WEBINAR:
IVD COMPLIANCE:
HOW CAN FREEZE DRYING HELP?
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11th March 2024
IVD Compliance:
How can freeze drying help?
This webinar aims to provide insights into the intersection of freeze-drying, IVDR compliance, the collaborative efforts of Biopharma Group in optimising diagnostic processes. It also explores the preparation process for the application of the IVDR and the challenges facing IVD companies.
Date: March 11th, 2023
Time: 15:00 – 16:00 (UK/GMT)
Platform: Zoom - Free to Attend
Webinar Presenters:
Dr. Johannes Kehle
PhD
Dr. Kehle has a distinguished track record as executive leader in molecular diagnostics and medical devices.
He currently is Global Head of Molecular R&D and PMO at international pharmaceutical company Grifols and responsible for several molecular platform developments. Previously, he was Vice President of Molecular R&D and Managing Director of the European subsidiary for global human diagnostics company Quidel Corporation. He successfully led the development and launch of Quidel's molecular “sample-to-answer” point-of-care (POC) platform Savanna, with an estimated market potential of USD $3.3B.
Prior to joining Quidel Corporation, he conceptualized and established AnDiaTec, a leading-edge Biotech company developing, producing, and distributing innovative medical diagnostic devices in the human and veterinary diagnostic fields. AnDiaTec developed, approved, and distributed 50+ diagnostic products in more than 40 countries worldwide. Dr. Kehle steered AnDiaTec from concept to attaining goals and the subsequent profitable sale to Quidel Corporation.
Simultaneously, Dr. Kehle was selected as Director of the Board for Enfer Diagnostics, a global veterinary diagnostics organization based in Naas, Ireland with operations in key agriculture markets worldwide. At Enfer, he directed the development of molecular assays used for laboratory diagnosis of infectious diseases.
Prior to founding AnDiaTec, Dr. Kehle was Head of the Gene Technology and Molecular Diagnostics Development Departments at one of Germany’s largest human medical laboratories, Labor Prof. Enders and Partner in Stuttgart, Germany, where he was responsible for the development of molecular assays used for laboratory diagnosis of infectious diseases.
Dr. Kehle started his career in basic research at the Max-Planck-Institute for Developmental Biology in Tübingen, Germany, in the department of 1995’s Nobel laureate Prof. Christiane Nüsslein-Volhard. He holds a Bachelor of Science in Biology, a Master of Science in Developmental Genetics and a PhD in Molecular Virology.
Webinar Presenters:
Niloo Ganji
MSc
Niloo joined Biopharma Group as a Research Scientist in 2020 and has a wealth of expertise in molecular biology techniques and freeze-drying as well as extensive experience in managing diverse projects, formulating products, and equipment validation. Niloo’s educational background includes a MSc in Genomic Medicine and a BSc in Molecular and Cellular Biology (Genetics).
The core of her role is developing understanding of client's requirements ahead of project commencement, creating strategies, and executing projects aimed at meeting those needs. It involves sharing our expertise with the customer in areas such as formulation development, freeze-drying cycle development, process improvement and stability assessments. This allows us to help our clients complete their product development efficiently to a high standard, while ensuring they are delivered on time and within budget.
This webinar aims to provide insights into the intersection of freeze-drying, IVDR compliance, and the collaborative efforts of Biopharma Group in optimising diagnostic processes. It also explores the preparation process for the application of the IVDR and the challenges facing IVD companies.
Topics Covered:
- IVDR overview and regulatory framework
- Risk Management
- Quality Management System (QMS)
- Challenges in applying IVDR regulations (performance evaluation)
- Exploring the potential benefits of freeze-drying
- Adapting Formulation and Process for Optimal Results
- Q&A
Detailed description:
Risk Management: The incorporation of freeze-drying into IVDR-compliant practices necessitates a comprehensive approach to risk management. Identifying potential risks associated with the freeze-drying process is crucial to ensure product safety and efficacy. Factors such as variations in drying conditions, potential microbial contamination, and the impact on product stability demand meticulous risk assessment and mitigation strategies.
Performance Evaluation: Evaluating the performance of freeze-dried products under IVDR guidelines is paramount. This includes assessing the accuracy, precision, and reliability of diagnostic results. Rigorous testing protocols must be established to verify the effectiveness of freeze-drying in preserving the diagnostic integrity, ensuring that the end product meets both regulatory and performance expectations.
Quality Management System (QMS): The integration of freeze-drying into IVDR workflows necessitates an adaptive Quality Management System. Establishing robust processes for documentation, validation, and traceability becomes imperative. Ensuring compliance with IVDR requirements while maintaining the efficiency and consistency of the freeze-drying process demands a proactive and agile QMS.
Challenges in applying IVDR regulations (performance evaluation): Navigating the challenges associated with applying IVDR in the context of freeze-drying requires a strategic and interdisciplinary approach. By addressing risk management, adapting formulations and processes, and emphasising performance evaluation within a robust QMS framework, organizations can successfully align their practices with IVDR guidelines while leveraging the advantages of freeze-drying technologies.
Exploring the potential benefits of freeze-drying: Formulation and cycle recipe both have a vital role in this process. The justifications that are required for some classes of product make using the right formulation more important. Using traceable material and analytical techniques are highly important In meeting IVDR regulations. Different types of analysis which can be performed throughout the R&D stage to assess the robustness of the product will be discussed.
Adapting Formulation and Process for Optimal Results: The pivotal role that a successful freeze-drying process can play in enabling organisations to achieve IVDR compliance through the implementation of freeze-drying process also will be discussed. Certain post-process analysis will be performed on all freeze-dried products to make sure the storage conditions and moisture content are within the required range. Having a consistently functional product once the product is released into the market and after the shipment is one of the main criteria is meeting IVDR regulations.
Register today to secure your place!
Where:
This is an online webinar, hosted on the Zoom platform.
