
Save the date
Don't miss the chance to reconnect with colleagues, discover new ideas, and be inspired by the groundbreaking work showcased at this year's conference. Let's join us and continue to drive innovation and excellence in the life-sciences industry.
Agenda
This program is accredited for 10.25 CPE Credits.
21 July 2025
Plenary Sessions
-
ISPE Thailand Hackathon Winner Presentation
-
Diversifying in Pharmaceutical Industry
-
Diversified approach to achieve Quality Culture Excellence
Track 1
-
ATMPs: State of the industry and emerging trends
-
Manufacturing Network Management
-
Key success from research to commercial of ATMPs
-
Lean Manufacturing for OSD Production
-
Continuous Improvement of Manufacturing through Automation
-
​Envisioning New Concepts for Pharmaceutical 3D Printing and Solubility Enhancement
Track 2
Track 3
-
Annex 1 requirements from a former regulator view and part of the Annex 1 working group
-
Personal training as gowning and aseptic behavior
-
Environmental Monitoring and Annex 1 requirement
-
APS Introduction
22 July 2025
Track 4
-
Data Integrity Risk Assessment - Identify and Mitigate Data Gaps
-
Practical Strategies for Digital Quality Management
-
​Risk Management Plan (RMP) in the Pharmaceutical Lifecycle
-
Facility Design for ATMPs
-
Considerations for Single – Use Technologies versus Stainless Steel Systems
Track 5
Track 6
-
PIC/s Annex 1, PIC/s Annex 2A and the revision of the EU GMP Part IV for ATMPs, QRM and CC
-
Barrier as RABS and Isolators, First Air, Indirect Product Contact parts, Gloves and Material transfers in Grade A Part 1-2
-
Workout in Groups about Barrier with presentation of the results
-
ISPE Pharma 4.0
-
Holistic Digital Transformation for Brownfield API Factories: Maximizing Impact Through
Strategic Planning -
Strategic Integration in GMP Manufacturing:
Enhancing Efficiency and Quality -
Transforming Manufacturing Efficiency: How to Successfully Implement EBR and MES Systems
Track 7
-
HVAC Cooling Efficiency Evaluation: Excellent, Good, Fair or Need improvement
-
Introduction to ISPE Good Practice Guide:
Heating, Ventilation, & Air Conditioning (2nd Edition) and Training Course (T14)
HVAC & Environmental Control for Life
Science Facilities -
Cleanroom Testing & Monitoring for compliance with PIC/S GMP
Track 8
Track 9
-
The Use of Quality Risk Management to Support Commissioning and Qualification
-
QRM Based Integrated C&Q Series - Implementing a Science and Risk Based Approach to Commissioning & Qualification
​
(VDO Recorded)
Plant Visit
23 July 2025 (add-on, optional)
ISPE Members only | Limited to 25 visitors / plant