Article Archives

  • Register Today: Innovative, Interactive QC Microbiology Training

    Thursday, February 07, 2019
    Boston, MA Area May 7-9, 2019
    Carlsbad, CA Area Sep 10-12, 2019

    Expand your knowledge on:
  • Relevant USP regulations
  • How to apply the USP
    • ... read more

  • Registration Closing: FT-NIR Applied to Bioprocess Monitoring in a cGMP Environment

    Monday, May 16, 2022
    In this webinar, you'll learn about how the use of NIR as a process monitoring method in a cGMP environment adds additional requirements for PAT ... read more

  • Registration is now open for Eurofins’ E&L Symposium

    Monday, October 11, 2021
    Join us for a half-day, virtual seminar on October 27, focused on the various, complex aspects of Extractables & Leachables Testing. Industry experts ... read more

  • Regulating the Shift: Quality and Compliance in Decentralized Drug Production

    Monday, April 14, 2025
    Technology is driving a fundamental shift in pharmaceutical and biotechnology manufacturing. For the first time, advanced mobile and modular platforms... read more

  • Regulatory Affairs Professionals Society (RAPS) Honors 2014 RAPS Fellows

    Tuesday, October 07, 2014
    The Regulatory Affairs Professionals Society (RAPS) today honored its 2014 class of RAPS Fellows during the opening session of 2014 RAPS: The ... read more

  • Regulatory and Quality Considerations for Raw Material Identification by Portable, Handheld, and Miniature Spectrometers in the Manufacture of Drug Products and Compounded Sterile Preparations

    Sunday, February 05, 2017
    Portable, handheld, and miniature spectrometers are ubiquitous in the marketplace now. The possibility of instituting a raw material identification ... read more

  • Regulatory Changes Affecting Pyrogen Testing with the Monocyte Activation Test

    Friday, October 31, 2025
    Pyrogens represent a broad family of molecules that, when present in parenteral drugs, may induce adverse reactions in humans, ranging from fever to ... read more

  • Regulatory Considerations for the Development of Novel Antibody-Related Products

    Saturday, April 30, 2016
    Since the development of anti-diphtheria antitoxins in the 19th century, researchers and physicians have investigated antibodies due to their ... read more

  • Regulatory Expectations on Lifecyle Approach to Process Validation

    Wednesday, October 20, 2021
    Process validation is required, in both general and specific terms, by the cGMP regulations in parts 210 and 211, and is a legally enforceable ... read more

  • Regulatory Pseudoscience – Myths, Opinions and Other Fantasies

    Monday, April 13, 2026
    When regulations contradict the natural laws of science, they may impose a substantial hardship on manufacturers. read more

  • Regulatory Submissions for Rapid Microbiological Methods (RMMs)

    Tuesday, August 01, 2023
    More than twenty years ago, companies started introducing rapid microbiological methods (RMMs) to the industry. Some call these methods alternative ... read more
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