Registration
Sterilization Method Per FDA/EAM Perspective
James Agalloco (Invited)
  • James Agalloco (Invited) (President at Agalloco & Associates)

    James Agalloco (Invited)

    President at Agalloco & Associates
SESSION I: Particle Control

Welcome Remarks by the Moderator

Regulatory Updates and Compliance Challenges for Particulate Matter in Parenteral Preparations
Brooke Higgins (Invited)
  • Brooke Higgins (Invited) (Branch Chief, CDER Office of Compliance / Office of Manufacturing Quality at US FDA)

    Brooke Higgins (Invited)

    Branch Chief, CDER Office of Compliance / Office of Manufacturing Quality at US FDA
Q&A Session
Brooke Higgins (Invited)James Agalloco (Invited)
  • Brooke Higgins (Invited) (Branch Chief, CDER Office of Compliance / Office of Manufacturing Quality at US FDA)

    Brooke Higgins (Invited)

    Branch Chief, CDER Office of Compliance / Office of Manufacturing Quality at US FDA
  • James Agalloco (Invited) (President at Agalloco & Associates)

    James Agalloco (Invited)

    President at Agalloco & Associates
Coffee Break at the Exhibition Hall
Best Practices for Visual Inspection Process Validation: A Case Study
Steve Langille

A phase appropriate process validation program for visible defects should begin during process and product development and evolve with changes to the manufacturing process, product and/or container closure system, and the types of visible defects found in clinical and production batches. This presentation will summarize some of the regulatory expectations for visible defect prevention and evaluation during product development. A case study will be presented on the challenges of visible particulate control and inspection during clinical development of a difficult to inspect biological product

  • Steve Langille (Senior Microbiology Consultant at Valsource)

    Steve Langille

    Senior Microbiology Consultant at Valsource
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
Won Min KimSteve Langille
  • Won Min Kim (Assistant Manager, Bio-Process Team at Green Cross)

    Won Min Kim

    Assistant Manager, Bio-Process Team at Green Cross
  • Steve Langille (Senior Microbiology Consultant at Valsource)

    Steve Langille

    Senior Microbiology Consultant at Valsource
Lunch Break at the Exhibition Hall
SESSION II: mproving sterility assurance, PtC in Facilities Design and Aseptic Training

Welcome Remarks by the Moderator

How to Make the Best Use of Open RABSA Case Study on Overcoming Design Limitation with Supplementary Tool and Enhanced Control Strategy
Taehoon KimJaehee Kim

This presentation outlines a journey of enhancing the existing Restricted Access Barrier System (RABS) design and procedures to meet the stringent expectations of the FDA. 

We will discuss the modifications made to the RABS design after a comprehensive risk assessment, focusing on critical areas identified by the FDA for improvement.

This includes installation of mechanical arms, introduction of supplementary tools and modification of existing filling components, those aimed at eliminating human ingress.

Additionally, we will delve into the refinement of RABS setup procedures to assure both product sterility and operation efficiency.

This involves applying multiple sterile packages for the materials which are transferred into the RABS, removing open-door intervention during the filling , and also comprehensive training programs to ensure compliance and consistency.

Through this presentation, attendees will gain insights into the challenges faced in aligning existing RABS with FDA regulatory standards and the strategies employed to achieve approval. We hope our experience serves as a useful case study for those who are navigating similar compliance hurdles in sterile product manufacturing in pharmaceutical industry.

  • Taehoon Kim (Johnson & Johnson)

    Taehoon Kim

    Johnson & Johnson
  • Jaehee Kim (Johnson & Johnson)

    Jaehee Kim

    Johnson & Johnson
Streamlining Aseptic Operator Training: Success Stories of VR Training Implementations
Sebastian Scheler

In the realm of pharmaceutical research and development (R&D) and manufacturing, Virtual Reality (VR) plays an increasingly pivotal role in the training and qualification processes for employees. However, despite its potential, most VR-based training systems remain in the pilot phase and are not yet fully integrated into regular operator training programs. This hesitation largely stems from the inherent complexity of the training requirements. Different training areas within a facility need to be addressed, varying role profiles demand customized training programs, and individuals have unique learning preferences. This presentation delves into strategies to effectively navigate these complexities. It showcases three compelling case studies that illustrate innovative solutions in VR training: 1. The first case study explores Takeda's modular approach to VR training. This method allowed them to successfully achieve GxP validation, ensuring that their VR training met rigorous regulatory standards. 2. The second case study provides insights from Ferring's implementation of a role-based VR training curriculum. This tailored approach delivered individualized training plans to different groups of employees, enhancing the relevance and effectiveness of the training. 3. The final case study highlights how Johnson & Johnson combines VR technology with traditional learning media, such as video-based training. This blended learning approach combines the strengths of both methods to create a comprehensive and versatile training experience. Through these case studies, the presentation aims to demonstrate how VR can be seamlessly integrated into the pharmaceutical training landscape, addressing the diverse and complex needs of modern training programs.

  • Sebastian Scheler (Managing Director of Innerspace GmbH)

    Sebastian Scheler

    Managing Director of Innerspace GmbH
Panel Discussion and Q&A
Taehoon KimJaehee KimSebastian Scheler
  • Taehoon Kim (Johnson & Johnson)

    Taehoon Kim

    Johnson & Johnson
  • Jaehee Kim (Johnson & Johnson)

    Jaehee Kim

    Johnson & Johnson
  • Sebastian Scheler (Managing Director of Innerspace GmbH)

    Sebastian Scheler

    Managing Director of Innerspace GmbH
SESSION III: Annex I Implementation (Part I)

Welcome Remarks by the Moderator

Annex 1 Implementation Update
Peter Qiu

In this presentation, Peter will share industry's approaches when implementing contamination control strategy based on EU Annex 1 requirements. This presentation will also provide regulatory expectations on assessing CCS during CMC review and inspections.

  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
Annex 1 Implementation and Inspection Experience
Ditte Kivsmose Kaldor

Short introduction on how the company is handling new requirements across the value chain with special focus on the revised EU GMP Annex 1: Manufacture of Sterile Medicinal Products which came into force August 2024. During the presentation, the attendees will get insights on examples on implementation and on inspection experience.

  • Ditte Kivsmose Kaldor (Quality Director, PS Aseptic Manufacturing QA of Novo Nordisk)

    Ditte Kivsmose Kaldor

    Quality Director, PS Aseptic Manufacturing QA of Novo Nordisk
Coffee Break at the Exhibition Hall
SESSION IV: Annex 1 Implementation (Part II): RMM/CCS

Welcome Remarks by the Moderator

A Sustainable Future for Endotoxin Analysis Utilizing Innovative Recombinant Cascade Reagent (rCR)
Alan Hoffmeister

Ensuring product quality, patient safety, and profitability is paramount amongst corporations globally. However, Environmental and Social Governance (ESG) strategies are becoming prioritized, focusing on reducing ecological impact through the 3Rs (Replacement, Reduction, and Refinement), ensuring the longevity of supply chains, and supporting greener business operations. The adoption of recombinant cascade reagents (rCR) within pharmaceutical and biopharmaceutical manufacturing organizations as a replacement for the natural horseshoe crab derived Limulus Amebocyte Lysate (LAL) represents a paradigm shift in endotoxin testing. With multiple options and vendors on the market, it can be challenging to recognize which technology is optimal for your endotoxin testing program. In this presentation, we’ll discuss the compatibility of the reagents, current regulatory status, and validation requirements for rCR.

  • AH

    Alan Hoffmeister

    Senior Global Scientific Portfolio Specialist at Charles River Laboratories
Annex 1 Implementation, Part 2. Rapid Micro Methods (RMM)
Panel Discussion and Q&A
Peter QiuDitte Kivsmose KaldorAlan Hoffmeister
  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
  • Ditte Kivsmose Kaldor (Quality Director, PS Aseptic Manufacturing QA of Novo Nordisk)

    Ditte Kivsmose Kaldor

    Quality Director, PS Aseptic Manufacturing QA of Novo Nordisk
  • AH

    Alan Hoffmeister

    Senior Global Scientific Portfolio Specialist at Charles River Laboratories
Registration
Session V: Recent FDA Pre-approval/Pre-license Inspection Learnings

Welcome Remarks by the Moderator

Lessons Learned from Pre-approval/Pre-license Inspection: Explaining Observations for Better Understanding
Microbial Control and Cleaning
Juhong Liu
  • Juhong Liu (President at GlobalSubmissions Consulting, LLC)

    Juhong Liu

    President at GlobalSubmissions Consulting, LLC
Panel Discussion and Q&A
Juhong Liu
  • Juhong Liu (President at GlobalSubmissions Consulting, LLC)

    Juhong Liu

    President at GlobalSubmissions Consulting, LLC
Coffee Break at the Exhibition Hall
Session VI: Improving Data Integrity Controls and Quality Maturity for CGMP Compliance

Welcome Remarks by the Moderator

Data integrity – Case study: Data vulnerability assessment and KNEAT (Paperless validation software) implementation
Haneul JieHannah Lee

This presentation aims to share a case study that serves as a valuable example of the new framework for enhanced data integrity and data governance. The presentation will discuss the results and lessons learned from a comprehensive one-year data vulnerability assessment conducted at a manufacturing site that relies heavily on manual batch records. The assessment took place at a large molecule site located in Incheon Songdo, where the majority of the facilities consist of standalone manufacturing equipment. Due to the complex and intricate hybrid data flows within the GxP systems and procedures, evaluating data vulnerability and implementing technical data control presented significant challenges in terms of feasibility and prioritization. Nonetheless, an action plan was ultimately devised, taking into consideration unique factors, areas for improvement, and the future assessment of additional Quality Control (QC) equipment.

In line with this initiative, KNEAT Digital Validation System was introduced as a proactive measure to eliminate the inherent data vulnerability associated with hybrid documentation in the process of QC Analytical Instrument Qualification. This innovative solution streamlines the entire process through transition onto a robust digital platform, from devising URS and protocols to the execution of test items, creation of deviation reports, and eventually the QA approval of the complete qualification package to be completed online. Our presentation showcases how data integrity and governance can be significantly enhanced by utilizing this system, as it provides a full audit trail of documentations and a comprehensive traceability matrix, ensuring transparency and accountability of the qualification data.

  • Haneul Jie (Johnson & Johnson)

    Haneul Jie

    Johnson & Johnson
  • Hannah Lee (Johnson & Johnson)

    Hannah Lee

    Johnson & Johnson
Data-driven Inspection Readiness and CMO Selection
Michael de la TorreNiraj Mehta

Redica Systems will share proprietary analytics on its inspection and enforcement trends for the Korean market, Asia, and the CMO space in general. We will leverage real examples of how Redica's risk scoring models have helped Merck leverage agency data to be more proactive with their Quality Unit.

  • Michael de la Torre (CEO of Redica Systems)

    Michael de la Torre

    CEO of Redica Systems
  • Niraj Mehta (Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD)

    Niraj Mehta

    Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD
Lunch Break at the Exhibition Hall
Data Integrity and Governance Case Study

Kir Henrici, The Henrici Group (Invited)

QMM Case Study: MSD/ Merck
Niraj Mehta

This session will share real-world case studies that illustrate how assessing an organization's Quality Management Maturity (QMM) across key dimensions can reveal important areas for improvement. Insights will be provided on best practices for conducting effective maturity assessments and developing actionable roadmaps. Attendees will come away with the understanding that closing maturity gaps can lead to proactive risk reduction, more robust continuous improvement culture, and enhanced operational efficiency.

  • Niraj Mehta (Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD)

    Niraj Mehta

    Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD
Panel Discussion and Q&A
Hannah LeeHaneul JieMichael de la TorreNiraj Mehta
  • Hannah Lee (Johnson & Johnson)

    Hannah Lee

    Johnson & Johnson
  • Haneul Jie (Johnson & Johnson)

    Haneul Jie

    Johnson & Johnson
  • Michael de la Torre (CEO of Redica Systems)

    Michael de la Torre

    CEO of Redica Systems
  • Niraj Mehta (Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD)

    Niraj Mehta

    Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD
Coffee Break at the Exhibition Hall
SESSION VII: Combination Products

Welcome Remarks by the Moderator

Risk mitigation in Combination Product Development for Biosimilars: Case Study on Prefilled Syringe Functionality and Autoinjector Performance
Enrico Barichello

Biopharmaceutical and Biosimilar Companies have an increasing interest in developing prefilled syringe and autoinjector combination products for their injectable molecules. In addition to the standard evaluation of drug stability, in the early stage of drug development the thorough assessment of the compatibility between drug product, container-closure system (CCS) and injection device is recommended. Based on an actual case study developed for a Biotech Client, this paper illustrates the testing methods and rationales specifically applied in the assessment of syringe and device functionality, exploring key performances of the injection system as a whole. Advanced syringe coating techniques to prevent unwarranted drug, CCS and device interactions over time, resulting for example in variability of the injection duration, are also disclosed.

  • Enrico Barichello (Product Manager at Stevanato Group)

    Enrico Barichello

    Product Manager at Stevanato Group
Case Study
Panel Discussion and Q&A
Enrico Barichello
  • Enrico Barichello (Product Manager at Stevanato Group)

    Enrico Barichello

    Product Manager at Stevanato Group
SESSION VIII: PDA Technical Reports and PtC Updates

Welcome Remarks by the Moderator

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
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.