Factorytalk, together with BatchLine, is pleased to participate in the ISPE Indonesia One-Day Seminar: Optimized & Compliant Digital Operations with EBR & eQMS—a practical, execution-focused event supporting pharmaceutical and life-sciences manufacturers on their digitalisation journey.
The seminar features an exclusive regulatory speaker, Dr. Shanti Marlina from Badan POM – the National Agency of Drug and Food Control Indonesia, who will share regulatory perspectives on EBR and eQMS adoption in Indonesia.
This one-day seminar is designed to help organisations move beyond paper-based processes by understanding how to plan, implement, and sustain compliant digital operations in real GMP environments—particularly within the budget, resource, and regulatory constraints commonly faced by Indonesian manufacturers.
Participants will gain regulatory insight, implementation best practices, and real-world lessons learned from active GMP digitalisation projects.
🎯 Why Attend?
This seminar is ideal for Quality, Manufacturing, IT, and Management teams seeking to:
- Understand regulatory expectations for EBR and eQMS adoption
- Learn how to start digitalisation pragmatically, even with limited budgets
- Avoid common implementation and validation pitfalls
- See how EBR and eQMS fit into real GMP operations
- Learn from practical case studies, not theoretical frameworks
Key Highlights
- Regulatory perspective on how EBR & eQMS support GMP compliance, presented by the Indonesian Food and Drug Authority
- Implementation-focused sessions, covering:
- Practical EBR & eQMS implementation roadmaps
- URS development aligned with GAMP principles and business needs
- Pilot vs. big-bang implementation strategies
- Vendor evaluation and selection criteria
- Panel discussion with regulators and industry experts on:
- Where to start with EBR & eQMS
- Managing budget and resource constraints
- Typical challenges—and how to avoid them
- Live system demonstrations, showing:
- How EBR supports controlled batch execution, audit trails, and review by exception
- How eQMS enables effective deviation, CAPA, and change control management
- Case study sessions, including:
- From Vision to Reality: EBR Implementation in a Regulated Environment with Unison
- Quantifying the Value: ROI from an enterprise eQMS implementation with Unilab
Speakers
- Shanti Marlina – Badan POM – National Agency of Drug and Food Control Indonesia
- Preecha Khawsa-ard – BatchLine
- Vissarut Saksureemongkol – Factorytalk
Together, they will share hands-on experience from real GMP digitalisation projects, focusing on execution, integration, and compliance, not just system features.
Visit the Booth
During the afternoon break, visit the Factorytalk booth to:
- Discuss your specific quality and manufacturing challenges
- Explore how EBR and eQMS integrate with broader GMP systems
- Learn how to start small, scale confidently, and remain inspection-ready
