• Quality Risk Management And The Draft Annex 1 Revision — What To Expect

    The PIC/S Inspectors Working Group is preparing to finalize the EMA Annex 1, Manufacture of Sterile Medicinal Product, guidance/GMPs. The revision, an overhaul of the 2008 version of the annex, attempts to clarify many issues and concerns specific to aseptic processing of sterile medicinal products.

  • Quality Risk Management 101: Overcoming Common Challenges In QRM Implementation

    This article identifies and explores several challenges that permeate the industry as a whole — each of which poses a unique and very real challenge to the fully effective implementation of a quality risk management (QRM) program. It also explains the ways in which these challenges can sabotage QRM efforts.

  • Quality Risk Management 101: A Review Of Required Reading For QRM Practitioners

    Following the publication of ICH Q9, industry eagerly embraced the opportunity to share ideas and best practices related to QRM. This article focuses on selected publications addressing general, rather than specific, applications of QRM.

  • Quality Risk Management 101: QRM And The Product Life Cycle

    Quality risk management (QRM) is not a concept to be applied in a vacuum. Rather, it is a discipline that provides the most value when used throughout the product life cycle.

  • Quality Risk Management 101: ICH Q9 In Context

    ICH Q9, Quality Risk Management, represents the first internationally recognized guideline specifically addressing QRM for the pharmaceutical and biopharmaceutical industries, offering an overview of general QRM principles, an example of a risk management life cycle, discussion around the activities that occur in each life cycle phase, and a list of risk tools and quality system areas to which QRM can be applied.

  • Quality Risk Management 101: A Brief History Of Risk Management In The Regulation Of Medicinal Products

    This is the second in a series of six articles intended to provide a holistic primer on the field of quality risk management (QRM). This installment reviews the origins of pharmaceutical risk management and regulatory thinking that led to the establishment of QRM as a unique discipline in pharmaceutical development and manufacturing.

  • Quality Risk Management 101: Risks Associated With Medicinal Products

    This article marks the first of a series intended to provide a holistic primer on the field of quality risk management (QRM). The series will explore topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.


Kelly Waldron

Kelly Waldron is currently a senior consultant with ValSource and a member of the Pharmaceutical Regulatory Science Team (PRST) at the Dublin Institute of Technology in Dublin, Ireland. She has particular expertise and a specialized focus on the development and implementation of innovative approaches to quality risk management (QRM). Her expertise also extends to various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, including quality system design, quality strategy and planning, deviations/investigations, CAPA, change management, audit and inspection programs and response, stability programs, and design control. In addition, Waldron has authored numerous industry and academic papers on QRM. She has a BA in biology from Boston University, an MBA in pharmaceutical management from Fairleigh Dickinson University, and a Ph.D. in pharmaceutical regulatory science (thesis in QRM) from the Dublin Institute of Technology. She can be reached at