Newsletter | April 15, 2014

04.15.14 -- Takeda And Lilly Hit With $9 Billion Penalty

Pharmaceutical Online Newsletter
Inspection QA/QC Logistics
Manufacturing Packaging Critical Environments
» Featured Guest Column
Questions All Auditors Should Ask: The Use And Misuse Of Audit Checklists
By Laurie Meehan, Polaris Compliance Consultants, Inc.
There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all-important question: "Why?"  How can you develop the best checklists possible and avoid relying on them too heavily?
Featured Focus: Inspection
How To Survive An FDA Audit
By Paul Dupont, Ropack
Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater access to records, and conducting audits more frequently — up from .06 to .09 per year, according to Bloomberg News.
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.
DOWNLOAD: Blister Leak Tester
PRODUCT: Used Automed Fastpak EXP 126 Pharmaceutical Automated Tablet Machine
PRODUCT: Leak Testing: Empty Bottles And Containers
WHITE PAPER: Biological Contamination Management In Aseptic Environments: Requirements And Expectations
By James Drinkwater, Bioquell Inc.
Biocontamination found in critical zones within processing environments can affect the whole process and sterility of the final products, potentially putting patients at risk. This can lead to significant financial costs and impact operational resources.
WEBINAR: Guidelines For Good Density Measurement
DATASHEET: AeroTrak Remote Particle Counter
By TSI Incorporated
SERVICE: Pharmaceutical Manufacturing Operations Investigation Services
PRODUCT: Cell Counter For Cell Viability Analysis
» Logistics
WHITE PAPER: Validation/Mapping Applications: Troubleshooting Tips And Best Practices
By Paul Daniel and Jon Aldous, Vaisala
The FDA mandates the validation of environmental conditions that can affect the strength, identity, safety, quality, and purity of pharmaceuticals, medical devices, or biologics. To meet these requirements for temperature or humidity, we perform a mapping validation, usually as part of an installation qualification and operational qualification of the environment, whether it is incubator, fridge/freezer, stability chamber, cold room, or warehouse.
WHITE PAPER: The Benefits Of Smart Camera Vision Systems For Serialization And Track And Trace
By John Lewis, Market Development Manager, Cognex Corporation
As pharmaceutical manufacturers confront increased margin pressure in the coming years they will look for new ways to lower their costs to install and maintain production lines. Having the option to choose smart camera vision systems instead of being locked into PC-based vision systems at the machine level can be a tremendous advantage that often results in a solution that’s less expensive to install, less complex to validate, and less costly to maintain.
DATASHEET: RAP e2 Container: Temp-Controlled Containers For Extreme Requirements
By Envirotainer
PRODUCT: Hand-Held Vaccine Carriers: AcuTemp PX1L
» Manufacturing
APPLICATION NOTE: A Mesoporous Silica Carrier Optimized For Liquisolid And Lipid-Based Formulations
DATASHEET: Reduce Your Purification Costs With SciPure TFF And NFF Systems
By Parker domnick hunter Process Filtration
VIDEO: One-Inch Sterile Connectors For High-Flow Applications
BROCHURE: Synchronized Outsourced Solutions
PRODUCT: Pharmaceutical Homogenizer Applications
PRODUCT: Commercial HVAC Filters
» Packaging
CASE STUDY: Meeting Technical Challenges In Desiccant Dispensing
SERVICE: Sterile Manufacturing And Packaging Services
DATASHEET: Filling And Mounting Of Inhalers With Dosed Powder Filling (MDPIs)
By Harro Höfliger Packaging Systems
PRODUCT: Capsule Filling System With Checkweigher System Integration
PRODUCT: Pharmaceutical Isolation Systems For Blow/Fill/Seal Equipment
» Critical Environments
DATASHEET: Buckhorn Reusable Intermediate Bulk Containers
By ILC Dover
BROCHURE: Custom Isolators And Containment Systems
PRODUCT: Isolators For Potent Or Hazardous Compounds
PRODUCT: Chamber Washing Systems
PRODUCT: Modular Pharmaceutical Cleanroom Pass-Throughs

Effective Investigations And Root Cause Analysis: A Step-by-Step Guide for Manufacturers
Date: Wednesday, April 30, 2014 • Time: 1pm – 2:30pm EST
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