/27/14
What You Missed From Regulatory Agencies Recently — August 18 To 28, 2014
Janssen To Acquire Covagen And FynomAb Technology
Hera Therapeutics Presents Antiviral Drug For HPV
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