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  James Agalloco

  President at Agalloco & Associates

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  James Agalloco

  President at Agalloco & Associates
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  Brooke Higgins (Invited)

  Branch Chief, CDER Office of Compliance / Office of Manufacturing Quality at US FDA
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  Hue Kwon

  Member, RAQAB at Parenteral Drug Association

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

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  Steve Langille

  Senior Microbiology Consultant at Valsource

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  Won Min Kim

  Assistant Manager, Bio-Process Team at Green Cross
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  Steve Langille

  Senior Microbiology Consultant at Valsource
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  Hue Kwon

  Member, RAQAB at Parenteral Drug Association

Welcome Remarks by the Moderator

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  Seung Hwan Oh

  Site Quality Head at Johnson & Johnson

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.

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  Sebastian Scheler

  Managing Director of Innerspace GmbH

Welcome Remarks by the Moderator

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  Javier Camposano

  Vice President of Drug Product Operations at Samsung Biologics

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.

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  Ditte Kivsmose Kaldor

  Quality Director, PS Aseptic Manufacturing QA of Novo Nordisk

Key Take-aways:
- Real-time quality control (QC) testing for critical utility water systems to detect contamination, including biofilm, utilizing rapid endotoxin testing to provide immediate and accurate contamination status, allowing for swift corrective actions.
- Integration of automation and archived standard curves in QC processes, minimizing human error, streamlines investigations, and improves data integrity, ensuring timely and accurate results for decision-making.
- Strategic transition to sustainable, animal-free endotoxin testing methods, providing a reliable and accurate alternative to traditional endotoxin testing, aligning with sustainability goals and regulatory requirements.

Synopsis:
The latest update to Annex 1 mandates that manufacturers of sterile products adopt a quality risk management approach, involving thorough risk assessments to identify and mitigate contamination threats. This requirement encompasses both purified water (PW) and water for injection (WFI), recognizing them as critical utilities when they directly contact the product, materials, or contact surfaces that directly impact product.

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  Alan Hoffmeister

  Senior Global Scientific Portfolio Specialist at Charles River Laboratories

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  Alan Hoffmeister

  Senior Global Scientific Portfolio Specialist at Charles River Laboratories
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  Emily Cheah

  Senior Managing Director of Charles River Laboratories

This presentation aims to provide a comprehensive overview of the elements of Environmental Monitoring Performance Qualification (EMPQ) for new facilities, based on industry led guidance. It will detail key EMPQ elements, such as prerequisites, setting alert levels/action limits, sampling requirements, and acceptance criteria. Additionally, the presentation will showcase case studies to illustrate how these concepts can be applied in practice and to share lessons learned based on EMPQ execution following the harmonized guidance. The objective is to equip attendees with the knowledge to effectively plan and execute EMPQ, ensuring cleanroom environments meet stringent quality standards.

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  Hilary Chan

  Global Sterility Assurance and Microbiology Lead at Takeda

The majority of biologics processing steps provide an environment that can sustain microbial growth. To ensure patient safety, control of microbial contamination is critical in biologics manufacturing process. Microbial contamination control can be achieved from 1) cleaning of purification systems, including resin, membrane, column and skid; 2) cleaning of other surfaces; 3) adquete environmental monitoring program and actions should microbial excursions occur. Lack of validation of these aspects can result in Observations during on-site inspections.

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  Juhong Liu

  President at GlobalSubmissions Consulting, LLC

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.

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  Haneul Jie

  Johnson & Johnson
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  Hannah Lee

  Johnson & Johnson

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.

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  Niraj Mehta

  Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD

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.

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  Enrico Barichello

  Product Manager at Stevanato Group

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  Enrico Barichello

  Product Manager at Stevanato Group
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  Paolo Golfetto

  Director of Business Development, Drug Delivery Systems at Stevanato Group