EBSA21 Preconference courses

The pre-conference courses

The pre-conference courses on April 17 and 18 2018 will take place at the DTU the Technical University of Denmark. 

Anker Engelunds Vej 1 
2800 Kgs. Lyngby 
Denmark

All information on how to get there from the airport or the city center can be found here. 

 
A
The absolute essentials of biosafety
Ursula Jenal and Jörg Frank


Course description
The organization of biosafety and biosecurity in an institution where biological materials are handled, be it genetically modified or pathogenic, requires a broad range of competences and abilities by individuals who advise management and personnel on the safe and secure use of biological material. As of today, interested individuals gain these competences and abilities by a step by step learning and practical application process. The present course on absolute essentials of biosafety would like to serve as a starting point in this process.
Target audience
The workshop is suitable for all newcomers to biosafety and biosecurity generally interested or to be involved in biorisk management, potentially as biosafety advisor in an institution.
Learning objectives
The course mainly focuses on general principles and main issues related to biosafety and biosecurity thus conveying to participants the competence to be able to ask the right biosafety and biosecurity questions, to know where to look for information and to develop solutions together with scientists when confronted with risk issues in work situations where biological materials are used.
Main topics
General principles of biosafety and biosecurity, including principles of

  • biological and other hazards in the work area,
  • occupational health issues,
  • behavioral issues,
  • basics of biorisk assessment also indicating biorisk issues related to latest technologies in biological research,
  • good microbiological techniques,
  • personal protective equipment,
  • disinfection and decontamination,
  • waste management,
  • emergency preparedness and response.


Citation of the respective sections of CWA 16335:2011 Biosafety professional competence
The course presents the general importance and essential principles of section 7.2. and Annex C.2.1.2 on general principles of biosafety and biosecurity, 7.2.3 and C.2.1.2.1, biological and other hazards in the work area, 7.2.4. and C.2.1.2.2 occupational health, 7.2.5 and .2.1.2.3 human factors, 7.2.6 and C2.1.2.4 containment principles, 7.2.7 and C2.1.2.5 biorisk assessment and management, 7.2.11 and C.2.1.2.9 good microbiological techniques, 7.2.12 and C.2.1.2.10. personal protective equipment, 7.2.13 and C.2.1.2.11 infection control, disinfection, decontamination, and sterilization, 7.2.14 and C.2.1.2.12 biological waste management, 7.2.15 and C.2.1.2.13 emergency preparedness and response.

1 day
 
18 April 2018
9:00-17:00

Basic level

B
Risk assessment methodologies
Heather Sheeley and Toon De Kesel
 

Course 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. Also, 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.

Assessing the risk of such failures is essential with respect to incident and accident prevention. To this aim, application of the appropriate type of methodology of risk assessment such as Fishbone, HAZOP, LOPA, SWIFT, Kinney, FMEA, HACCP, Fault-tree, Bow tie, … is crucial. Even though these methods are applicable for all types of activities with biological material, this course is focusing on human- and animal-related work.

Target audience
The workshop is suitable for all interested and involved in doing thorough biological risk assessment, foremost BSOs facing new challenges regarding genetic modification, biocontainment facilities and complex work processes and situations in research and manufacturing.


Learning objectives
With this course the participant will not only understand the fundamentals and purpose of risk assessment, the terms used in relation to risk evaluation and the basic methods of risk assessment, but also be in a position to judge to what extent a risk assessment needs to be done, what type of methodology is appropriate and how to use the findings resulting from the risk assessment.


Main topics

  • fundamentals of risk analysis,
  • risk assessment in genetic engineering,
  • risk assessment in complex work situations,
  • purpose and terms used in risk evaluation,
  • advanced methods and applications of risk management


Citation of the respective sections of CWA 16335:2011 Biosafety professional competenceThe course draws on the CWA 15793:2011, specifically on section 4.3.1. on risk planning for hazard identification, risk assessment and risk control and some parts of section 4.3.3.1 on biorisk control objectives and targets.

2days

17-18 April 2018
9:00 – 17:00 both days
 
Max. 25 participants
 
Intermediate course
 
 
C
Bioethics: Social Responsibilities and Regulation
Anna Deplazes and Matthias Eggel


Course description
The aim of this course is to reflect on the rationale and benefit of science regulation in different research fields from a bioethical point of view.
We will start with a brief introduction to the aims and methodology of bioethics and the general relation between ethics and law. We will then focus on two particular topics: first, animal research, and second, research on imported genetic resources. The presentations will introduce the ethical issues in these fields and relate them to the legal regulation. One of the key questions will be to what extent the regulatory system enhances responsible conduct of scientists and in which respect it may have a contrary effect.
The course will include presentations as well as “workshop-sections”, in which the participants have the opportunity to discuss the topics based on concrete examples.
In the closing session we will relate these discussions to biosafety regulations and we will be particularly interested in the participant’s views and opinions on how biosafety regulation can increase scientist’s responsibility in awareness and scientific conduct.
Target audience
Biosafety professionals with a particular interest in bioethics and in reflecting on the purpose of science regulation.
Learning objectives

  • To provide a general understanding of the aims in bioethics and the difference between bioethics and law.
  • To discuss how ethical issues in research with animals and genetic resources have been considered in regulation.
  • To trigger reflection on the success and failure of science regulation with respect to increasing the awareness of scientists for their responsibilities and their responsible conduct.
  • To raise awareness for possibilities to increase scientific responsibility in the education on and implementation of biosafety regulation.


Main topics

  • Bioethics, responsibility of scientists
  • Responsible conduct in animal research
  • Responsible conduct in research with imported genetic resources
  • How can science regulation optimize responsible conduct in research?


Citation of the respective sections of CWA 16335:2011 Biosafety professional competence
C.2.1.3.3. Bioethics
The course will touch some other issues mentioned such as the Nagoya Protocol to the CBD (C.2.1.3.1) Laboratory animal experiments e.g. research with animals (C 2.2.1, C 2.2.2)

1 day
 
17 April 2018
9:00-17:00

Basic level

Max 20 participants

D
Emergency preparedness in a BSL3 (scenarios)
Jane Shallcross and Ant Crook
 
Course description

This is intermediate course is designed for those who are involved in writing plans for responding to emergencies involving BSL3 laboratories

Different types of emergencies that can be anticipated will be discussed – examining prevention, initial response, decontamination, return to normal and lessons learned.

This course will be interactive, and the role and limitations of a decontamination team will be discussed.

Target audience
People managing BSL3 laboratories or writing emergency plans for BSL3

Learning objectives

  1. Define a range of emergencies relevant to a BSL3 laboratory
  2. Apply your knowledge to initiate prevention, response and investigation strategies

Main topics

Prevention, response and Investigation of adverse events at BSL3

Citation of the respective sections of CWA 16335:2011 Biosafety professional competence

Objectives: The participant should be able to propose an emergency preparedness and response plan for a given situation. The participant should also be able to identify targets and weakness of a given facility, the resulting potential threats and how to mitigate them C.2.1.2.14  Incident  and accident investigation
Incident and accident fact collection, analysis and evaluation;
Record keeping, report writing and reporting;
Identify effective corrective actions

½ day
 
18 April 2018
9:00-12:30

Intermediate level

Max 12 participants

 

 

E
Developing PPE donning and doffing protocols for BSL3 (practical) 
Jane Shallcross and Ant Crook
 

Course description

This is an introductory course for those interested in the selection and use of personal protective equipment when applied to protection of workers in the Microbiological biosafety level 3 context. PPE will be described in relation to protection against routes of entry of pathogens and pros and cons of different types of PPE will be demonstrated and discussed.

We will practically examine how the PPE can be worn in combination, stored and decontaminated.

The selection of PPE for different types of BSL3 will be discussed and protocols for donning and doffing will be investigated using UV tracer dyes.

The instructors will bring examples of PPE with them, but please bring photos or information about any PPE you are thinking of using or have questions about.

Target audience
Biosafety advisors or laboratory managers deciding on PPE solutions for BSL3 laboratories who do not have any experience in this field or minimal experience.

Learning objectives

  1. Define the role of PPE, its limitations and benefits
  2. Recall potential routes of infection appropriate to a BSL3 laboratory and select from a range appropriate PPE to protect each route
  3.  Apply your knowledge about PPE to test donning and doffing methods for PPE

Main topics

  • PPE Fundamentals
  • Selection of PPE for different routes of infection
  • Testing donning and doffing methods for PPE

Citation of the respective sections of CWA 16335:2011 Biosafety professional competence

This course will cover aspects of CWA 16335 relevant to the BSL3 lab context, more specifically C.2.1.2.10;
Personal protective equipment (PPE), PPE fundamentals; Clothing
Gloves (lab, hot/cold, disinfectants); Face and eye protection; Respiratory protection (types, maintenance, training); Shoes and boots

½ day
 
18 April 2018
13:30-17:00

Basic level

Max 12 participants

 

 

F
Arthropods: Invertebrates – facilities and handling
Eva Veronesi and Julian Franklin
 

Course description

This course will provide researchers, biosafety professionals and facility managers an insight into the assessment of risk, design, operation and management of contained use activities involving arthropods.  This includes work with GMO’s and quarantine arthropods, as well as where they are vectors for pathogens, animal, human and plants. The ability to genetically modify arthropods as well as any associated pathogens has seen increasing use of facilities holding arthropods as well as facilities where the interaction of arthropods, pathogen and target host are being studied.

The course will enable the participant to:

  • Identify and understand the biohazards and risk associated with rearing arthropods
  • Understand the factors animal human health, environment, that should be considered when designing and/or assessing a facility used to rear arthropods as well as any associated pathogens they may carry.
  • Infection of arthropods with animal and human pathogens in accordance with biosecurity regulation.

Get a practical view on the operation and management of such facilities including the management of waste, incidents and emergencies.

Target audience

  • Biosafety Practitioners responsible for facilities housing arthropods.
  • Managers responsible for facilities housing arthropods.
  • Researchers working with arthropods wanting an overview of the biosafety requirements of working with arthropods.
  • Engineers, Designers, Facility managers requiring an understanding of the management and Biosafety requirements of housing arthropods.

Learning objectives

  • Identify and understand the biohazards and risk associated with rearing arthropods
  • Understand the factors animal human health, environment, that should be considered when designing and/or assessing a facility used to rear arthropods as well as any associated pathogens they may carry.
  • Infection of arthropods with animal and human pathogen in accordance with biosecurity regulation.
  • Get a practical view on the operation and management of such facilities including the management of waste, incidents and emergencies.

Main topics

  • Regulatory framework
  • Risk assessments of facilities with Arthropods, including associated pathogens or GM characteristics they may carry.
  • Arthropods and plants
  • Arthropods and animals/people.
  • Arthropod facility, design considerations.
  • Operation of Arthropod facilities and waste management.
  • Incident management

Citation of the respective sections of CWA 16335:2011 Biosafety professional competence

C 2.1.2.4 Containment principles
C 2.1.2.6 General principles of environmental Safety
C 2.1.2.7 Facility design, construction, commissioning, validation, operation and maintenance.
C.2.1.2.12 Biological waste management
C.2.1.2.13 Emergency preparedness and response

Above as applied to Arthropod Facilities.

Specialist training

C.2.2.5 Working with Arthropods

  • Fundamentals of working with Arthropods.
  • Facility Design and containment requirements related to Biosafety and Biosecurity issues.
  • Biosecurity issues associated with the use of arthropods.
  • Occupational health issues associated with the use of arthropods.
  • GM Arthropods.
1 day
 
17 April 2018
9:00-17:00

Basic level

Max 20 participants

 

 

H

The User Requirement Specification (URS): How to start it right, keep it ship-shape not pear-shaped, and arrive at a happy ending
Niel Walls and Mark Wheatley


Course description
The course is aimed at biosafety people and others desiring to create User Requirement Specifications (URSs) which optimize the ability to create successful outcomes.
It is proposed that the course will include significant participant interaction. The instructors will prepare and use an appropriate mixture of case studies and realistic scenarios to improve the understanding of participants by direct involvement and feedback.
The instructors intend to prepare a short questionnaire prior to the course date. Registered participants will be invited to provide responses approximately 2 weeks prior to the course date. The answers to this questionnaire will be used to focus the course on areas that participants see as important.
Target audience

  1. Biosafety professionals
  2. Regulatory and compliance officers
  3. Institutional facilities and services people involved with construction and remodeling of biological laboratories and facilities
  4. Design and construction professionals seeking to improve knowledge related to biosafety/biocontainment/biosecurity aspects of laboratories and containment facilities.
  5. Users with requirements which need specifying


Learning objectives

  1. Understand what a URS is and what it is not
  2. Understand the appropriate roles of biosafety professionals, facilities officers, designers and builders in the preparation, interpretation and realization of the URS- understand the evolution of the process
  3. Understand different building design and construction “models” and how these affect the nature and timing of the URS
  4. Look at how to prepare a good URS and how to avoid preparing a bad one
  5. Understand how to manage change such that “value management” is not used solely to reduce cost


Main topics

  1. The URS
    What it is, what it is for, when it should be prepared Who should participate and their roles How it should be managed; evolution & change control
  2. Different building procurement strategies– how this can affect the URS
    Why different procurement strategies can affect the URS Effect on function, suitability, safety, security and compliance When equipment should be selected and how it should be procured How to ensure changes only occur with due consideration of consequences
  3. URS Finalization and Delivery
    Confirmation that the URS has been delivered appropriately Who should support and confirm this process


Citation of the respective sections of CWA 16335:2011 Biosafety professional competence
C.2.1.2.7 Facility design, construction, commissioning, decommissioning, validation, operation and maintenance
Objectives: The participant should be able to, understand the construction commissioning and validation processes and have knowledge of basic design features of the most important types of facilities. The participant should be able to consider the biosafety and biosecurity issues in preventive and corrective maintenance, operations and decommissioning

1 day
 

17 April 2018
9:00-17:00

 

Basic level

Max. 24 participants

I
Training must be fun – a comprehensive introduction to teaching convincingly
Per Staugaard and Vibeke Halkjaer-Knudsen


Course description
This is a highly interactive course.
The trainers guide you through the maze of making a training program, fit for the audience; including an introduction to various ways of teaching, organizing group work and evaluation of training. You, the participants in this workshop, are supposed and requested to contribute with your own experience [from specific training, from risk based behaviour, and from general life experience].
Target audience
All that presently are, or in the future will be, involved in organizing training and teaching in courses in the field of biosafety.
Learning objectives

  1. Participants can set up a training program
  2. Participants can choose from a set of training tools to optimize their training
  3. Participants increase the long lasting effects of their training courses


Main topics

  1. Define training needs - leading to a training program
  2. Various ways of teaching / training / mentoring
  3. Evaluation of training
  4. How to make your training ‘sticky’


Citation of the respective sections of CWA 16335:2011 Biosafety professional competence

  • 7.2.20 Training
  • 7.2.21 Communication [transfer of messages]
  • 7.2.4 Human factors [influence on behaviour]
1 day
 

17 April 2018
9:00-17:00

Max. 17 participants

 

 

 

J
BSC – making the most of it
Felix Gmunder and Søren Thuesen


Course description
Biosafety cabinets are the most important and most widely used primary containment equipment in microbiological and biomedical laboratories (BSL-2, BSL-3 and BSL-4) for the protection of workers, the environment and the product. Cabinet efficacy depends on the selection of appropriate type and size of the cabinet, proper function, correct placement of the cabinet in the laboratory, and how the work in the cabinet is organized and carried out. Biosafety cabinets need maintenance and testing at regular intervals. The course covers the topics and administrative controls compliant with CWA 15793 and international biosafety guidelines (containment principles, selection, validation, certification and maintenance). It starts with the biosafety laboratory containment principles before focusing on the technical background of the types of biosafety cabinets available on the market, and their strengths and limitations before focusing on safe work procedures and practices. Finally, practical demonstrations serve to clarify the flow of air and sample laboratory procedures and practices when working in the cabinet. Participants will work in groups to analyze, discuss, and comment the procedures shown and suggest improvements and alternatives.
Target audience
Biosafety Professionals, Biosafety Officers, Lab Managers/Technicians, Scientists, Engineers
Learning objectives

  • Understand different types of biosafety cabinets, laminar flow hoods and their applications.
  • Learn how to place and operate biosafety cabinets from the user's and biosafety perspective.
  • Understand installation and maintenance test procedures.
  • Learn how to organize your work in the cabinet (loading cabinet until conclusion of work and unloading).
  • Group exercises: Analyse and discuss several examples of procedures and workflows


Main topics

  • Biosafety cabinet /flow hood engineering and function
  • Cabinet selection, procurement, placement, maintenance, testing
  • Laboratory work in the cabinet from the biosafety perspective


Citation of the respective sections of CWA 16335:2011 Biosafety professional competence

  • C.2.1.2.4 - Containment principles
  • C.2.1.2.7- HEPA (High Efficiency Particulate Air) filtration (room and Biological Safety Cabinet (BSC)
  • C.2.1.2.8 - Selection, validation, certification and maintenance of equipment
1 day

17 April 2018
9:00-17:00

Intermediate level

max 19 participants

K
Behaviour-based (bio)safety
Jan-Piet Tijssen and Cathy Bakker 


Course description
This course intends to inspire you. To convince you that safety not only pays (for you and the company), but also is fun and moreover a serious profession. A profession that involves many areas of knowledge and a multitude of skills, amongst others those dealing with human behaviour.
The course will get you thinking about how to convince and motivate others. Co-workers but also, not in the last place, the management. Not just words and rulings, but setting the example is of utmost importance.
It’s about how to influence behaviour, when to apply punishment or reward, how to make the safe way the most attractive and apart from preventing accidents, also to learn from near misses and get to the root causes.
Cathy is a biosafety officer and Jan-Piet is an inspector. Roles that are not conflicting but rather support each other. Together with you we hope to further explore this difficult subject of human behaviour in relation to biosafety.
Target audience
All who are interested in improving the (bio)safety culture in their working environment and organization.
Learning objectives

  • Awareness of safety culture and behaviour
  • Tools to change and improve culture and attitudes
  • Tools to improve safety: introduction to (Black) Bow Tie Analysis


Main topics

  • Safety and culture, a definition
  • Tools for change and improvement (punish and/or reward)
  • (Black) Bow Tie analysis: What can go wrong and why has it gone wrong


Citation of the respective sections of CWA 16335:2011 Biosafety professional competence
The workshop relates to several issues addressed in CWA 16335:2011, especially some of those addressed in:

  • C.2.1.2.3 Human factors
    • Behaviour-based safety
    • Working in a team;
  • C.2.1.2.7 Facility design
    • The design team (architects and engineers, principal investigators, users, management, safety, maintenance, communication);
  • C.2.1.2.14 Incident and accident investigation
    • Incident and accident fact collection, analysis and evaluation
    • Identify effective corrective actions.
  • C.2.1.2.15 Biorisk management programme
    • Understand the principles of management systems;
    • Responsibilities within the hierarchy (including managers and committees);
    • Policies,
    • Audits and inspections – principles;
    • Training programme
    • Communication and motivation skills;

1 day

18 April 2018
9:00-17:00

Basic/Intermediate level

max 20 participants

 

L
Sharing experiences on the implementation of a biorisk management programme
Juergen Mertsching and Urs Pauli


Course description
Breaches of biosafety and biosecurity have emphasised that management failure is normally the root cause of accidents and incidents with biological agents and toxins. The CWA 15793:2011 "Laboratory Biorisk Management” is an internationally recognized management document to specifically address hazards associated with laboratories where biological materials are handled at all containment levels. It is a compendium of all biosafety issues which defines key requirements and can help organisations to manage these risks by integration into the P-C-D-A-cycle driven management system(s) in place or to be developed in an institution. This 1-days-course will be the platform for discussion of the 16 components of a biorisk management programme and how participants have started the implementation of these elements at their home institution:

  1. Biorisk management system (e.g. roles and responsibilities)
  2. Risk Assessment
  3. Pathogen and Toxin Inventory
  4. General Safety
  5. Personnel and Competency (e.g. training and briefing)
  6. Good Microbiology Technique
  7. Clothing and personal protective equipment
  8. Human Factors
  9. Healthcare (e.g. post exposure prophylaxis)
  10. Emergency response and contingency plans
  11. Accident and incident investigation
  12. Facility physical requirements
  13. Equipment, maintenance and calibration
  14. Disinfection and decontamination
  15. Transport procedures
  16. Biosecurity

To optimize the individual benefit, the participants will be contacted in advance and will be asked to give a short presentation on their experience with implementation of one of the listed elements.
Target audience
The target group for the 1-day course are advanced biosafety professionals who are willing to share their experience during implementation of a biorisk management for their respective home institutes and who want to learn from the experience of others to continuously improve on their program
Learning objectives
The course participants will get a deeper insight on:

  • How other institutions have implemented a biorisk management system and which problems they have encountered during the process
  • Alternative implementation strategies in the different environments
  • How to assess the progress of implementation in their home institution


Main topics

  • Intent of the CWA 15793:2011 for Implementation of a biorisk management system
  • Implementation strategies for a biorisk management in different environments
  • Evaluation of implementation strategies for effectiveness


Citation of the respective sections of CWA 16335:2011 Biosafety professional competence
This course refers to competence 7.2.17 and training specifications C.2.1.2.15 of CWA 16335:2011 Biosafety professional competence.

1 day

18 April 2018
9:00-17:00

Advanced level

Max. 15 participants

 

 

M
Large scale GMP and containment, do disposables fit in?
Anneke Griffioen and Vibeke Halkjaer-Knudsen
 
Course description

Manufacturing protocols have particular focus on good manufacturing practices (GMP) aiming at product safety. Biosafety professionals need to understand the differences and how to communicate with GMP professionals about biosafety and biosafety measures. This course provides insights on where GMP and biosafety meet or diverge, where balance needs to be established.

Target audience

Biosafety professionals confronted with introduction of disposables, design new lab or production facility
Enigineers working in a BSL 2 or higher environment

Learning objectives

Understanding of balancing GMP and biosafety
Are disposables suitable in your situation

Main topics

  • Use of disposables: safe use for product and environment
  • Waste streams
  • Connection points
  • Measures required for maintenance

Citation of the respective sections of CWA 16335:2011 Biosafety professional competence

  • The topic refers to some sections of competence 7.2.6 and training specifications C.2.1.2.4 Containment principles and specialist training specification C.2.2.8 biosafety and Good Manufacturing Practices (GMP)

1 day

18 April 2018
9:00-17:00

Basic level

Max. 20 participants

N
Allergies and toxins from animals, plants and microorganisms-think outside of the box
Martin Kuster and Katrin Zimmermann


Course description
Handling biological materials in research and development, as transporting them has implications on several levels. While the hazardous situation is not always obvious, potential consequences can be very serious. Participants will discuss several case scenarios involving

  • Large scale production of microorganisms
  • Research work with pathogens and toxins
  • "Field work"
  • Greenhouse activities
  • Laboratory animal allergens

It is expected that participants share their knowledge about hazard identification, risk assessment and risk management strategies with regards to the topics discussed. The goal of the course is to broaden the thinking and knowledge of the participants in the field of biosafety and biosecurity. A specific focus will be on understanding the network of the biosafety officer, in order to recognize, assess and manage unusual risks. The cases focus on assessing the risk and implementing mitigation and safety measures when handling material that can be toxic, can cause allergies or has properties that must be considered for safe handling.
Target audience
Biosafety Professionals, HSE-Officers, Personnel in biological Research, Development or production.
Additional Information: Participants should download the pre-reads from the EBSA web-page. Also, it is recommended that participants bring their own lap-tops to the course, so that there is at least one per working group.
Learning objectives
Using case studies, participants will work through the PDCA cycle as set forth in CWA-15793:2011. After the course, people should have an in-depth understanding on how using a systematic approach will help finding infrequent hazards and manage the corresponding risks.
Main topics

  • Risk assessment and risk management, based on the PDCA cycle for large scale production, research and development, public health impact.
  • Plant health, human health, environmental safety
  • Dual use issues in biosafety


Citation of the respective sections of CWA 16335:2011 Biosafety professional competence

  • C.2.1.2 Principles of biosafety and biosecurity:
    • C.2.1.2.1 Biological and other hazards in the work area
    • C.2.1.2.5 Biorisk assessment and management
  • C.2.1.2.2 Occupational health and biosafety
1 day

18 April 2018
9:00-17:00

Intermediate level

Max. 24 participants