BatchLine, together with Factorytalk, is proud to participate in the ISPE Indonesia One-Day Seminar on Optimized & Compliant Digital Operations with EBR & eQMS —a focused, practical event designed to help pharmaceutical and life-sciences manufacturers move from paper-based processes to compliant, scalable digital operations.
Special regulatory speaker: Dr. Shanti Marlina, Badan POM – National Agency of Drug and Food Control Indonesia, will share regulatory perspectives on EBR and eQMS adoption, including current expectations, key compliance considerations, and how digital systems can effectively support GMP inspections and regulatory readiness in Indonesia.
Join us for a full day of regulatory insight, real-world implementation guidance, live system demonstrations, and a practical case study, all tailored to the realities of Indonesian manufacturers.
🎯 Why Attend?
This seminar is ideal for Quality, Manufacturing, IT, and Management teams looking to:
- Understand regulatory expectations for EBR and eQMS
- Learn how to start digitalisation with limited budgets and resources
- Avoid common implementation pitfalls
- See EBR and eQMS live in action
- Gain practical insights from a real GMP case study
Key Highlights
- Regulatory perspective on how EBR & eQMS support GMP compliance, presented by the Indonesian Food and Drug Authority
- Implementation-focused sessions covering:
- EBR & eQMS roadmaps
- URS creation (GAMP-aligned, business-focused)
- Pilot vs big-bang approaches
- Vendor selection criteria
- Panel discussion with regulators and industry experts:
- Where to start with EBR & eQMS
- Managing constraints in budget and resources
- Typical challenges—and how to avoid them
- Live demos:
- EBR in Action: digital batch execution, review by exception, audit trails
- eQMS in Action: deviations, CAPA, change control, and inspection readiness
- Case Study Session
- From Vision to Reality: EBR Implementation in a Regulated Environment with Unison
- Quantifying the Value: ROI with Unilab
Key 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, not just system features.
Visit the Booth
During the afternoon break, visit the BatchLine & Factorytalk booth to:
- Explore EBR & eQMS demos in more detail
- Discuss your specific manufacturing and quality challenges
- Learn how to start small, scale fast, and stay compliant
