Volume 29 previews the first-half PQM seminar in Ansan and reviews updates to distribution guidance and Honeywell’s quality management software.
PQM spring seminar in Ansan
The PQM 2025 First Half Spring Academic Seminar will take place on Friday, June 27, in the second-floor Grand Ballroom at Hotel Square Ansan. The program begins at 2:00 p.m., with registration from 1:00 p.m.
Jusung Park of Hanmi Pharmaceutical will present a contamination control strategy case study. Seunghoon Lee of Waters Korea will examine data integrity through a warning letter case study. Minki Kim and Hyunji Kim, from the Ministry of Food and Drug Safety’s Gyeongin Regional Office, will discuss GMP consultation, compliance measures, and recent major violations.
Hotel information is available online or by telephone on 031-490-2000.
Ireland’s GDP guidance
Ireland’s Health Products Regulatory Authority published version 8 of its Guide to Good Distribution Practice of Medicinal Products for Human Use on April 8, 2025. The guide covers quality management, personnel, premises and equipment, documentation, operations, complaints and recalls, outsourced activities, self-inspection, transportation, and brokers.
For distribution teams, relevant areas include temperature monitoring, transport risk assessment, and records relating to outsourced activities. Read the HPRA guide or the accompanying industry report.
TrackWise and TrackWise Digital Spring ’25
The Spring ’25 update includes document renumbering and changes to numbering conventions for legacy records. AI updates cover the CAPA Evaluator, semantic insight mapping, and a consolidated metrics dashboard.
Platform changes include Family Tree support in Quality Process Accelerators, improved child-record lookups, and translation of workflow statuses and actions. Complaint management updates address the usability and responsiveness of electronic medical device reporting forms.
Training management adds controls for delaying assignments until prerequisite training is complete, along with configurable, printable certificates. The on-premises TrackWise release also includes a technology stack upgrade.
For inquiries, contact [email protected].