1.Thank You for Joining Us at Honeywell Life Sciences 2025 Korea!
On August 21, 2025, Connexo participated in the Honeywell Life Sciences World Tour Korea 2025 held at Enfold Hotel, Cheongju, as a featured speaker and key sponsor.
In our session titled “Connexo Service & Support,” we shared real-world experiences in:
- Implementing TrackWise-based Quality Management Systems
- Integrated DMS/TMS operations
- Connexo-Visualizing and analyzing quality data using CoVA
- Applying validation and CSV practices
- Utilizing TrackWise Digital and Help Desk for daily operations
This session offered practical strategies and tools for companies planning digital quality transformation in the life sciences industry.
2. PDA Aseptic Processing of Biopharmaceuticals Conference 2025 – Connexo as Sponsor
Connexo is proud to sponsor the PDA Aseptic Processing of Biopharmaceuticals Conference 2025, which will take place at the Sheraton Grand Incheon Hotel on November 4–5, 2025.
The event brings together global experts to discuss critical advancements in aseptic manufacturing, Annex 1 implementation, contamination control, data integrity, CGT manufacturing, packaging innovation, and more.
๐ฏ Early bird registration is open through September 2025 – secure your discounted rate today!
๐ Event Details
l Event: PDA Aseptic Processing of Biopharmaceuticals Conference 2025
l Date: November 4–5, 2025 (Tuesday–Wednesday)
l Venue: Sheraton Grand Incheon Hotel, Incheon, Korea
l Organizer: Parenteral Drug Association (PDA)
๐ Conference Session Highlights
๐ Day 1 – Tuesday, November 4
|
Session |
Topic |
|
Session 1 |
Annex 1 Implementation – Progress, updates, and practical insights |
|
Session 2 |
Contamination Control Strategies – Risk-based approaches and case sharing |
|
Session 3 |
Emerging Technologies in Aseptic Biomanufacturing – mRNA, ADCs, closed systems |
|
Session 4 |
Audit Reports & Compliance Challenges – Inspection findings and USP <86> transition |
๐ Day 2 – Wednesday, November 5
|
Session |
Topic |
|
Session 5 |
Data Integrity & Digital Compliance – Global audit trends and mitigation strategies |
|
Session 6 |
Supply Chain Resilience & Cold Chain Logistics – GxP-based transport solutions |
|
Session 7 |
Packaging Innovations for Parenterals – Advances in aseptic fill-finish packaging |
|
Session 8 |
Cell & Gene Therapy – Unique aseptic manufacturing challenges and solutions |
๐ View Full Agenda & Register
3. TrackWise Digital Summer ’25 – September Update
The Summer ’25 release of TrackWise Digital, provided by Honeywell, is scheduled to go live in September 2025.
We encourage all clients to review the upgrade guidance from Connexo before the rollout.
4. FDA Alert – GLP-1 Compounded Products Pose Serious Risk
The U.S. FDA has issued a warning about compounded semaglutide products (GLP-1 class) being distributed online with significant quality and safety concerns.
- Issue: Substitution of semaglutide with semaglutide sodium, an unapproved substance
- Risk: Lack of verified safety and efficacy of semaglutide sodium
- Context: Rising demand for GLP-1 drugs like Ozempic and Wegovy for diabetes and weight loss
- FDA Action: Enforcement warning on use of unapproved active ingredients
๐ References
· FDA – FDA’s Concerns with Unapproved GLP-1 Drugs
· FDA – Clarification of Compounding Policies for GLP-1 Supply
· ADA Diabetes Care – Compounded GLP-1 and Dual GIP/GLP-1 Receptor Agonists
· EatingWell – What Are GLP-1 Compounding Formulas and Are They Safe?
5. Cleaning Validation – Digital Transformation in Action
In GMP-regulated manufacturing, Cleaning Validation (CV) is a critical process to prevent cross-contamination and maintain product integrity. Yet many organizations still rely on manual tracking using spreadsheets.
โ Key Challenges in Manual CV:
l Missed retesting schedules and incomplete documentation
l Scattered records of protocols and results
l Limited traceability during inspections
โ Benefits of Going Digital:
l Centralized management of CV plans, results, and historical records
l Automated alerts for retesting and risk-based scheduling
l Instant reports by equipment, product, or process
l Full 21 CFR Part 11 compliance with e-signatures and audit trails
Connexo supports clients with customized workflows and tools for end-to-end digital CV lifecycle management.
6. Global Regulatory Trends – EMA / PIC/S / MFDS
๐ EMA: Updated GDP Guidelines (June 2025)
l Enhanced requirements for temperature monitoring systems
l Detailed guidance for transport risk assessment
l Clear documentation and oversight expectations for brokers
๐ PIC/S: Ongoing Annex 1 Implementation Monitoring
l National authorities conducting inspections with Annex 1 compliance as a key criterion
๐ MFDS (Korea): Post-Marketing Safety Regulation Reform
l Shift from PMS-based to RMP-driven safety monitoring
l Legal framework strengthened for RWD/RWE-based safety evaluation
l New requirements for documentation and risk plans enforcement