1. Event Announcement

PQM 2025 First Half Spring Academic Seminar

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

🎤 Topics & 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

Join us to explore real-world quality challenges and up-to-date regulatory insights.

2. Regulatory Updates

📍 Ireland’s HPRA Releases New GDP Guide Update

The Health Products Regulatory Authority (HPRA) of Ireland has published an updated version of its Good Distribution Practice (GDP) guide, introducing heightened expectations and clarifications across core operational areas.

The revised guide strengthens compliance requirements in the following areas:

Temperature monitoring systems – Enhanced expectations for equipment calibration, continuous monitoring, and excursion management
Transportation risk assessment – Detailed guidance for evaluating supply chain vulnerabilities during transit

Broker oversight and documentation – Clearer requirements for ensuring broker compliance with GDP and maintaining robust records

The guide also provides expanded and updated instructions across the following chapters:

Chapter 1 – Quality Management
Chapter 2 – Personnel
Chapter 3 – Premises and Equipment
Chapter 4 – Documentation
Chapter 5 – Operations
Chapter 6 – Complaints, Returns, Suspected Falsified Medicinal Products, and Recalls
Chapter 7 – Outsourced Activities
Chapter 8 – Self-Inspections
Chapter 9 – Transportation
Chapter 10 - Specific Provisions for Brokers

🔗 Read the full article at GMP Compliance

3. TrackWise/ TrackWise Digital – Spring ’25 Highlights

The Spring 2025 release delivers meaningful upgrades across modules:

🔹 Document Management
• Renumber existing document records
• Reset numbering conventions for legacy documents

🔹 Artificial Intelligence
• CAPA Evaluator enhancement
• Semantic insight mapping
• Consolidated AI metrics dashboard

🔹 TrackWise Digital Platform
• Family Tree support in QPAs
• Improved child record lookups
• Built-in translation for workflow status and actions

🔹 Complaint Management
• Improved usability and responsiveness of eMDR forms

🔹 Training Management
• Delay training assignments based on prerequisite training status
• Configure and print training certificates

🔹 TW on Prem
• Tech Stack Upgrade

📩 Inquiries & Demo Requests:

[email protected] / www.connexo.io