C3C: Laboratory Testing for Biologicals
Tracks
Courtyard Room Seminar
| Tuesday, November 19, 2024 |
| 2:05 PM - 3:00 PM |
Details
Testing for blood, HPC and biologicals is regarded as high risk, particularly if they are for donor screening. This seminar will help delegates to navigate some of the nuances and outline TGA expectations of what constitute a validation vs verification, adequate number of specimens to challenge LoD for qualitative assays and the importance of independent controls to track assay performance. There will also be a mock validation protocol to work through to facilitate discussion on the strengths and gaps of the proposed validation study.
Speaker: Samuel Ling, GMP Inspector, Inspections Section
Samuel Ling is an inspector in the blood, cell, tissue and gene therapy team. He has been with the Inspection Section for 3 years. Prior to that he has more than 13 years of experience in the TGA laboratories. His expertise includes international collaborative Proficiency Studies to establish WHO international reference standards and the development of strategies for in-house qualification and testing methods.
Samuel has also received training in glycomics at the Institute of Glycomics, Griffith University and has led several projects in collaboration with the CDC and WHO essential regulatory laboratories. Most notably, the development of stable isotope mass spectrometry for quantitation of flu primary liquid standard.
Speaker: Alyce Maksoud, Senior GMP Inspector & Team Leader, Inspections Section
Alyce Maksoud professional journey began in Haematology and blood bank, microbiology and immunology where Alyce developed a strong foundation in the complexities of blood product management. Alyce then transitioned into molecular, cord blood banking and cellular therapy honing her skills in cutting-edge techniques at the time that ensured safe and effective use of stem cells in therapeutic applications. Her work in cell therapy encompassed both production and quality, allowing her to understand the intricate balance between innovation and regulatory standards. As a GMP inspector, Alyce leveraged her extensive knowledge to uphold the highest standards of quality and safety in the industry. Her leadership role involves guiding a talented team in navigating the regulatory landscape while fostering a culture of excellence and continuous improvement. Alyce is passionate about the intersection of science and patient care, and remains committed to ensuring that the products they oversee are both safe and effective. In her spare time, Alyce enjoys spending time with family, reading, walking, dancing and listening to music which helps her maintain a balanced perspective in her professional life.
Speaker: Samuel Ling, GMP Inspector, Inspections Section
Samuel Ling is an inspector in the blood, cell, tissue and gene therapy team. He has been with the Inspection Section for 3 years. Prior to that he has more than 13 years of experience in the TGA laboratories. His expertise includes international collaborative Proficiency Studies to establish WHO international reference standards and the development of strategies for in-house qualification and testing methods.
Samuel has also received training in glycomics at the Institute of Glycomics, Griffith University and has led several projects in collaboration with the CDC and WHO essential regulatory laboratories. Most notably, the development of stable isotope mass spectrometry for quantitation of flu primary liquid standard.
Speaker: Alyce Maksoud, Senior GMP Inspector & Team Leader, Inspections Section
Alyce Maksoud professional journey began in Haematology and blood bank, microbiology and immunology where Alyce developed a strong foundation in the complexities of blood product management. Alyce then transitioned into molecular, cord blood banking and cellular therapy honing her skills in cutting-edge techniques at the time that ensured safe and effective use of stem cells in therapeutic applications. Her work in cell therapy encompassed both production and quality, allowing her to understand the intricate balance between innovation and regulatory standards. As a GMP inspector, Alyce leveraged her extensive knowledge to uphold the highest standards of quality and safety in the industry. Her leadership role involves guiding a talented team in navigating the regulatory landscape while fostering a culture of excellence and continuous improvement. Alyce is passionate about the intersection of science and patient care, and remains committed to ensuring that the products they oversee are both safe and effective. In her spare time, Alyce enjoys spending time with family, reading, walking, dancing and listening to music which helps her maintain a balanced perspective in her professional life.
