Presenter: Dr Stefan Wagener, DG (Director General, retired) for the GOC (Government of Canada) 

                   Quality Management System for Biorisk Management: ISO 35001:2019

                   Monday 30 or Tuesday 31 October : 1 Day workshop 

Biorisk Management is a comprehensive approach to assess, control, mitigate, and ultimately manage risks associated with biological materials. Historically and from a laboratory perspective, this has been done primarily under the umbrella of biosafety and biosecurity programs, practices and principles. However, this more or less reactive approach can no longer be considered sufficient in today’s environment. Consequently, a much more comprehensive and proactive management system approach is required to deliver on the expectations for safe, secure, and ethical research.

This practical and hands-on one-day workshop will introduce the aspects and components of a quality management system based on ISO 35001:2019 as it relates to biorisk management. By utilizing specific quality management tools, approaches and concepts, laboratories will advance their overall compliance and stakeholder satisfaction and move towards a proactive, continuously improving biorisk management system. This will allow for addressing future needs and expectations for safe, secure, and ethical research and development involving biological agents.

Participants will discuss the concept of a quality management system and how it relates to ISO 35001:2019. Concepts like QMS, quality key principles, PDCA, logic model, and risk management will be addressed and applied within practical hands-on exercises during the workshop. By understanding the fundamental principles behind ISO 9000/9001 and 45001, participants will better understand the structure and components of ISO 35001:2019 and its application and implementation within the laboratory setting.

Objectives:

• Identify and describe the relationship between ISO:9001/45001 and ISO:35001
• Restate the principles of a quality management system and explain how it applies to biorisk management
• Name and apply the key components of risk management.
• Describe the advantages and challenges of a biorisk management system!

Suggested Background: Risk assessment, basic biosafety, and biosecurity
Target Audience: Safety professionals, biosafety professionals, laboratory managers, quality managers, regulatory professionals, laboratory directors and executives.

Presenter: Dr Anthony Young,  Senior Lecturer Crop Protection (University of Queensland) 

                   Plant Biosecurity

                   Monday 30  October : 1/2 Day workshop 

Dr Anthony Young is a Senior Lecturer in Crop Protection at the Gatton campus of The University of Queensland (UQ), where he teaches Biosecurity, Plant and Environmental Health and Plant Protection courses. He has diverse research interests that are linked by molecular biology. These include understanding of the role of ground pearls (Hemiptera: Margarodidae) in pasture dieback, diagnosis and management of ratoon stunting disease (RSD) of sugarcane, development of a metabarcoding soil health toolkit, and transcriptomic analysis of the interaction between a bacterial pathogen and its plant host. After completing his PhD on RSD at Macquarie University, Dr Young was employed for 6 years as the Queensland Government Bacteriologist, where he was involved in diagnosing and managing plant diseases, responding to incursions, and providing expert advice on Import Risk Analyses. He then spent four years as an Extension Officer in the NSW Sugar Industry, where implementation of his crop management plans led to record yields. In 2015 Dr Young moved into academia, first at the University of Southern Queensland as a Field Crop Pathologist, and since 2018 at UQ. Dr Young has published on a broad array of subjects, ranging from rubber to pineapples, pathogen genomes to velvet worms, and is fascinated by the biological interactions that are the foundation for the living environment. He is passionate about translating knowledge to the next generation of future decision-makers and helping to secure sustainable food and fibre production systems.

Unknown to most, the year 2020 was the UN International Year of Plant Health. Of course, a human biosecurity issue railroaded what had been a concerted international campaign by plant scientists to bring food security into the public domain. Animal biosecurity often makes the headlines owing to the potential human health impacts of animal diseases, for example, avian influenza and Japanese encephalitis. However, all of the world’s food production systems are ultimately plant-based, and failures in the biosecurity apparatus for plants can lead to catastrophic consequences. This workshop focuses on Plant Biosecurity risks and introduces new and emerging molecular technologies, applications, data collection and interpretation, and how they can be integrated into the existing quarantine apparatus to improve biosecurity outcomes for plants.

Presenter: Liz Collins, IBC Executive Officer/ Biosafety Officer (University of South Australia)  

                   Inspiring Preparedness Measures for Turbulent Times  (Tools to effect change)

                   Tuesday 31  October : 1/2 Day workshop 

Liz Collins

For 35 years Liz Collins has been involved in biomedical research, pathology services, laboratory management, research administration and biosafety. Liz has a B.Appl.Sci. (Med.Lab.Sc.) and for the past seven years has been the Biosafety Officer and IBC Executive Officer at the University of South Australia.

However, before becoming a scientist, Liz obtained an Associate Diploma in Social Welfare and worked as a counsellor and Social Worker. More recently Liz co-facilitated a torture recovery group. Still keen to learn more about what makes people tick, Liz continues her self-education and interest in sociology and psychology.

Liz Collins will invite workshop participants to

• Explore common blockages to change in behaviour, and
• Consider some tools to effect change

As biosafety and biocontainment professionals and regulators, we often instigate change.  And in these turbulent times, change is often thrust upon us, whether we like it or not. All of us face natural disasters, the potential development of harmful genetically modified organisms, biosecurity threats and many other challenges. Even in times of relative stability, organisational and technological change requires us to encourage others to act. But unfortunately, with low financial and staffing resources, and excessive workloads, staff in most biological research, educational and regulatory institutions frequently operate in fight, flight, fear and fawn mode: making leading people through change difficult.

Working in small groups, we’ll discuss some hypothetical situations ranging from establishing disaster preparedness plans, to how to get the phantoms to reply to your email. We’ll consider four tools: aesthetics, content, empowerment, and identity; and how we might apply these effectively.

Practical and down to earth, fun and encouraging; this workshop aims to empower participants to inspire safety, change and champions.

Objectives:

• Identify our common challenges.
• Describe four tools to effect change: aesthetics, content, empowerment, and identity.
• Empower participants to inspire safety, change and champions.

Suggested Background: Be yourself. Bring an enquiring mind.

Target Audience: Biosafety, biocontainment and biosecurity professionals, laboratory managers, training and compliance officers, regulators, laboratory directors and executives.

Presenter:  Stephen Coulter, Coulter Advisory and Richard Sale, Sale Laboratory Architecture Consultancy

                   Basic Laboratory design for non-designers

                   Tuesday 31st October 2023 (1/2 day)

Stephen is the founder and director of Coulter Advisory PTY LTD formed to provide specialist and independent design support and facility assessment for complex facilities.  With over 23 years experience working as a consulting engineer throughout the Asia Pacific region as well as further afield in pharmaceutical,  biological containment, specialist laboratory and specialist facility design consultancies Stephen has gained significant knowledge and understanding of the complex requirements of highly regulated specialist facilities.   

In his current role, Stephen is heavily involved working as a client advocate providing specialist facility design solutions and advice on technology intensive processes and facilities.  Stephen has a practical approach to the design, construction and hands on commissioning of these complex facilities.  Stephen adds meaningful value to both microbiological and engineering facets of the design by combining his engineering and biochemistry degree’s with his extensive diverse and international project experience.  Stephen is a Department of Agriculture Water and the Environment accredited third party assessor, a passionate and active participant in the regulatory requirements of the OGTR and the relevant Australian Standards as well as being an IFBA certified professional. 

As users of laboratory spaces we are often asked what we would like or what we need in a laboratory space to make it functionally work for us.  Some of us are fortunate enough to get asked to be involved in large new project builds.  While as users of the laboratory we don’t need to know all there is to know about laboratory design it can be useful to have a basic understand of the design principles so that we can provide meaningful input.  In this ½ day workshop Stephen will provide an overview of the standards that apply to all laboratory spaces, we will then work through principles of design for layouts, functional relationships, regulatory spatial requirements and then for the services required for the space.  Most of the workshop will be focused on basic laboratory design elements for chemical an microbiological laboratory spaces we will also cover containment requirements for Animal, Plant, Invertebrate and Aquatic facilities.

Presenter:  Gary W. Schmidt, PRI Bio, USA and Brett Cole, Biosafety Ltd, Australia and Mr Neil Slater, CSIRO ACDP 

                   Understanding and Verifying Thermal Treatment Systems 

                   Monday 30th October 2023 (1/2 day)

The workshop will work through the math involved in understanding and developing thermal treatment protocols and review several practical applications of the principles.  Verification methods and use of BioIndicators for Effluent Decontamination Systems, Carcass Treatment Systems and Autoclaves will then be reviewed individually.  The emphasis will be on developing a “working” understanding of these through various cases encountered in actual laboratory environments.  The attendee will gain an understanding of using different methods to develop treatment protocols and biological validation methods in differing environments as well as gain a thorough understanding of the math behind time/temperature relationships.   Intended for biosafety personnel as well as designers and specifiers of this type of equipment.

Presenter:  June Freeland and Lisa van Duin, The University of Melbourne

                   Auditing Biorisk Management Programs - What you need to know 

                   Tuesday 31st October 2023 (1 Day)

An audit is defined as a ‘systematic, independent and documented processes for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled’ AS/NZS ISO19011:2019, Section 3.1. 

Most biosafety (and related) professionals are familiar with carrying out institutional inspections of containment facilities, however it is also important to understand what is involved in conducting an audit to evaluate program performance. This allows us to better prepare for external audits as well as to identify our own system failures/non-conformities and determine appropriate corrective actions and areas for improvement. 

This workshop will include both theoretical and interactive sessions that cover the following learning objectives: 

• Understand the different types of audits 

• Be familiar with the process of audit planning activities such as developing an audit program, audit preparation, setting objectives, criteria & scope and developing an audit checklist 

• Be aware of the different approaches used to perform internal inspections and of surveillance programs that can be used to monitor activities involving biological materials 

• Understand how to best prepare, participate, and follow up on secondary audits conducted by an external party (such as a regulator) 

• Understand the requirements of a post audit meeting and the construction of a written report with defined outcomes and timelines. 

• Know what to consider when auditing a Biorisk Management System (a comprehensive approach to assess, control, mitigate, and ultimately manage risks associated with biological materials) based on ISO 35001:2019 

Presenter: Nathan Woods (MPI), Andrew Hill, Joshua Magor (ACDP), Gilles Tremblay (Merrick & Company) 

                   PC3 Facilities Workshop

                   Monday 30 October: 1 Day workshop 

The operation of containment facilities is complex, requiring multiple skillsets and knowledge to operate in a safe, compliant, and efficient manner. The integration of biosafety practice and biocontainment systems is key to the success of a containment facility. This requires a mutual understanding – scientific personnel to understand biocontainment and facilities personnel to understand biosafety.

The PC3 facilities course draws on the presenters shared experiences to provide an overview of Biosafety and Facility Operation and Maintenance (O&M) including:

·       Biorisk management relevant to O&M

·       Facility construction, leak rates and decontamination processes

·       Validation and monitoring of key physical containment systems

·       Reflections on best practices in facilities asset management and maintenance strategies for containment laboratories

It is intended that this workshop be an open and collaborative event with opportunity for participant involvement with discussion benefiting from collective experience.