Modern Quality Techniques Patient-centric Processes, Integrated QMS, Regulatory Intelligence (On-Demand)


Course Description:
For an organization to move to and thrive in a culture of quality involves having consistent, reliable, robust business processes and data that promote continual improvement and deliver on quality objectives. This webinar considers some of the most important aspect of quality management, including techniques to achieve a modern maturity model (QMM). We discuss potential areas of improvement, such as a patient-centricity focus, the accuracy and completeness of data, and how to meet current and future regulatory requirements.

Patient-centric mindset

  • Develop processes, products, systems with the patient in mind
  • Rapidly respond to patient feedback
  • Integrated data management strategy including a fully electronic quality management system (QMS)

  • Efficiency through data integration
  • Effective signal detection and response
  • Strong regulatory intelligence to support oversight responsibilities

  • Cost reduction through robust data gathering
  • Proactive preparation for impending regulatory changes
  • Who should participate:
    Drug manufacturing, pharmaceutical manufacturing, biologics organizations, medical devices; Job function: quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.

    The live version of this recording took place on September 13, 2023
    Access Duration:
    Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
    Though this course is being made available on USP’s Education site, the course content was developed by Pharmatech Associates, a USP company. USP has not independently reviewed or verified the accuracy of the course content.

    Speakers:Stephanie Gaulding, CQA, CPGP
    Managing Director, Pharmatech Associates – a USP company
    M.Sc. biotechnology, Johns Hopkins University
    B.Sc. biology, Virginia Tech

    Elaine Lee
    Senior Consultant, Quality Compliance
    Pharmatech Associates
    B.A. biology, San Jose State University