EBSA17 Preconference Courses 2014

Course A - Better biological risk assessment using appropriate methodologies and tools

Course Instructors

Ursula Jenal, Jenal & Partners Biosafety Consulting, Rheinfelden/CH
Toon De Kesel, Bayer CropScience, Ghent/B
Heather Sheeley, Public Health England, UK

Description

Management of risks related to activities with hazardous biological material, be it research, development, production or diagnostics, requires risk assessment at various stages of the activity. To begin with, the hazards of the various biological materials need to be estimated. When genetic modification is involved methods and tools such as viral vectors, plasmids and types of inserts need to be considered. At a second stage biosafety and biosecurity measures need to be evaluated for their ability to contain the biological material. These measures on their own, whether organizational or technical, have their weaknesses and might be vulnerable to failures which need to be taken into account in incident and accident prevention. Advance application of several techniques (such as Fishbone, HAZOP, LOPA, SWIFT, Kinney, FMEA, HACCP, SSQ, Fault-tree, Bow tie, Brenner … ) to manage and assess risk especially in the areas of genetic modification, materials that have an insufficiently defined risk or information, animal and plant related work.

With this course the participant will understand the fundamentals of risk analysis and purpose and the terms used in risk evaluation, be able to use basic methods of risk assessment, know when to do a risk assessment and what type, be able to identify more advanced methods and applications of risk management and know how to use the finding of the assessment of risk. The course will cover these aspects in introductory presentations and case studies. Participants are asked to actively participate in the course by bringing their own risk assessment questions and work situation up for discussion. Group work would be highly facilitated by participants bringing their own laptops.

Learning Objectives

  • Understand and apply the basics of risk assessment
  • Identify when the risk assessment process need to be more robust
  • Understanding of terms and approaches
  • Ability to identify appropriate methodologies and when to use them

Course B - Auditing: a comprehensive and practical introduction

Course Instructors

Helmut Bachmayer, Biosafety & Biosecurity Consultant, Maria Enzersdorf/A
Gary Burns, Biosafety & Biosecurity Consultant, Congleton/UK

Description

This two day practical course provides a comprehensive and sound practical introduction to auditing. The course takes participants through the principles, recognized best practices and essential techniques of (HSE / biosafety) auditing. It provides them with guidance on planning and performing of an audit in line with international standards The course will combine elements previously covered in the one day EBSA pre-conference courses "Biosafety audits and inspections - a basic course" and "Auditing - beyond the basics". Newly introduced feature will include the opportunity for delegates to take part in a "mock audit" of a laboratory facility.

The course will be of interest to those with no or limited auditing experience and / or formal training. It will set out the principles of effective (bio)safety, health and environmental auditing and compare and contrast this with inspection approaches. The trainers will explain how to prepare, structure and conduct an audit by sharing with the participants their extensive auditing experience in the areas of HSE / biosafety. They will point out potential pitfalls as well as good practices including communication and interviewing skills, and drafting of audit reports. The course will be highly interactive and practical with focus on syndicate work in break out sessions and exercises including simulation of audit opening and closing sessions, interviewing as part of desk-top reviews and facility walk-throughs, and drafting of an audit report.

At the end of the two day training course delegates will understand the elements of an audit system and program, they will know the essential tools and realize behavioural implications. The course should enable delegates to plan and carry out audits of small facilities within the context of their own work experience, and to contribute to the planning of as well as participate as a team member in HSE / biosafety audits of a more complex nature lead by an experienced auditor.

The class size is strictly limited to 12 participants to ensure productive interactions (syndicate work in break out sessions and plenary discussions).

Course C - Design and implementation of a biorisk management system

Tuesday and Wednesday, 13 - 14 May 2014 (9:00 - 17:00)

Course Instructors
Jürgen Mertsching, Hannover Medical School/D
Urs Pauli, Institute of Virology and Immunoprophylaxis, Mittelhäusern/CH

Recent breaches of biosafety and biosecurity have emphasised that management failure is normally the root cause of accidents and incidents with biological agents and toxins. Implementation of a systematic biorisk management system, e.g. adopting the CWA 15793 can help organisations manage these risks. The CWA 15793:2011 "Laboratory Biorisk Management" is the first internationally recognized management document to specifically address hazards associated with laboratories where biological materials are handled at all containment levels. With respect to individual state legislation, CWA 15793 is a compendium of all biosafety issues irrespective of actual laws or administrative provisions. It defines key requirements encompassing all relevant laws and does not focus on the application of individual pieces of legislation and by thus does not contradict any existing guidelines.

 The 2-days-course will start with the introduction of the principles of a biorisk management and how the multiple components of a biorisk programme can be integrated into the management system(s) in place or to be developed in an institution. Participants will be asked to give a short presentation of their institution at the beginning of the course. The main emphasis of the two days will be the opportunity for the participants to work on a scheme for implementation of a biorisk management for their respective home institutes.

The course participants will be able to:

Identify the fundamentals of a biorisk management system
Understand the intent of the CWA 15793:2011 with emphasis on:

  • Plan-Do-Check-Act cycle
  • Policies
  • Documentation control
  • Hazard identification & risk assessment (incl. risk control)
  • Operational control
  • Emergency response and accident and incident investigation
  • Training, awareness and competence

Initiate or improve the implementation of the CWA 15793:2011 for their institution

To optimize the individual benefit, the course instructors will contact the participants in advance to recommend which information of their home institutions the participants should bring along (if available).

Course D - Biosafety in plant growth & plant pathogen facilities

Course Instructors

Delphine Beeckman, Bayer CropScience, Ghent/B
Rene Custers, VIB, Zwijnaarde/B
Julian Franklin, Rothamsted Research, Harpenden/UK

This 1.5 day course aims at providing researchers, biosafety professionals and facility managers a practical insight into the assessment of risk, design, operation and management of contained use activities in plant growth and plant pathogen facilities. This includes work with GMOs (plants, (non-)pathogenic micro-organisms, invertebrates) as well as with (quarantine) pests and diseases.

The learning objectives are:

  • To be able to identify and understand the biohazards and risks associated with growing plants and plant pathogens.
  • To understand the factors that should be considered when designing and/or assessing a facility used to grow plants and plant pathogens.
  • To generate a practical view on the operation and management of such facilities, including the management of waste and incidents.
  • A visit to two plant growth facilities is included in the course to demonstrate structural and operational measures aimed at maintaining containment and plant health.

Topics that will be addressed during the course include:

  • Legislation
  • Risk assessment of the organisms and the activities
  • Facility design and assessment
  • Facility management and operations
  • Quality and hygiene management
  • Waste management
  • Incident / emergency management

Course E -Animal facility operations

Course Instructors

Karen van der Meulen, University of Ghent/B
Piet Dierckx, Janssen R&D, Beerse/B

Course Programme

All participants are requested to submit a case study maximum two weeks before the conference to karen.vandermeulen@ugent.be.

The pre-conference course on "Animal facility operations" aims at biosafety professionals that are or will be involved in activities with small and/or large animals at different containment level. The main driver of the course is the question how the interaction between animal, pathogen and experimental set-up affects biosafety and biosecurity.

During the course, there will be classroom presentations by the course instructors and extensive discussions of case studies in discussion groups. For the latter, all participants are requested to submit their case study related to biosafety in animal facilities maximum two weeks before the conference to karen.vandermeulen@ugent.be. A template for the case studies will be provided by the EBSA secretary upon registration for the course. Additionally, a visit is scheduled to the Veterinary Research Building at the Faculty of Veterinary Medicine, Ghent University. This building will accommodate BSL2 and 3 laboratories and housing for large animals. It is currently under construction and will become operational early 2015.

At the end of the course, the participant should be able to:

  • understand the impact of working with animals on biosafety (and biosecurity) management, including risk assessment and risk management,
  • define the specific biorisks,
  • understand and apply appropriate biosafety (and biosecurity) measures related to experimental set-up and procedures in animal studies, as outlined in CWA 16335:2011.

Main Topics:

Risk assessment in facilities with experimentally infected animals
How working with animals affects biosafety
Occupational health issues associated with the use of animals
Risk management in facilities with experimentally infected animals
Animal care and use
Housing and containment of experimentally infected animals

Course F - Biocontainment principles - includes primary and secondary systems

Course Instructors
Uwe Müller-Doblies, Institute for Animal Health, Pirbright Surrey/UK
Felix Gmuender, Basler & Hofmann Singapore Pte Ltd/SG  CV

Biocontainment constitutes the combination of engineering controls and infrastructure that support and complement the biosafety protocols adopted in biocontainment laboratories. The World Health Organisation and the International Animal Health Office (OIE) are advocating a more risk based approach, and are moving away from established biocontainment levels based on pathogen risk groups. This changed approach will provide more flexibility, but will at the same time require more effort to justify the risk based choice of controls. The course is providing an overview of biocontainment systems and their performance as risk control systems. The aim is to equip participants for the dialogue between regulators, designers and facility owners/users.

Course G - Laboratory acquired infection - updates and lessons learned

Course Instructors
Heather Sheeley, Public Health England, Salisbury /UK
Dana Brehar-Cioflec, National Institute of Public Health, Timisoara/RO

The purpose of biosafety is to prevent exposure to biological agent especially that which leads to infection. It is therefore important to know the causes and circumstances in which laboratory acquired infections occur in clinical, veterinary and research work and the lessons learned from those. Participants in this course will gain an appreciation of the historical and current trends in laboratory acquired infections. Using case studies and real examples, participants will assess the risks, and identify mitigation and prevention strategies.Through group work participants will identify and develop the biorisk management concepts to ensure prevention, medical response and investigation for laboratory acquired infections.

Main Topics

  • Historical and current trends in laboratory acquired infections
  • Role of previous incidents in risk management
  • Reporting systems
  • Response planning including medical support
  • Incident investigation

Course H -Design for biological facilities - how to be an 'intelligent customer'

Course Instructors

Philippe Stroot,  Xibios Biosafety Consulting, Tournai/B
Mark Fitzgerald, HDR Architecture, Atlanta, GA/USA
Neil Godden, Public Health England, Salisbury/UK

Building new containment facilities or revamping existing biological laboratories is generally an important step in the development of an organization. It is also a challenge for all those involved in the project, including the laboratory users and the biorisk management advisor. However, contrarily to design professionals, most users and biorisk management advisors are only confronted with major design and construction projects once or a very few times in their career. In such a context, this training course will aim at familiarizing biosafety professionals with design and construction, and providing them with the understanding, knowledge and tools that will help them to apprehend the design of small or large biological facilities in an informed and effective way. It will help them, in particular, to assist the facility owner and users in the definition of their needs and their choices, and to deal with the project architects and engineers.

Some more specific outcomes of this one-day training course will be:

  • to know and understand the roles and interests of the various stakeholders in a design and construction project, with a special focus on the role and responsibilities of the biosafety professional;
  • to know and understand the project management process, including the types of contracts, the definition of the users needs and requirements, the various phases of design and construction, the development of specifications, the commissioning, and the people involved;
  • in particular, to understand the role of commissioning and validation, and the importance of a validation strategy and plan;
  • to be able to read and interpret drawing and blue prints;
  • to be able to manage communication with the users, designers and engineers;
  • to understand warrantees and maintenance around new facilities and equipment.     

Exercises will include reading drawings, problem solving and case studies.

Course I -Biosafety contribution to responsible science

Course Instructors

Tim Trevan, International Council for the Life Sciences, McLean, VA/USA
Gavin Macgregor-Skinner, The Pennsylvania State University, Washington, DC/USA

The vast majority of biologists enter the field because they have a passion to make the world better by understanding organisms and the systems they live in.  We dream of improving the world's health through combatting disease, improving nutrition and protecting species and the environment.

But research into and exploitation of biology can both intentionally and unintentionally cause damage to these very things in a variety of ways.  Indeed, surveys repeatedly tell us that most biologists are unaware or have not given full thought to all the ways in which their work could be misused.  Work on pathogens, invasive species and novel DNA are obvious candidates for additional security and safety considerations, but so too are many of the enabling techniques and technologies.

International concern about the misuse of biological agents, has led authorities to develop extensive biosecurity measures based on physical, personnel and data restriction. In contrast, the scientific community is about the open and free exchange of ideas and sharing of methods and discovery.  This is especially so in the microbiology community working to counter the threat of infectious disease outbreaks. This sharing and publication has brought biosecurity concerns, about what work should be conducted, how it should be approved, who should be trained in specialist techniques in microbiology, what should be published and how is this policed.

This course explores the issues, gives examples of managing the risk and would be relevant for those working in biodefence, global security, policy-making, institutional biosafety/biosecurity, synthetic biology/GMOs, or the education of scientists.

Course J - Introduction to behavior-based safety

Course Instructors

Alain Pardon, IMEC, Leuven/B
Patrick Seechurn, University of Manchester/UK CV [PDF Icon]

This introductory course is for  safety professionals or managers having +5 years of professional experience. In this highly interactive course attendees will systematically gain insight in the principles of behavior based safety and gradually learn to set up the foundations of a behavior based safety management system. Attendees will receive some practical guidance on how to promote safe behavior.

To conclude, a model of a behavior based safety management system will be presented.

This is a highly interactive course with a large portion of teamwork.

Main topics:

  • Principles of behavior based safety
  • How to identify at - risk behavior
  • Analysis of at-risk behavior
  • Promoting safe behavior