In-person Professional Development Courses

All times listed are in MOUNTAIN STANDARD TIME

November 1-3, 2024
JW Marriott Phoenix Desert Ridge, Phoenix, Arizona

Basic Level Courses – For those new to the profession or would like training in a particular topic.

Intermediate Level Courses – For those with basic knowledge or would like to learn more.

Advanced Level Courses – For those with experience or looking for a challenging course.

Friday, November 1, 2024, 8:00 AM – 5:00 PM

1. BSL-3 Operations and Management

This course will review the important aspects of BSL-3 Operations and Management from two points of view; “hardware” (i.e., facilities & equipment issues) and “software” (i.e., administrative controls). It will cover various aspects you need to consider in order to operate a BSL-3 facility, such as training, maintenance support, occupational health, waste management, maintenance, performance verification, and emergency response. The instructors will encourage interaction and the exchange of experiences among the attendees. Regulatory aspects from any specific country, or planning, design, or construction-related issues will not be covered.

Objectives:

• Describe the elements of BSL-3 Operations and Management (risk management, primary barriers, annual performance verification, emergency response, etc)
• Recognize institutional, management, and user responsibilities
• Summarize approaches to developing manuals, SOPs, and training

Suggested Background: Basic Risk Assessment and familiarity with BSL-3 Concepts
Target Audience: Safety Professionals, BSL-3 Managers, Containment Engineers, Lab and Scientific Directors

Audience Level: Basic

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Friday, November 1, 2024, 8:00 AM – 5:00 PM

2. IATA Infectious Substance Shipping Certification

This course is appropriate for those who have some experience with infectious substance handling or shipping but may not have been certified within the past 3 years and those with little to no previous training. The course utilizes several facilitated learning activities. There will be group discussions and interactive exercises focused on the essential areas of infectious substance shipping. New IATA requirements for competency assessment will be administered short interactive assignments, and an online exam. Participants will mark, label, package, and complete documentation for infectious substance shipments (Category A, Category B, and Exempt Patient Specimens), and review applicable regulations with a focus on IATA. Additional U.S. DOT differences will also be addressed. This course is appropriate for those responsible for packaging, marking, and labeling shipments of all categories of infectious substances, dry ice, and liquid nitrogen. Participants have both an online exam (score at least 80%) and practical exercises to complete to demonstrate competency. Successful completion of the course will qualify attendees for IATA/DOT certification.

Objectives:

• Review and restate shipping regulations for both air and ground with a particular focus on 49 CFR US DOT and IATA air regulations
• Conduct a risk assessment and be able to properly classify and identify infectious substances for transport purposes
• Package, mark, label, and prepare documentation for shipments of infectious substances to meet regulatory requirements for air and ground shipments

Suggested Background: None
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers

Audience Level: Basic

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Friday, November 1, 2024, 8:00 AM – 5:00 PM

3. Basic Risk Assessment

Rapid scientific and technological advances continue to challenge the biosafety community in determining and establishing the practices and containment necessary to avoid exposure to hazardous biological agents and materials found in the laboratory. This introductory course will provide an opportunity to incorporate the basic knowledge and skills necessary to perform risk assessments for working safely with pathogens (human and animal) and rDNA (genetically modified organisms or viral vectors). Using case studies, attendees will work together to conduct risk assessments by determining the hazards involved; the appropriate questions to ask to address the potential risks associated with the intended activities and make recommendations on appropriate containment and practices required to work safely. Each group will present their conclusions from the activity.

Objectives:

• Identify and list determinants for assessing risk (host, environment, agent)
• Complete the steps of a risk assessment and determine steps to manage risk (mitigation)
• Identify resources and references for risk assessment/management

Suggested Background: None
Target Audience: New Biosafety Professionals, Laboratory Workers

Audience Level: Basic

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Friday, November 1, 2024, 8:00 AM – 5:00 PM

4. Intersection Between Biosafety and Infection Control: An Introduction to Infection Control and Biosafety in Clinical Spaces

This course is meant for the biosafety professional who would like to learn more about application of biosafety principles in the clinical environment and partnering with Infection Control Departments in health systems. This is increasingly important as clinical trials using biological therapeutics, such as human gene transfer (HGT), require safety professionals to develop investigational product handling, preparation, and administration protocols that align with current clinical safety practices and environments. The goals of this course are to introduce different clinical environments, specific biosafety considerations for each space, hospital regulatory requirements that influence safety protocols, and how to collaborate with hospital infection control professionals to operationalize safety protocols in a way that’s meaningful to hospital staff.

Objectives:

• Describe inpatient, procedural and outpatient clinical environments and how this affects implementation of Biosafety Practices
• Restate the similarities and differences between biosafety levels, isolation precautions and standard precautions
• Summarize how NIH and BMBL guidelines relate to hospital regulatory and accreditation requirements when creating protocols for HGT clinical trials

Suggested Background: Principles and Practices of Biosafety^® (PPB), Risk Assessment
Target Audience: All Safety Professionals, All Biosafety Professionals

Audience Level: Intermediate

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Saturday, November 2, 2024, 8:00 AM – 5:00 PM

5. Facilities Fundamentals for Biosafety Professionals

This course is aimed at strengthening biosafety professionals knowledge of how facility operations support overall biocontainment operations. The first portion of the course will familiarize attendees with the general concepts biosafety-related facility design and their roles in it, along with the fundamentals of HVAC system operation in the context of BSL-2 and BSL-3 facilities. Topics in this portion of the course include: the role of biosafety personnel in biocontainment facility design, renovation, and operations, understanding design drawings and related construction documents, what the relationship is of facility features to biosafety levels, and HVAC components and their function relative to biocontainment. The instructors will lead discussions of more detailed aspects of containment facilities and their operation, including: specific infrastructure, equipment, and systems related to operation of a biocontainment facility; autoclave function, waste management, associated facility infrastructure; room decontamination in relation to facility components; interactions between facilities and containment equipment; security, operations, and biosafety. Through a mixture of presentations from experts in the field and interactive exercises, attendees will reinforce their knowledge of facility system function and their roles in facility design, construction, and operation. The target audience for the course is biosafety professionals who come with backgrounds other than facilities, and it is open to both newcomers and seasoned veterans in the field.

Objectives:

• Restate the roles of biosafety professionals in facility design and operation
• Explain practical approaches for reviewing design documents.
• Describe the function of discrete facility infrastructure, equipment, and systems related to biocontainment facility operations

Suggested Background: BSL-3 Operations and Management, Fundamentals of Biosafety, Principles and Practices of Biosafety^® (PPB)

Target Audience: All Biosafety Professionals, All Safety Professionals

Audience Level: Basic

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Saturday, November 2, 2024, 8:00 AM – 5:00 PM

6. Articulating the Value of Your Biosafety Program

A recurrent challenge confronting biosafety professionals is the ability to garner necessary program resources to achieve desired goals and objectives. The basis for this difficulty is that, on a good day in the world of biosafety, “nothing happens”. The underlying challenge is that upper management may not fully appreciate or understand all the effort and resources that went into making “nothing happen”. Biosafety professionals in particular experience difficulty in this regard because many in the profession have received intensive training in the biological sciences, but little or no training in the area of program management. This course focuses on some key management approaches and techniques that can be used within biosafety programs to help improve stakeholder understanding, which in turn can result in the provision of necessary programmatic resources. Numerous real-world examples of successful applications of the techniques presented will be displayed for review and discussion. Ample time will be provided throughout the course for attendee interaction and inquiries.

Objectives:

• Identify various biosafety programmatic measures and metrics that should be captured and communicated
• Paraphrase the techniques that can be used for displaying biosafety data in ways that others can readily understand and appreciate it
• Describe how biosafety programs can assist with other basic safety program needs to help avoid the notion of program duplication of efforts and to improve safety and client satisfaction levels

Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals

Audience Level: Basic

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Saturday, November 2, 2024, 8:00 AM – 5:00 PM

7. Engineering for the Biosafety Professional Part I

Biosafety professionals (BSOs) need to be involved and knowledgeable in the operation, maintenance, and certification of their biocontainment facilities and building systems. The BSO is called upon to participate in the planning, design, and validation of a new biocontainment laboratory or renovation of an existing facility. This course provides basic engineering principles that are useful in the planning, design, and operation of a BSL-3 facility and is intended to fill the gap by providing basic knowledge for understanding the processes used in the planning, design, construction, maintenance, and operation of a BSL-3 laboratory. For the BSO to participate in these activities, they need to understand engineering fundamentals, develop skills to ask questions in engineering terms, and possess the confidence to question the answers. This is the first course of a two-part series offered in alternating years. Part I of the course will provide information relevant to BSL-3 facilities for the determination of air change rates, define HVAC containment boundaries, interpret design drawings, understand HEPA filtration, provide an introduction to determining room heat loads and ventilation rates, provide concepts in directional airflow and room pressure differentials as well as an introduction to HVAC components. There will be presentations on planning, design (with a checklist), construction oversight, commissioning, certification/validation/ANSI Z9.14 Standard, maintenance, and operations. Upon course conclusion, the attendees should have the knowledge to better understand engineering issues in the planning, design, construction, commissioning, certification/validation, and post-occupancy of biocontainment facilities, be able to formulate informed questions, be able to interact with maintenance personnel and integrate facility operations with the biosafety program.

Objectives:

• Discuss engineering principles and the design and construction process of a BSL-3 laboratory
• Recall the phases and the strategies of a BSL-3 laboratory design
• Identify potential problems before construction begins
• Describe the elements of a quality assurance program

Suggested Background: None
Target Audience: All Biosafety Professionals, Operations and Maintenance Staff

Audience Level: Intermediate

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Saturday, November 2, 2024, 8:00 AM – 5:00 PM

8. Keeping it Going: Maintaining and Improving a Select Agent Program Over the Long Term

Keeping a select agent program going can be difficult, especially in the face of ever-changing regulatory requirements and limited resources. Established procedures may suddenly become unacceptable, interrupting research and frustrating laboratorians. Likewise, a single unexpected adverse event can put an entire program at risk. Being prepared to deal with such changes and events is critical to maintaining a robust program. Anticipating future challenges can be even more advantageous, elevating a program from good to great. A proactive approach can minimize the impact of new requirements and reduce duration and frequency of crises sparked by sudden, unexpected requirements or events. This course will explore strategies for maintaining and improving an existing program, including how to anticipate and respond to new requirements. The focus will be on U.S. select agent requirements, although a small section on comparable requirements in the international community will be included. Strategies will be based on the instructors’ experience with their program with additional input solicited from class attendees during open discussions. Topics will include select agent program history; effective oversight; efficiently meeting ongoing requirements; reporting, responding to, and analyzing incidents; suitability program case studies; inactivation requirements, including “failure” investigation; and inspection preparation and response. The course will consist of topical presentations followed by group discussions aimed at facilitating application of presented strategies to attendees’ individual programs and providing a platform to capitalize on attendees’ collective experience.

Objectives:

• Identify strategies for efficiently maintaining a select agent or equivalent program in good standing with ongoing requirements, including anticipating areas of emphasis in future inspections and/or future regulatory changes
• Indentify strategies for preparing for and responding to regulatory inspections, including strategies to efficiently implement necessary changes
• Review a series of suitability program case studies and identify strategies for dealing with potential suitability concerns
• Summarize inactivation requirements and identify successful strategies for compliance

Suggested Background: None
Target Audience: All Safety Professionals, Select Agent Program Safety Professionals

Audience Level: Intermediate

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Saturday, November 2, 2024, 8:00 AM – 5:00 PM

9. Fixing Broken Laboratories

Laboratory construction represents a small segment of the global construction industry, encompassing various types such as food and chemical laboratories. However, facilities that integrate biorisk considerations into their core design are relatively rare. Even scarcer are laboratories where biosafety and biosecurity design are critical for safe operation. The scarcity of such construction projects means that the skills and competencies required to deliver biorisk laboratories are equally uncommon. Typically, very few designers have experience designing even one facility, far less have significant experience designing multiple facilities. Those in the construction field change jobs often, so even companies with good historic experience cannot field the same team delivering successful projects in the past. Similarly, client-side laboratory construction experience may be lacking. New facilities are scarce. Those involved from client and user teams may have limited or no experience of how to interact with construction industry professionals to achieve a fully functional facility, fit for the needs and purpose intended. This lack of competence on one or both sides of a design team can lead to problems which only manifest themselves after a great deal of time and money has been invested, and can result in a range of problems. Such issues can persist and, in some cases, hinder or prevent the effective operation of the facility. This course aims to introduce the fundamentals of designing and constructing biosafety laboratories. Through case studies, the attendees will explore common problems in laboratory design and construction. Each case study will introduce problem solving and fault-finding techniques, including root cause and solutions. Suboptimally functioning laboratories are not uncommon, but with the right approach, most can be remediated. Attendees are expected to gain in confidence and learn structured fault-finding techniques that they can apply to address challenges in their own facility.

Objectives:

• Summarize the fundamentals of biosafety laboratory design
• Identify what structured fault-finding techniques are available to evaluate sub-optimal, failing or failed laboratories
• Apply techniques learned to real life experiential problems with sub-optimal, under-performing, failing or failed facilities

Suggested Background: Biosafety and Biosecurity Training Course (BBTC®), BSL-3 Operations and Management, Fundamentals of Biosafety, Principles and Practices of Biosafety® (PPB)
Target Audience: All Safety Professionals, Experienced Biosafety Professionals, Facility Managers and Laboratory Managers

Audience Level: Advanced

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Saturday, November 2, 2024, 8:00 AM – 12:00 PM

10. Introduction to Biosafety

This course is designed for individuals new to the profession, EHS professionals needing an understanding of biosafety, and for those interested in a refresher on the fundamental principles and practices of biosafety. Participants will gain a solid foundation in biosafety concepts, enabling them to understand and mitigate risks associated with biological materials in various laboratory settings. Class content and discussion include regulatory standards and guidelines, hazard identification, risk assessment and mitigation. Mitigations discussed will include biosafety levels and facility design, proper choice and use of personal protective equipment, waste management, decontamination and sterilization, and more.

Objectives:

• Identify the breadth of duties that may be central or peripheral to a biosafety professional
• Restate the major sources of regulatory and guidance materials available to them
• Describe the roles others within the institution play in supporting biosafety

Suggested Background: None
Target Audience: New Biosafety Professionals, Laboratory Workers

Audience Level: Basic

This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 3.5 P.A.C.E.^® contact hours.

Saturday, November 2, 2024, 8:00 AM – 12:00 PM

11. Integrating AI into Synthetic Biology: A Biosecurity Risk Assessment Course

This intensive half-day course is designed for biorisk management professionals who are at the forefront of integrating Artificial Intelligence (AI) into synthetic biology. With AI rapidly transforming scientific research and applications, its adoption presents unique biosecurity challenges. This course provides an in-depth look into the specialized biosecurity risk assessment process tailored for AI applications in synthetic biology, combining theoretical foundations with practical, hands-on exercises and interactive case studies. Some of the topics to be covered include: an overview of AI technologies and their applications in synthetic biology; fundamentals of biosecurity risk assessment for AI; discuss the concepts of vulnerability, threat, risk, consequence, and mitigation; develop a dynamic risk management plan and strategies for continuous monitoring and updating of risk assessments to address the evolving nature of AI technologies and synthetic biology applications. Attendees will also discuss the challenges of maintaining an adaptable and proactive risk management stance in a rapidly advancing scientific field.

Objectives:

• Explain at a basic level the AI integration in synthetic biology research
• Identify associated biosecurity risks
• Apply a structured approach to assess these risks using newly developed tools and methodologies

Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, All Biosafety Professionals

Audience Level: Basic

This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 3.5 P.A.C.E.^® contact hours.

Saturday, November 2, 2024, 1:00 pm – 5:00 pm

12. Respiratory Protection for Biosafety Professionals

This course will provide an overview of respiratory protection personal protection equipment (PPE), including selection considerations for biological and chemical hazards. A deeper dive into key hazards relevant to biosafety professionals and their respiratory protection considerations will follow. While mostly based on U.S. OSHA Respiratory Protection Program requirements, much of theinformation presented will be applicable internationally.

Objectives:

• Describe the basic process for hazard and exposure assessment necessary for selecting appropriate respiratory protection equipment
• Identify the types and styles of respiratory protection equipment, in addition to U.S. OSHA requirements for their use
• Summarize the process of respirator selection and product implementation in their workplace for key hazards

Suggested Background: None
Target Audience: All Biosafety Professionals, All Safety Professionals

Audience Level: Intermediate

This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 3.5 P.A.C.E.^® contact hours.

Saturday, November 2, 2024, 1:00 PM – 5:00 PM

13. Field Research Safety for Biosafety Professionals

Biosafety professionals are often tasked with reviewing field research protocols, but many biosafety professionals have never received training in field research safety. In this course, attendees will review hazards inherent to fieldwork, lessons learned from past incidents, and assess risk for a variety of field projects. The attendees will discuss safe work practices in the field and exposure control approaches for zoonotic, vector-borne, soil-borne, and water-borne diseases. The course will also assist attendees to identify potential gaps in institutional and regulatory oversight and steps to improve a culture of safety and preparedness in the field.

Objectives:

• Review common environmental hazards; zoonotic, vector-borne, soil-borne, and water-borne diseases relevant to outdoor or remote fieldwork
• Evaluate risk tolerance as it relates to protocol and research review
• Assess risk for a variety of field projects including wildlife research, community health studies, excavating soil, plant surveys, etc.
• Identify reasonable controls and expectations
• Describe the compliance drivers, model field safety programs, written field safety plan templates; as well as best practices, technical references and potential actions to improve culture of safety and preparedness in the field

Suggested Background: None
Target Audience: All Biosafety Professionals

Audience Level: Intermediate

This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 3.5 P.A.C.E.^® contact hours.

Sunday, November 3, 2024, 8:00 AM – 5:00 PM

14. Medical Emergencies in the Laboratory – Are you prepared?

Biological Sciences form the foundation of medical research and healthcare including: biochemistry, molecular, cellular, developmental biology, microbiology, plant biology/pathology and public health. Biosafety professionals regularly train staff to handle spills, exposure to chemicals, weather related events, power outages, and biosecurity, but what about medical emergencies? Your organization may have emergency response procedures, but are the individuals in the lab, field, or even visitors prepared to handle first aid in situations involving biologicals? Personnel should be able to recognize and react to medical emergencies they may encounter at your institution involving biologicals. Early recognition of potential medical emergencies can reduce long-term or deadly consequences and legal challenges. Medical emergencies may involve only one individual or it can be a large-scale emergency. Prepare your personnel to respond appropriately in order to avoid worsening the situation. Discover ways to improve communication and cooperation with internal emergency response teams and local emergency responders (911 operators, fire, EMS, law enforcement) when biologicals are involved. Consider the impact when First Responders arrive on scene and see a BSL-2 or BSL-3 sign. If an ambulance is required, is the patient ready to transport? Although you cannot predict every emergency, preparing your personnel to think through a response by preplanning for an event and the steps to recovery is necessary to simplify an emergency response. This class will offer guidance and assistance in preparing for emergencies.

Objectives:

• Establish relationships with local emergency response
• Summarize the right response in a medical emergency
• Communicate the decontamination procedures to employees and emergency responders

Suggested Background: Basic first aid
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers

Audience Level: Basic

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Sunday, November 3, 2024, 8:00 AM – 5:00 PM

15. Pharmaceutical Biosafety Officer Training

The course is intended for Pharma Biosafety Officers (BSOs), BSOs with interest in the biopharmaceutical industry, and can be a complimentary course to Principles and Practices of Biosafety® (PPB) offered by ABSA International. The instructors will review the Biosafety Regulatory Frameworks including key regulations in the U.S. and non-US regulations and key differences between regions. This includes an Introduction to the Biorisk Management Framework and the new ISO Standard. Key topics on Applied Biosafety, including examples of new technologies in industry (e.g., CRISPR, viral vector gene therapy, others), will be discussed as well as a review of the hazard classification of human cell lines, animal blood and tissue samples, a discussion on examples of LAIs (e.g., N. meningitis, rabies), improper inactivation scenarios, and environmental release of biological agents (including a biological agent release scenario—how to handle). Good Manufacturing Practices (GMP) will be discussed including what it is, why it is important, and how to harmonize GMP and biosafety requirements. This interactive course will feature a variety of group exercises where attendees will review engineering design requirements, P&IDs, identify issues, propose recommendations for what is acceptable vs. not, HVAC design, placement and type of equipment, room pressurization, workflow, decontamination (e.g., autoclave, HEPA, kill tanks), process equipment containment. A risk assessment course will be featured as part of the group exercises where attendees will discuss how to complete a risk assessment with certain perameters, then each groups risk assessment will run through an approval process (e.g., IBC) with other groups acting as the IBC and collectively review each other’s risk assessment. The course will conclude with roundtable discussions including the group scenarious, discussions, and further Q&A.

Objectives:

• Identify the global biorisk management regulatory frameworks as applicable to pharmaceutical companies
• Restate how to harmonize GMP and biosafety, and how to integrate biosafety principles into engineering design projects (including lab and large-scale)
• Summarize how to conduct a biorisk assessment and expectations for biosafety committee approval

Suggested Background: Fundamentals of Biosafety, Micro/Molecular Biology 101, Principles and Practices of Biosafety^® (PPB), Risk Assessment
Target Audience: All Biosafety Professionals

Audience Level: Intermediate

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Sunday, November 3, 2024, 8:00 AM – 5:00 PM

16. Commissioning and Recommissioning for BSL-3 Containment Laboratory

By understanding the commissioning and recommissioning processes, it can assist the biosafety professional in start-up or maintaining their laboratory operations to perform the program. Laboratory commissioning, identified in containment guidance documents, is a quality assurance process for the effective functioning of biocontainment laboratories. The biosafety officer and other decision makers benefit by having a basic understanding of the commissioning and recommissioning processes and resulting documentation. This course will review the phases of the new facility commissioning process and similar process for recommissioning. This knowledge base allows the biosafety professional to recognize how commissioning assists in providing and documenting a properly operating facility. A review of the secondary containment features of the BSL-3 laboratory will be disucssed and note specific issues typically observed. There will be a focus on two issues, the reversal of directional airflow and sealing of surfaces and penetrations. Participants will consider methods to identify the issues and present some specific mitigations of these issues; can actively participate in the commissioning/recommissioning processes and understand the methodology, the tools, results, and their interpretation; will know their facility operates correctly, its limitations, and the risk when it does not. This knowledge allows the biosafety professional to check or back check the containment spaces’ performance and use this knowledge to perform daily inspections for maintenance or replacement and control risk to the lowest level. The biosafety professional can identify required features in a new laboratory or review an existing lab with a better understanding of typical issues to assure safe reliable operations.

Objectives:

• Develop an understanding of the overall commissioning and recommissioning processes for containment labs
• Articulate the engineering controls required and effectively participate in the processes
• Identify typical issues observed during commissioning/recommissioning of the laboratory secondary containment barriers and the options for practical solutions to those issues
• Demonstrate a knowledge base and provide documentation to better perform daily inspections to reduce risk for safe and reliable laboratory operations

Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, Operations and Maintenance Personnel

Audience Level: Intermediate

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Sunday, November 3, 2024, 8:00 AM – 5:00 PM

17. Strategies for Designing and Implementing a Culture of Safety

As biosafety professionals, we all desire to foster a culture of safety and responsible conduct at our institutions. We often have a clear vision of how this culture should look and feel, but how do you move from the current organizational culture to the one you desire? This course will define organizational culture; understand how culture forms; and identify artifacts, espoused values, and shared beliefs that can be used to describe an organization’s culture. Attendees will use these definitions to identify attributes of their own organization’s culture that support or block a culture of safety and responsibility. Unfortunately, most change efforts in organizations fail. Changing existing culture is difficult and can take many years. However, several change management models can be employed to develop a roadmap for effecting change. Participants in this course will learn about the Lewin and Kotter change management models and their application. Participants will apply these models to case studies of organizational change to understand how they can be leveraged at their own organizations.

Objectives:

• Describe what organizational culture is, how to identify and define it, and how it forms
• Identify attributes of an organization’s culture that block or enable safety programs
• Apply change management models such as Lewin and Kotter models to effect organizational change

Suggested Background: None
Target Audience: All Safety Professionals, Experienced Biosafety Professionals

Audience Level: Intermediate

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Sunday, November 3, 2024, 8:00 AM – 5:00 PM

18. ISO 35001 Implementation Course

In 2019, ISO published a new biorisk management standard that many biomedical research laboratories all over the world are adopting. This course will provide presentations, facilitated discussions and tools to introduce concepts related to biosecurity and biosafety (biorisk) management systems. Participants will learn in-depth both the theory of biorisk management (BRM) systems and how to use the new laboratory biorisk management framework ISO 35001 as a planning tool to map their existing management system to the new standard and identify and prioritize opportunities to improve their existing system using the new ISO standard. Using the ISO 35001 as a planning and mapping tool will enable institutions to effectively identify, assess, control, and monitor the laboratory biosafety and biosecurity risks associated with hazardous biological materials using the concept of continual improvement through the PDCA (Plan-Do-Check-Act) principle.

Objectives:

• Identify the key elements of a BRM system based on the review sections of the ISO 35001 BRM system standard
• Map their existing BRM systems to the ISO 35001 and identify both strengths and opportunities to improve existing system
• Prioritize elements or areas that need improvement
• Select an area for improvement and identify a simple, short term, project idea to help strengthen one element within their existing system

Suggested Background: None
Target Audience: Experienced Biosafety Professionals, All Safety Professionals

Audience Level: Advanced

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.^® Program. This course is approved for 7.5 P.A.C.E.^® contact hours.

Sunday, November 3, 2024, 8:00 AM – 12:00 PM

19. The Big, Bright Beautiful World of BSL-2

In the world of biosafety, balancing risk management with potential uncertainties can be tricky. We have all heard the adage that in biosafety, “it depends”, and nowhere is this a more accurate statement than in a biosafety level 2 (BSL-2) laboratory. Unlike the clear-cut requirements of other containment levels, BSL-2 boasts a spectrum of flexibility that can be both empowering and confusing. Housing agents from Risk Group categories 1 through 3, BSL-2 laboratories can resemble the “wild west” of biosafety. While this adaptability allows tailored safety protocols, it also provides a breeding ground for uncertainty and potential for error. When does a BSL-1 space become a BSL-2 lab or BSL-2 become a BSL-3? Where do recommendations end and requirements begins? When can an RG-3 agent be handled in a BSL-2 laboratory, and why? From understanding airflow requirements and choosing the right biosafety cabinet (if you need it) to choosing crafting functional safety protocol and assessing the highly controversial BSL-2+, this course is intended for the biosafety novice to delve deeper into the ever fluid BSL-2 space and gain confidence navigating the waters where “it depends”.

Objectives:

• Distinguish between recommendations and requirements for BSL-2 laboratories
• Identify when RG-3 agents are handled under BSL-2 containment and when should RG-1 agents be moved to BSL-2
• Restate how to adjust the 3 risk mitigation controls to get to meet specific biosafety needs and what is “BSL-2+”

Suggested Background: None
Target Audience New Biosafety Professionals, Laboratory Workers, Clinicians, EHS, Other safety professionals who work with biological materials

Audience Level: Basic

This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 3.5 P.A.C.E.® contact hours.

Sunday, November 3, 2024, 8:00 AM – 12:00 PM

20. Implementing Field Biosafety Levels: Standardizing Safety Across Disciplines

The challenge of standardizing biosafety in field settings, especially in studies involving zoonotic disease transmission, has historically been complicated by inconsistent guidance from various institutional biosafety committees, Institutional Animal Care and Use Committees (IACUCs), and governmental agencies. This inconsistency often stems from differing levels of field experience and expertise among these groups. This course will address this gap by introducing a set of innovative Field Biosafety Levels (FBSLs) aimed at establishing uniform safety guidelines applicable to all researchers, regardless of their scientific discipline or the nature of their field work. This course will guide attendees through the critical processes of identifying primary hazards, conducting thorough risk assessments, and applying the novel FBSL framework effectively in their projects. By following a structured hierarchy of hazard controls, the FBSL framework provides the first comprehensive, risk-based guidelines designed to enhance health preparedness, enforce rigorous hygiene practices, ensure effective decontamination procedures, and manage waste efficiently. Additionally, the course will explore a tiered system of personal protective equipment (PPE) selection, tailored to varying levels of exposure and risk. Attendees will leave with a deeper understanding of how to integrate these standards into their fieldwork, resulting in improved safety outcomes and reduced risk of pathogen transmission. This course is crucial for researchers seeking to elevate the safety protocols of their field studies, providing them with the tools and knowledge to implement best practices consistently and effectively.

Objectives:

• Identify and apply FBSLs to effectively apply standards to various types of field research
• Apply techniques to conduct thorough risk assessments tailored to field settings
• Implement enhanced health and safety protocols

Suggested Background: Fundamentals of Biosafety, Principles and Practices of Biosafety® (PPB), Risk Assessment, Virology/Viral Vectors
Target Audience: All Safety Professionals, Scientists conducting activities in the field

Audience Level: Basic

This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 3.5 P.A.C.E.® contact hours.

Sunday, November 3, 2024, 1:00 PM – 5:00 PM

21. Lessons Learned to Improve Biosafety

Preventing laboratory-acquired infections (LAIs) is a challenge for laboratory managers and biosafety professionals, especially when dealing with an emerging pathogen. It is extremely important to quickly determine if there has been an exposure, how many may have been exposed, what steps need to happen next, including any prophylaxis, root cause analysis, gaps in the biosafety plan, and additional mitigation measures that need to be implemented. This interactive course will examine published papers from the ABSA LAI Database on laboratory acquired infections and exposures to determine what we can learn to prevent future exposures. Attendees will thoroughly examine the literature on the history of lab-acquired infections, review specific published articles, utilize the Association of Public Health Laboratories (APHL) ‘Laboratory Exposure Assessment and Symptom Monitoring Guide’ (exposure assessment tool) to assess exposures, analyze data to identify root causes of exposures, discuss identified gaps, and establish additional steps required to mitigate risks. Afterwards, attendees will divide into groups and receive new scenarios from the database. Using the APHL exposure assessment tool, they will apply the process demonstrated earlier—from determining exposure to conducting root cause analysis, identifying gaps, and proposing mitigation steps to prevent recurrence. Attendees will then learn to utilize published data on lab-acquired infections and these tools to safely handle emerging pathogens.

Objectives:

• Describe how the ABSA LAI database can be used for biosafety training and determining how to safely work with emerging pathogens
• Utilize the APHL exposure assessment tool to assess real-life laboratory incidents for potential exposures and to help guide prophylaxis if indicated
• Analyze actual laboratory incidents to determine the root cause and what steps are necessary to mitigate future incidents

Suggested Background: Fundamentals of Biosafety, Risk Assessment
Target Audience: All Safety Professionals, Laboratory Workers

Audience Level: Intermediate

This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 3.5 P.A.C.E.® contact hours.

Sunday, November 3, 2024, 1:00 PM – 5:00 PM

22. Navigating Regulatory Audits in Biosafety: Strategies for Success

In biosafety, regulatory compliance is paramount to ensure the safe handling of biological materials and maintain the integrity of research and healthcare activities. This course is designed to equip biosafety professionals, laboratory managers, and clinical research personnel with the knowledge and strategies to prepare for and successfully navigate regulatory audits. The course, filled with practical and applicable content, will cover critical regulatory frameworks relevant to biosafety, including those outlined by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Occupational Safety and Health Administration (OSHA). Attendees will gain insights into audit preparation techniques, documentation requirements, and best practices for ensuring compliance with regulatory standards. Through interactive discussions, case studies, and mock audit scenarios, attendees will learn how to identify potential audit pitfalls, address non-compliance issues, and implement corrective actions to strengthen their biosafety programs. Whether preparing for routine inspections or facing an unanticipated audit, this course will provide invaluable guidance and practical strategies to navigate regulatory audits confidently and successfully.

Objectives:

• Develop a comprehensive audit preparation plan incorporating documentation requirements outlined by regulatory agencies such as the CDC, NIH, and OSHA
• Demonstrate proficiency in identifying potential audit pitfalls and addressing non-compliance issues within a biosafety program
• Interpret audit findings and implement corrective actions to strengthen a biosafety program and improve regulatory compliance practices

Suggested Background: None
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Worker

Audience Level: Intermediate

This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 3.5 P.A.C.E.® contact hours.