Wednesday 20 November 2024
9:00am - 10:30am
Goldfields Theatre

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.

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.

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. 

Wednesday 20 November 2024
9:00am - 10:30am
Eureka Room 2&3

Deficiencies happen during an inspection and there are always lessons that can be learned from these. Understanding deficiencies raised at other manufacturing sites is valuable information that may better prepare you for your next TGA inspection. 
This session will breakdown the most common inspection deficiencies identified during the past 12 months at both Australian and overseas manufacturers. It will provide a GMP inspector’s insights into the categories of deficiencies, the specific clauses repeatedly cited as well as examples of how these get identified during inspection. 

Jeff Wan
GMP Inspector, Inspection Section

Jeffery Wan is a GMP Inspector with the Manufacturing Quality Branch. Jeff has a wealth of inspection experience both at the TGA and as an auditor in the Asia Pacific Region in industry. Before joining the TGA he has spent 15 years in the pharmaceutical industry in a number of high level quality and production roles in both sterile manufacturing and FMCG (Fast Moving Consumer Goods) in consumer healthcare. He has a particular interest in BFS technology and has extensive expertise in project management systems and strategies.

Wednesday 20 November 2024
9:00am - 9:45am
Courtyard Room

The world is imperfect, including during the manufacture of therapeutic goods. Things do go wrong from time-to-time and when this happens, products may have to be recalled from the Australian market or other actions need to be taken to ensure consumer safety. Would you know what to do if you needed to recall your product? Or have you done recalls in the past and would like a refresher on the processes? In this session, we will provide an overview of Australia’s recall processes. We will also focus on sponsors’ roles and responsibilities which aim to ensure their recall actions are conducted effectively. 

Sharon Bennett
Assistant Director, Recalls Section

Sharon Bennett has worked for the TGA for approx. 16 years. She recently moved to the position of Deputy Australian Recall Coordinator (Assistant Director) in the Recalls Section of the Manufacturing Quality Branch, after gaining extensive regulatory experience in Medical Device post-market areas. 
Sharon has 20 years’ experience in nursing, incorporating areas such as chemotherapy, rehabilitation, surgical, aged care and dialysis. Sharon has a Bachelor of Nursing and Nephrology Nursing Certificate and a Cert IV in Government Investigations. 

Brigida Botticelli
Recall Coordinator, Recalls Section

Brigida Botticelli is an Italian pharmacist with 10-year experience in the pharmacy sector, who joined the Recalls section of the MQB in August 2023.
Her expertise lies in medication counseling, prescription verification and therapeutic recommendations.
In her current role as a Recall Coordinator, Brigida oversees recall and non-recall actions of Therapeutic Goods in Australia prioritising public safety and regulatory compliance as well as ensuring timely and effective recall processes.

Wednesday 20 November 2024
9:45am - 10:30am
Courtyard Room

Class II biologicals play a vital role in treating various diseases and conditions by aiding the body’s repair and reconstruction processes.
The Australian Code of Good Manufacturing Practice (GMP) for Blood and Blood Components, Human Tissues, and Human Cellular Therapy Products establishes requirements to ensure that therapeutic products adhere to safety standards and meet specifications.
This presentation will highlight key areas GMP non-compliance observed during recent TGA inspections with a particular focus on a lack of validation/qualification of critical processes, materials, utilities, and equipment. All of which could significantly affect the quality and safety of biological products.

Nadia Saleh
GMP Inspector, Inspections Section

Nadia Saleh has been a GMP Inspector with the Blood Cell Tissue and Gene Therapy Team in the Manufacturing Quality Branch since 2019.She has worked in different areas within the regulatory environment of the TGA and developed extensive experience in the regulation of Medical Devices, Biological Medicines, Blood and Blood Components, Biologicals and Haematopoietic Progenitor Cells, including quality management, quality control and quality assurance in testing of finished biological products and medical devices. Nadia had also worked in NATA accredited testing laboratories including a hospital pathology and the TGA laboratories where she developed experience in analytical testing method techniques applicable to cellular and tissue testing, such as cytogenetic testing, and immune-histochemical staining techniques to identify specific subset of cells.

Wednesday 20 November 2024
11:00am - 12:30pm
Goldfields Theatre

Annex 16 is a new Annex as part of the PIC/S guide to GMP version 16 called “Certification by the Authorised Person and Batch Release” which was adopted in Australia on 2 September 2024. 
This session will provide an overview of the new Annex delving into the differences between a Qualified Person and Authorised Person and what requirements and expectations exist when performing the confirmation and/or certification functions. Examples and case studies from GMP inspections will be discussed to illustrate the principles from Annex 16 and how departure from these can lead to deficiencies being raised.

Jenny Hantzinikolas
Director, Inspections Section

Jenny Hantzinikolas is the Director of the Inspections Section in the Manufacturing Quality Branch in TGA. She has a degree in Biochemistry and Microbiology. She leads a team of Inspectors who inspect medicines and blood and biological products manufacturers within Australia and overseas. She has been with the TGA for 20 years and was in industry for 17 years. Her experience in industry was in mostly bacterial and viral vaccines and also some experience in oral and topical non sterile medicines.

Gaye Camm
Senior GMP Inspector, Inspections Section

Gaye is a Senior GMP Inspector within the Manufacturing Quality Branch. They have an Honours Chemistry degree and 30+ years working within TGA as both an analytical chemist and GMP Inspector. Gaye is a technical specialist for GMP related to manufacture of listed and complementary medicines, medicinal cannabis, sunscreens and medical gases, and GMP related to QC testing and management of laboratory electronic data capture systems. Gaye currently co-chairs the TGA-Industry Working Group on GMP for Complementary and Listed Medicines.

Wednesday 20 November 2024
11:00am - 12:30pm
Eureka Room 2&3

Medicinal Cannabis manufacture is increasing in Australia and around the world. GMP plays an important role in ensuring product quality evidenced by the inclusion of GMP requirements in the latest update to TGO93.  As new players enter the market, there is a need to continue education and awareness on the importance of GMP for these products.  This session will focus on the key considerations of GMP for medicinal cannabis products as well as common deficiencies that inspectors are observing during inspections of both Australian and overseas manufacturers. 

Maurice Makdessi
Senior GMP Inspector & Team Leader, Inspections Section

Maurice joined the TGA in 2009, he is currently a team leader in the Inspections section. He has science, engineering and management qualifications to masters level and has over 20 years’ experience in the Pharmaceutical industry and held management posts in quality assurance, quality control, production, and R&D at multinational companies in Australia and Overseas. He contributed to research work in teams developing synthetic active pharmaceuticals and finished dose formulations. He also worked earlier on, in forensic toxicology in research, developing analytical methods for quantitation of drug of abuse residue and trace elements in blood and tissue samples.

Wednesday 20 November 2024
11:00am - 11:30am
Courtyard Room

This seminar is for manufacturers and sponsors of herbal therapeutic goods, including medicinal cannabis and will provide information on where GMP principles apply in the manufacture of herbal ingredients. At the end of this session manufacturers of herbal products including medicinal cannabis, should be clear on what activities require the application of GMP principles, and understand under what circumstances a GMP licence may not be required.

Dr Katherine Clark
Director, GMP Operations and Strategy Section, Manufacturing Quality Branch

Katherine has a PhD in cell biology and worked for over 10 years in medical research before joining the TGA in 2002. Katherine has worked in various roles in the regulation of medicines and biological products including as an evaluator of biotechnology products and as a GMP inspector team leader for biological and cell therapy manufacturers. Katherine also has experience as a Good Clinical Practice (GCP) inspector and led the GCP inspection pilot program in Australia. 
In her current role as Director of GMP Operations and Strategy she has responsibility for the business operations of MQB including data reporting systems, the Quality Management System and cost recovery arrangements. The section is also responsible for GMP regulatory reforms including the introduction of quality standards for psilocybine and MDMA and the GMP requirements for medicinal cannabis. In addition, she is responsible for MQB’s GMP signal investigation processes and compliance and enforcement activities.

Nicole Bottle
GMP Operations and Strategy Section

Nicole is an Assistant Director in the GMP Operations and Strategy Section of Manufacturing Quality Branch. Nicole joined the TGA in October 2023 to manage regulatory reform work within the branch, and has focused on reforms to the regulation of medicinal cannabis, MDMA and psilocybine. Prior to joining the TGA, Nicole was at the Department of Agriculture, Fisheries and Forestry working on a range of projects to implement regulatory controls to manage biosecurity risks. 

Wednesday 20 November 2024
11:30am - 12:00pm
Courtyard Room

Submitting effective GMP Clearances applications can be challenging with many variables at play. It can be easy to make mistakes which result in your application being identified as incomplete. Over 10% of submitted applications end up in this situation. This session will explain how to avoid this as well as other common pitfalls with the application process.

Samuel Borg
Assistant Director, GMP Clearance Section

Samuel is an Assistant Director in the GMP Clearance section of the Manufacturing Quality Branch (MQB) and joined the TGA in July 2019.
Prior to joining the TGA, he has experience working in manufacturing facilities in both pharmaceutical aseptic compounding of oncology products and laboratory management in the FMCG industry. Samuel has a Bachelor of Science (Microbiology) and a Graduate Diploma in Environmental Health Practice.

Wednesday 20 November 2024
12:00pm - 12:30pm
Courtyard Room

This seminar provides an overview of the process for adoption of updated versions of the PIC/S Guide to GMP. It highlights the main steps for guidance development, opportunities for consultation with industry, evaluation of changes and adoption. The presentation will also look at future revisions of the PIC/S Guide that are anticipated in the next revisions.

Matt Davis
Senior GMP Inspector & Team Leader, Inspections Section

Matt Davis is a Senior Inspector – Team Leader in the GMP inspections section of Manufacturing Quality Branch. Matt has been with TGA since 2009. Before joining the TGA, Matt held positions in the pharmaceutical industry sector in quality and technical roles, and has spent time in the UK as a GMDP Inspector for the MHRA. Matt was the Co-Chair for the PIC/S Working Group on Data Management and Integrity, and is the TGA representative for the PIC/S EMA revision of Annex 1.

Wednesday 20 November 2024
1:30pm - 3:00pm
Goldfields Theatre

International collaboration and alignment on GMP is fundamental to what we do. With over 90% of medicines supplied to Australia coming from overseas, we rely on this to inform and expedite our sovereign decisions on manufacturers around the world. Similarly, reliance on our own GMP inspections contribute to global regulatory efficiency.
This session will provide an overview of GMP international collaboration activities currently underway in forums such as PIC/S, ICMRA and Access. The session will also explore common misconceptions around our international agreements and arrangements and how these inform the level of inspection reliance or recognition for GMP Clearance. 

Stephen Farrell
Director, GMP Clearance section

Stephen is the Director of the GMP Clearance section of the Manufacturing Quality Branch (MQB) and joined the TGA in January 2016.
The GMP Clearance section is responsible for the GMP evaluation of overseas manufacturing sites as part of a marketing authorisation application. With over 90% of medicines supplied to Australia coming from overseas, the section plays a crucial role in MQB’s goal of assisting in the timely supply of therapeutic goods ensuring they are of appropriate quality for their entire lifecycle. The section also has responsibility for the TGA’s inspection reliance framework which involves the ongoing assessment of other regulatory authorities’ GMP programs for equivalence.
Prior to joining the TGA, Stephen had over 10 years of experience in manufacturing facilities in both Europe and Australia across several categories of Therapeutic Goods including medical devices, biological drug substances, terminally sterilised and aseptic fill/finish operations and radiopharmaceuticals.

Wednesday 20 November 2024
1:30pm - 3:00pm
Eureka Room 2&3

Advanced Therapy Medicinal Products (ATMPs) are complex medicines based on genes, tissues, or cells. They present opportunities for innovative treatments but also pose unique challenges to the current regulatory environment. 
This session will explore the rapidly evolving landscape of ATMPs, highlighting the diversity of products approved for use and the complexity of maintaining compliance management over the product life cycle. The session will also cover products in development as well as the potential emerging regulatory approaches that will be required in the future.

Amanda Louise
GMP Inspector, Inspections Section

Amanda Louise BSc, MClinTRes is a GMP Inspector in the Blood, Tissue, Cell, and Gene Therapy team at the TGA, with over 14 years of advanced biological manufacturing expertise. Her experience includes global technical roles overseeing CAR-T cell product production across EU, US, and APAC regions for clinical and commercial supply. At the GMP Forum 2024, Amanda will discuss regulatory and technical challenges in advanced therapies, drawing on her insights from global tech transfers and her role as a TGA Inspector. She is passionate about ensuring Australians have access to innovative medicines and the impact of digitalisation on manufacturing.

Dr Fran Harding
GMP inspector, Inspections Section

Dr. Fran Harding is a Technical Specialist in human blood, tissues, cell and gene therapies. She has over twenty years’ experience in bioprocess development and manufacturing in Australia and the USA. Her work has explored scale up, tech transfer and production of cell therapies and the development of biomaterials to mimic complex biological microenvironments. In her current role, she acts as an advisor on ATMP and as an inspector of blood and biologics manufacturers. 

Tuesday 19 November 2024
1:30pm - 2:00pm
Courtyard Room

TGA staff often identify several deficiencies or areas requiring clarification during the evaluation of GMP Clearances. Sending Requests For Information (RFI) or Proposal to Not-Issue (PNI) can add significant time onto your applications.
In this seminar, learn about common issues encountered in both the Mutual Recognition Agreement (MRA) and Compliance Verification (CV) pathways to reduce the likelihood of receiving an RFI/PNI in your next application.

Peter Kroek
GMP Evaluator, GMP Clearance Section

Peter made the move to Canberra and joined the TGA as an evaluator in the GMP Clearance section in mid-2023, following 5 years in production and quality assurance roles at an aseptic compounding facility. Peter's experience also includes radiopharmaceuticals and compounding at sites in Australia and the United Kingdom, and time as a minerals processing engineer at mining operations around the country.

Marguerite Walcott-Taylor
GMP Evaluator, GMP Clearance Section

Wednesday 20 November 2024
2:00pm - 2:30pm
Courtyard Room

Terri Dreyer
Assistant Secretary, HPRG Digital Branch

Terri Dreyer leads Health Products Regulation Group’s Digital Branch in the Department of Health and Aged Care. Terri joined the Department in 2021, to lead delivery of the new headtohealth.gov.au gateway and joined the Therapeutic Goods Administration (TGA) digital program in 2023. Prior to joining the Department of Health and Aged Care, Terri has worked in Commonwealth and state government departments in digital, health, economic, immigration and international portfolios.  This includes roles at the Digital Transformation Agency, the Department of the Prime Minister and Cabinet and the Department of Finance. Terri is an advocate for agile and user-centred delivery methods, to deliver great digital products and outcomes. She holds a Master of Public Policy, Bachelor of Commerce, Bachelor of Arts and Post Graduate Diploma in the Arts (Public Policy).

Wednesday 20 November 2024
2:30pm - 3:00pm
Courtyard Room

Manufacture of medicinal cannabis must occur at sites that comply with one of the GMP standards in subsection 13(2) of TGO 93, and the Australian sponsor of the medicinal cannabis product must hold evidence of GMP compliance in accordance with subsection 13(3) of TGO 93.
How do you know if the GMP evidence you have complies with TGO 93 requirements?
This seminar will provide an overview of GMP evidence requirements and includes hands on activities to help participants identify whether GMP evidence complies or does not comply with TGO 93. 

Nicole Bottle
Assistant Director, GMP operations and Strategy Section

Nicole is an Assistant Director in the GMP Operations and Strategy Section of Manufacturing Quality Branch. Nicole joined the TGA in October 2023 to manage regulatory reform work within the branch, and has focused on reforms to the regulation of medicinal cannabis, MDMA and psilocybine. Prior to joining the TGA, Nicole was at the Department of Agriculture, Fisheries and Forestry working on a range of projects to implement regulatory controls to manage biosecurity risks. 

Gaye Camm
Senior GMP Inspector, Inspections Section

Gaye is a Senior GMP Inspector within the Manufacturing Quality Branch. They have an Honours Chemistry degree and 30+ years working within TGA as both an analytical chemist and GMP Inspector. Gaye is a technical specialist for GMP related to manufacture of listed and complementary medicines, medicinal cannabis, sunscreens and medical gases, and GMP related to QC testing and management of laboratory electronic data capture systems. Gaye currently co-chairs the TGA-Industry Working Group on GMP for Complementary and Listed Medicines.

The topics and session times in the program are tentative and may be subject to change.