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The West Blog

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Gamma Sterilization Process DMFs Harmonized

West Regulatory Affairs (RA) has a goal of harmonizing site-specific Drug Master Files (DMFs) into a global document as the processes at different facilities are synchronized.

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Janet Gaboury, PhD

Sr. Specialist Regulatory Affairs

Westar Sterilization Process DMFs Pharmaceutical Gamma Sterilization Process

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March 29, 2019

Simplify the Journey™ - Regional and Westar Wash Processes

Jia Min Boo

Specialist, TCS, AP

Westar Select Components Westar Wash Process

August 27, 2018

Westar® Select Components – Moving Toward Global Harmonization

Andy Polywacz

VP, Quality & Regulatory Affairs

Westar Select Components Quality Global Harmonization

July 19, 2018

West Celebrates Official Opening of New Global Manufacturing Facility in Waterford, Ireland

Deirdre Swinden

Director, Marketing Communications

Westar components Manufacturing Facility

December 05, 2017

Best Practices in Sterilization of Rubber Articles

Bjoern Henze

Manager, TCS Commercial, EU

Sterilization Components Westar

August 13, 2015

Regulatory Affairs a Competent Partner Helping to Ensure Regulatory Compliance

Jeanette Hampe

Regulatory Affairs Specialist

Regulatory Affairs Daikyo Crystal Zenith NovaPure Westar

April 16, 2014

New FDA Guidance Issued for Annual Reportable Changes

Steve LoCastro

Director, Regulatory Affairs

FDA guidance manufacturing westar

March 05, 2014

Steam-Sterilized Components with FluroTec® Barrier Film Technology May Aid Biosimilars

Tibor Hlobik

Sr. Director, Marketing, PFS

biosimilar elastomer extractables flurotex NovaPure plunger prefilled syringe westar

February 20, 2014

Understanding the Requirements for Ready-to-Sterilize Stoppers

West Technical Operations

components elastomeric ready-to-sterilize stoppers westar

February 18, 2014

Drug Shortages in Generic Injectables: Solving the Quality Issue

Erin O'Brien

Sr. Director, Marketing, Vial Containment

Drug Shortage Envision NovaPure Patient Westar

November 25, 2013

Meeting the High-Quality Demands of Sensitive Drug Products

Tibor Hlobik

Sr. Director, PFS, Marketing

Components Envision NovaPure PFS Prefilled Syringe QbD Westar

November 20, 2013

A Component Solution for Risk Reduction

Tibor Hlobik

Sr. Director, PFS, Marketing

Components PFS Westar

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The West Blog

Gamma Sterilization Process DMFs Harmonized

{1}

Simplify the Journey™ - Regional and Westar Wash Processes

Westar® Select Components – Moving Toward Global Harmonization

West Celebrates Official Opening of New Global Manufacturing Facility in Waterford, Ireland

Best Practices in Sterilization of Rubber Articles

Regulatory Affairs a Competent Partner Helping to Ensure Regulatory Compliance

New FDA Guidance Issued for Annual Reportable Changes

Steam-Sterilized Components with FluroTec® Barrier Film Technology May Aid Biosimilars

Understanding the Requirements for Ready-to-Sterilize Stoppers

Drug Shortages in Generic Injectables: Solving the Quality Issue

Meeting the High-Quality Demands of Sensitive Drug Products

A Component Solution for Risk Reduction

Press Releases