C5A: Computerised Systems, Current and Future Considerations
Tracks
Goldfields Theatre Breakout 1
| Wednesday, November 20, 2024 |
| 9:00 AM - 9:45 AM |
Details
With the EMA developing a concept paper on revision of Annex 11 and the increasing complexity of computerised systems and their control, introduction and management of computerised systems in GMP environments requires greater oversight and understanding to ensure GMP principles are effectively employed.
This session aims to provide some understanding of the principles raised in the concept paper and to explore some of the more common issues observed during inspections. With the use of Artificial Intelligence (AI) and other smart technologies evolving, awareness of some of these manufacturing and control tools being seen at inspection or coming into sight will be explored. The session will also highlight the critical role of computer systems in advancing the development, manufacturing and regulation of medicines, blood and blood components, HPCs, Biologicals (ATMPs) and associated testing laboratories.
Speaker: Neale Baldwin, Senior GMP Inspector and Team Leader, Inspections Section
Neale has been employed in the pharmaceutical industry for more than 30 years in various biological manufacturing and quality roles as well as leading product/process/facility development project teams. He has also been involved with industry in a consulting capacity as well as regulatory positions. He holds a science degree in Biotechnology as well as other further business qualifications.
He joined the TGA in 2015 as a Senior GMP Inspector in the Manufacturing Quality Branch and is currently a team leader and continues to perform GMP inspections of sterile and non-sterile pharmaceutical manufacturers.
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.
This session aims to provide some understanding of the principles raised in the concept paper and to explore some of the more common issues observed during inspections. With the use of Artificial Intelligence (AI) and other smart technologies evolving, awareness of some of these manufacturing and control tools being seen at inspection or coming into sight will be explored. The session will also highlight the critical role of computer systems in advancing the development, manufacturing and regulation of medicines, blood and blood components, HPCs, Biologicals (ATMPs) and associated testing laboratories.
Speaker: Neale Baldwin, Senior GMP Inspector and Team Leader, Inspections Section
Neale has been employed in the pharmaceutical industry for more than 30 years in various biological manufacturing and quality roles as well as leading product/process/facility development project teams. He has also been involved with industry in a consulting capacity as well as regulatory positions. He holds a science degree in Biotechnology as well as other further business qualifications.
He joined the TGA in 2015 as a Senior GMP Inspector in the Manufacturing Quality Branch and is currently a team leader and continues to perform GMP inspections of sterile and non-sterile pharmaceutical manufacturers.
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.
