Registration
SESSION I: Particle Control: Welcome Remarks
Regulatory Updates and Compliance Challenges for Particulate Matter in Parenteral Preparations
Brooke Higgins (Invited)
  • Brooke Higgins (Invited) (Senior Policy Advisor for the Global Compliance Branch 3, CDER at US FDA)

    Brooke Higgins (Invited)

    Senior Policy Advisor for the Global Compliance Branch 3, CDER at US FDA
Best Practices for Visual Inspection Process Validation: A Case Study
Case Study for Overcoming High False Reject Rate and Trending Analysis from AVI. (Defect detection rate & False reject rate)
Won Min Kim
  • Won Min Kim (Assistant Manager, Bio-Process Team at Green Cross)

    Won Min Kim

    Assistant Manager, Bio-Process Team at Green Cross
Panel Discussion and Q&A
Coffee Break at the Exhibition Hall
SESSION II: Points to Consider in Facilities Design: Welcome Remarks
Enhancing Existing RABS Design and Setup: A Case Study on Eliminating Human Ingr
Presentation (TBC)
Panel Discussion and Q&A
Product Demo
Lunch Break at the Exhibition Hall
SESSION III: Annex I Implementation (Part I): Welcome Remarks
Annex 1 Implementation Update
Peter Qiu
  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
Revised Annex 1 Implementation Learnings & Opportunities
Gabriel Gori (Invited)
  • Gabriel Gori (Invited) (Chair, Science Advisory Board at Parenteral Drug Association)

    Gabriel Gori (Invited)

    Chair, Science Advisory Board at Parenteral Drug Association
Panel Discussion and Q&A
Coffee Break at the Exhibition Hall
SESSION IV: Annex 1 Implementation (Part II): RMM/CCS: Welcome Remarks
CCS Implementation and Continuous Improvement through Shopfloor Walkthrough
Annex 1 Implementation, Part 1. Case Study
Annex 1 Implementation, Part 2. Rapid Micro Methods (RMM)
Panel Discussion and Q&A
Registration
SESSION V: QMM Lessons Learned: Welcome Remarks
Lessons Learned from Pre-approval/Pre-license Inspection: Explaining Observations for Better Understanding

Zhong Li, US FDA (Invited)

QMM Implementation Journey
Quality Maturity Model QMM Case Study
Niraj Mehta (Invited)
  • Niraj Mehta (Invited) (Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD)

    Niraj Mehta (Invited)

    Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD
Panel Discussion and Q&A
Coffee Break at the Exhibition Hall
SESSION VI: Digital Transformation: Data Analytics: Welcome Remarks
1/Data integrity • Case study: Data vulnerability assessment (Paper based, Hybrid, and electronic system) 2/Paperless validation software implementation (KNEAT) case study
Data-driven Inspection Readiness and CMO Selection

Austin Caudle, Redica (Invited)

Data Integrity and Governance Case Study

Kir Henrici, The Henrici Group (Invited)

Panel Discussion and Q&A
Product Demo
Lunch Break at the Exhibition Hall
SESSION VII: Combination Products: Welcome Remarks
Medical Device: Case Study

by Stevanato Group

TBD
Panel Discussion and Q&A
Coffee Break at the Exhibition Hall
SESSION VIII: PDA Technical Reports and PtC Updates: Welcome Remarks
Update
Gabriel Gori (Invited)
  • Gabriel Gori (Invited) (Chair, Science Advisory Board at Parenteral Drug Association)

    Gabriel Gori (Invited)

    Chair, Science Advisory Board at Parenteral Drug Association
Update
Emily Cheah
  • Emily Cheah (Senior Managing Director of Charles River Laboratories)

    Emily Cheah

    Senior Managing Director of Charles River Laboratories
Update
Hue Kwon
  • Hue Kwon (Member, RAQAB at Parenteral Drug Association)

    Hue Kwon

    Member, RAQAB at Parenteral Drug Association
Panel Discussion and Q&A
Closing Remarks

The information presented at this conference is accurate as of its launch date. However, the organizers retain the right to modify, update, or amend any details as needed. As we aim to provide the most current information and updates, we encourage you to check regularly for any changes.