2017 ISPE/FDA/PRQI Quality Manufacturing Conference

Proactive Approaches to Facility and Life Cycle Quality Management Workshop

Jim McGlade, Science Client Leader for BHDP Architecture, led the “Proactive Approaches to Facility and Lifecycle Quality Management” Workshop. “What’s an architect doing in life cycle quality management?” he joked. “Although this is not my expertise, I’ve been designing pharmaceutical facilities for 20 years, so I understand the topics.”

Three experts joined him:

  • Dr. Rakhi B. Shah, Acting Branch Chief, Office of Process and Facilities, FDA Branch Chief (Acting), FDA/CDER/OPQ
  • Jennifer Mitchell, Senior Manager, Validation Engineering, Biogen
  • Jenn Walsh, Director of Robustness & Validation, Bristol-Myers Squibb

“We’re here to have a great conversation,” said Mitchell.

McGlade led the group through a preliminary discussion around questions like: “What is the meaning of life cycle?” and “What is the goal of quality management?” Participants then broke into groups for 45 minutes of lively conversation.

Each table considered a set of questions on data integrity, quality systems, process equipment validation and verification, or quality control.

Afterwards, participants reconvened to share the results of their discussions. These included steps to avoid data breaches, minimum elements for data accuracy and consistency, and understanding business processes information to identify elements most critical to product quality.

The groups also discussed safety measures that help ensure data integrity. Responses included security access, training, organizational culture, and management support for people who identify mistakes.

“Firms almost always want to know who was responsible,” one participant said, “because they’re already biased about what the root cause is. Are they trying to fix the system or find the easiest culprit? Culture has to be changed from supervisors on up.”

“We’ve heard ‘culture’ over and over,” said McGlade. “How many companies support self-reporting?” A show of hands indicated that most did.

“The whole point of this workshop was life cycle management, trying to tie in everyone’s experience,” said McGlade. “We found lots of overlap.”


Get a full conference recap by visiting the official 2017 ISPE/FDA/PQRI Quality Manufacturing Conference website.  Interested in attending the 2018 Quality Manufacturing Conference?  Sign up to receive notifications include early registration discounts, Keynote speaker announcements, and more.

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