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Articles by Vaisala

Vaisala


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New Webcast: Understanding USP 36
September 24, 2014

Please enjoy this 30-minute webcast from Mary G. Foster, PharmD., Chair of the USP Expert Committee, with Vaisala's Senior Regulatory Compliance Expert Paul Daniel as they review changes to the latest revision of USP <1079> and forthcoming changes to GDP.

NEW eBook: Strategic Cold Chain Management
July 30, 2014

Get this eBook on USP and EU GDP guidance, including the latest revisions from the U.S. Pharmacopeial Convention and Good Distribution Practices according to the European Commission. This PDF outlines simple, applicable recommendations on following the guidance, and forthcoming changes.

Good Practices for Calibrating and Managing Sensing Instruments Used in GxP-Compliant Applications
June 25, 2014

Created by Vaisala’s calibration experts, this eBook contains great information for new and expert metrologists managing instruments in GxP-compliant environments.

Vaisala Mapping Kit: The Quickest Route to Environmental Validation
June 25, 2014

Reliable data from stable sensors eliminates the need to re-run studies, open deviation investigations, and spend extra time reporting. Simply download the software, place the loggers, and begin your study.

NEW eBook: Using GAMP to Validate Monitoring System Software
May 27, 2014

Learn how to use the GAMP methodology to validate monitoring system software. This ebook describes a 10-step process to help ensure your environmental monitoring systems align with both your QMS and good practice as described by the ISPE. Also, learn about the category of system that best suits your qualification capabilities and how to manage costs and risks.

eBook: Troubleshooting Tips & Best Practices for Validation/Mapping
April 23, 2014

• Sensor placement: where, how many, and for how long? • Validation Master Plan checklist • Links to 1-hour webinars: Protocols, GMP Guidance, and Regulations on Validation

eBook: Troubleshooting Tips & Best Practices for Validation/Mapping
February 26, 2014

• Sensor placement: where, how many, and for how long? • Validation Master Plan checklist • Links to 1-hour webinars: Protocols, GAMP Guidance, and Regulations on Validation

5 Rules of Sensor Placement in Mapping Studies
January 29, 2014

This 1-hour webinar will outline 5 Rules for good sensor placement in environmental mapping studies, including how many to use in different types of environments. We review mapping guidance from ISPE that covers environments ranging from warehouses to table-top incubators and small refrigerators.

USP Guidance Chapters for Temperature-Controlled Supply Chains
December 18, 2012

This paper looks at the five general chapters of the updated and revised United States Pharmacopeia and The National Formulary (USP 33?NF 28) that touch upon the temperature-sensitive supply chain.

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Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
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