World BioHazTec and MRI Global are pleased to be partnering together with Biorisk Management International to host the first ever ISO 35001:2019 Lead Auditor Courses in the United States.
Gaithersburg, Maryland on September 8 – 12, 2025
Register For September 8 – 12, 2025 Course in Gaithersburg, Maryland
Instructor
Dr. Stefan Wagener
CEO and Co-Founder of
Biorisk Management International
Who should attend?
This course is ideal for professionals in biorisk management, safety, and compliance roles who wish to enhance their auditing and implementing ISO 35001 skills. Additionally, senior and executive management individuals interested in elevating biorisk management in their infectious disease institutions and laboratories, thereby significantly improving their national & international recognition and biorisk management performance, will greatly benefit from this course.
What you’ll learn
ISO 19011:2018 Guidelines for auditing management systems: To qualify as an ISO management system “Lead Auditor,” we will address how to effectively develop, manage, and improve audit programs, focusing on the key principles of auditing as outlined in ISO 19011:2018. This ISO guidance document covers essential information on audit program management, auditing principles and processes, and the qualification and evaluation of personnel involved in an ISO management system standard conformity assessment (audits).
In-Depth ISO 35001: Dive deep into the individual clauses and requirements of ISO 35001:2019. We will spend 3 ½ days working through the individual clauses, examining implementation strategies, auditing, and biorisk management principles and practices. Additionally, we will discuss management tools and resources available to those interested in implementing the 35001-based biorisk management system (BRMS) at their home institution.
By combining ISO 35001 and 19011, participants will gain unique insights into the process of auditing a BRMS.
Course Approach
Practical, Real-World Application: Engage in individual and group interactive exercises and role plays to apply your new knowledge to real-world scenarios. Throughout the course, assessments will help measure your learning and competence.
This course is not an introduction to laboratory biosafety/biosecurity. It is tailored to senior professionals, and the total number of participants is limited to meet our course quality standards for teaching and excellence.
Course Objectives
- Describe the application of the principles, procedures, and techniques of auditing based on ISO 19011
- Successfully establish an audit team and initiate and execute audit processes
- Effectively audit an ISO-based management system (35001)
- Demonstrate appropriate personal attributes
- Accurately assess an organization’s biorisk management system conformity based on a 3rdparty audit
- Create a leadership and commitment plan for a BRMS
- Create an integrated performance evaluation and improvement program for a BRMS
- Assist in the full or partial implementation of a BRMS at an institution
International Certification
Exemplar Global has assessed this course and qualified Biorisk Management International as an Exemplar Global “Recognized Training Provider (RTP)”. All successful course participants will receive a BRMI and Exemplar Global Certificate of Training.
Register For September 8 – 12, 2025 Course in Gaithersburg, Maryland
Convenient Location
Gaithersburg, Maryland
Located just a short drive from Washington, D.C., Gaithersburg, MD combines the charm of a suburban community with the convenience of proximity to major metropolitan amenities. Gaithersburg is a key hub for the biosafety industry, offering an ideal environment for innovation and growth. Gaithersburg is home to a thriving biotech and life sciences ecosystem, with numerous research institutions, biotech companies, and federal agencies in close proximity. The city’s strong infrastructure, access to top-tier talent, and proximity to major public health organizations such as the FDA and NIH make it a prime location for businesses in the biosafety and biomanufacturing sectors.
Tentative: Kansas City, Missouri
Known for its iconic jazz scene, world-class barbecue, and thriving arts and entertainment district, Kansas City, MO provides a dynamic lifestyle and rich cultural heritage. Kansas City is rapidly becoming a pivotal center for the biosafety industry, with its strategic location, thriving biotech sector, and growing innovation ecosystem. With proximity to the National Bio and Agro-Defense Facility (NBAF), Kansas State University’s Biosecurity Research Institute, and Kansas City Animal Health Corridor and a robust network of bioscience organizations, the city provides a collaborative environment for organizations focused on biosafety, biosecurity, and biomanufacturing. Kansas City’s central location offers convenient access to major markets across the U.S., while its affordable cost of living and strong workforce development programs make it an attractive destination for biotech companies and professionals.
We are currently gauging interest in offering a second session of our course from September 15–19, 2025 in Kansas City, Missouri. If you’re interested in attending, please complete the interest form. If there is sufficient interest, we will contact you with additional details.
Accommodations
The workshop will take place for five full days (Monday through Friday). It is recommended that you arrive on the Sunday prior to the workshop and depart on Saturday or later.
Blocks of hotel rooms will be reserved for attendees at a discounted rate. More information will be available regarding hotel accommodations soon!
Register For September 8 – 12, 2025 Course in Gaithersburg, Maryland
World BioHazTec is an Accredited Provider (AP) of the International Association for Continuing Education and Training (IACET). As an IACET Accredited Provider, World BioHazTec offers IACET CEUs for its learning events that comply with the ANSI/IACET Continuing Education and Training Information.
