on 'Regulatory Guidance'

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  • A DSCSA Checklist — Are You Ready?

    The DSCSA enforcement is fast-approaching and the pressure is on pharmaceutical manufacturers and distributors to adapt their processes.

    Gina Parry, national account manager, VAI
  • What Biotech Brands Need to do After Mergers

    This year could be explosive for biotech mergers. Here are some critical strategies to seamlessly transition two companies into one.

    Mark McGregor, Senior Vice President of Strategy, Signavio
  • The Blockchain Boom

    How the emerging technology could be pharma's savior from costly regulations and counterfeit drugs.

    Meagan Parrish, Senior Editor
  • Trailblazing Women in Pharma History

    From critical scientific breakthroughs, to “tough-as-nails” leadership, here are some of the women who have shaped the pharmaceutical industry.

    Meagan Parrish, senior editor
  • EU FMD: The One-Year Countdown

    Companies that manufacture, sell or dispense drugs in the European Union have until February 9, 2019 to comply. Where does the industry stand?

    Pharmaceutical Manufacturing staff
  • Reg Vision

    A painless look inside the most impactful regulatory trends and actions from 2017

    Karen Langhauser, Chief Content Director
  • Regulatory Intelligence Brief: 2017 FDA Overview

    All the major changes this year including guidance documents drafted and finalized, new legislation, other areas of interest and some tools to help you explore additional areas not covered herein

    Meredith Brown-Tuttle, RAC, FRAPS, Principal Consultant, Regulatorium
  • Keeping it Real – The Fight Against Fake Drugs

    With estimates of counterfeit drugs representing between eight and 15 percent of all medicines sold worldwide, pharmaceutical manufacturers need to stay ahead of counterfeiters

    Sean Riley, Senior Director, PMMI, The Association for Packaging and Processing Technologies
  • Identifying Contaminants in Pharmaceutical Manufacture

    In-process testing for contaminants is only as good as the methods used, so employing carefully developed and validated protocols is essential

    Gayla Velez, general manager, laboratory services, SGS Lincolnshire
  • Specifying Instruments to Meet Pharmaceutical Hygienic Requirements

    Industry standards help guide process instrument selection in pharmaceutical and biotech manufacturing environments, but further judgment is often required

    Ron Pozarski, senior industry manager, Emerson Process Management; and Emily Saopraseuth, product manager, Rosemount Pressure
  • MES Systems Help Facilitate Modern Regulatory Compliance

    Pharmaceutical manufacturers are eliminating the use of paper batch records in favor of electronic batch recording and Manufacturing Execution Systems

    Lars Hornung, senior director global sales, Werum IT Solutions GmbH
  • Managing Regulatory Inspections: A CDMO Perspective

    Inspection success begins with awareness of the challenges and obstacles, and continues with ongoing preparation and frequent inspection readiness

    Joachim del Boca, VP of Regulatory Affairs/Quality Compliance, Vetter Pharma-Fertigung GmbH & Co. KG
  • A New Day for Process Validation and Regulatory Review

    Drug Approval Strategies in the Age of Fast Track, Breakthrough Therapy and Accelerated Approval

    Tracy TreDenick, Head of Regulatory and Quality, David M. Fetterolf, Senior Consultant, Technical Operations and Michael Boyne, Senior Consultant, Analytical Services, BioTechLogic, Inc.
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