1. Event Announcement
PQM 2025 First Half Spring Academic Seminar
Join CONNEXO at the PQM 2025 Spring Seminar to explore practical case studies, data integrity challenges, and regulatory updates from Korea’s leading pharmaceutical quality professionals and authorities.

🗓️ Date: Friday, June 27, 2025, at 2:00 PM (Registration opens at 1:00 PM)
📍 Venue: Hotel Square Ansan (formerly Hotel Square by Savills)
📌 Ballroom: Grand Ballroom, 2nd Floor
☎ Contact: 031-490-2000

Featured Topics and Speakers:

• CCS Case Study
  Jusung Park, Team Leader – Hanmi Pharmaceutical

• Warning Letter Case Study: Data Integrity
  Seunghoon Lee, Deputy General Manager – Waters Korea

• Case Analysis: GMP Consultation & Compliance Measures
  Minki Kim, Officer – MFDS, Gyeongin Regional Office, Drug Inspection Division

• Recent Major GMP Violations
  Hyunji Kim, Officer – MFDS, Gyeongin Regional Office, Product Safety Division

This seminar offers a valuable opportunity to discuss current GMP trends, real-world quality risks, and enforcement priorities.

📩 For event questions or demo requests: [email protected]

2. Regulatory Updates
Ireland’s HPRA Releases Revised GDP Guide

The Health Products Regulatory Authority (HPRA) has released a comprehensive update to its Good Distribution Practice (GDP) guidelines, raising the bar for compliance in several key areas:

Highlighted Updates:

• Temperature Monitoring
  More stringent expectations for calibration, continuous monitoring, and handling excursions

• Transportation Risk Assessment
  Detailed guidance on assessing and managing supply chain risks

• Broker Oversight
  Enhanced documentation requirements and clearer broker accountability

The revised guide also includes updated content across 10 core chapters, ranging from Quality Management and Premises & Equipment to Self-Inspections and Broker Provisions.

🔗 Read the full summary at GMP Compliance

3. TrackWise / TrackWise Digital – Spring ’25 Highlights
The Spring 2025 release delivers practical enhancements to usability, AI-driven analytics, and regulatory workflow support across the TrackWise product family.

🔹 Document Management

• Renumbering support for existing documents

• Resetting of legacy document numbering conventions

🔹 Artificial Intelligence Enhancements

• Improved CAPA Evaluator

• Semantic Insight Mapping for deeper issue analysis

• Unified AI Metrics Dashboard

🔹 Platform Improvements (TrackWise Digital)

• Family Tree support in Quality Process Accelerators (QPA)

• Enhanced child record lookups

• Built-in translation for workflow statuses and actions

🔹 Complaint Management

• Streamlined eMDR forms for greater usability and responsiveness

🔹 Training Management

• Delay training assignments based on prerequisite status

• Print and configure training certificates

🔹 TrackWise On-Premises

• Core tech stack upgrades to ensure compatibility and performance

These upgrades reflect Honeywell’s ongoing commitment to supporting modern quality management needs in regulated environments.

📩 Request a demo or product consultation: [email protected] | www.connexo.io