CERTEK has the qualifications, experienced professionals and resources to design and manufacture your laboratory, test and commission its systems, develop SOP's and train client's staff. The personnel who conduct the facility verification do so as credentialed biosafety professionals:
- Registered Biosafety Professionals (RBP) OR
- Certified Biological Safety Professionals (CBSP), per ABSA International and the American Society for Microbiology
The facility and programs are verified against the following industry standards:
- Compliance against the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Ed.
- Compliance against the World Health Organization (WHO) Laboratory Biosafety Manual, 4th Ed.
- Compliance against the ISO 35001: Biorisk management for laboratories and other related organizations
- Compliance against the ISO 9001: A 5-stage inspection process for quality control and quality assurance
- Compliance against any additional geographic specific standards / guidelines
Upon successful facility and program evaluation, the lab facility can be granted a Verification of Biorisk Management Compliance Against International Guidance and Standards. This verification, in conjunction with other compliance documentation, will tell government and international organizations that credentialed evaluators have assessed and verified the facilities and programs against the guidance referenced above signaling that laboratory is both safe and secure to work in.
Meet the team of Operational Planning Specialists:
Mr. Baugh has been working in the construction of modular biological containment laboratory for 19 years, he has been directly involved with the design, construction, and commissioning of 28 biological safety laboratories including, BSL-3, ABSL-3, All Hazard Receipt Facilities, BSL-4 Cabinet Laboratories and mobile BSL-3 laboratories. Mr. Baugh is a retired Senior Non-Commissioned Officer and graduate of the United States Army Nuclear, Biological, and Chemical (NBC) Course Class #0390, where he has been training Soldiers and Airman in Establishment of NBC defense measures. He provided training advice and supervision regarding NBC equipment and operations, training of personnel on NBC response operations, preparation for NBC defense Actions and Procedures, and the wear and use of protective equipment. Mr. Baugh is also manufacturer trained in multiple decontamination processes and cycle development including Vaporized Hydrogen Peroxide and Chlorine Dioxide. Mr. Baugh also served as a Senior Custodial Agent in the Personnel Reliability Program that brings an in-depth knowledge of Special Weapons security. Mr. Baugh has worked as a senior instructor/writer for Airbase Ground Defense Operations including establishing a bare base security through base security operations.
Ryan Burnette, Ph.D., Director, Science & Technology, Merrick & Company
Dr. Burnette is an international biosecurity, biosafety, risk, and threat management practitioner having worked extensively in both North America and overseas markets. He has consulted on biocontainment, biosafety, and biosecurity programs and has built relationships with clients and stakeholders in over 100 universities, biopharmaceutical companies, and research institutes. To date, Dr. Burnette has worked extensively in the U.S., Southeast Asia, Africa, India, and the Caribbean on biosafety/biosecurity and laboratory capacity building, in conjunction with the U.S. Department of State, Centers for Disease Control and Prevention, Department of Defense, as well as many foreign ministries. Dr. Burnette currently serves as the Senior Project Manager on the National Bio- and Agro-Defense Facility (NBAF), Operational Planning and Technology Integration Contract (OPTIC). In this position, Dr. Burnette is responsible for all strategic development and execution of all multi-faceted project areas, including 1) the relocation of the biorepository from the Plum Island Animal Disease Center in New York to Manhattan, KS, 2) development of the strategic plan for Federal Select Agent Program registration, 3) overall BSL3, BSL4 laboratory operational planning (e.g., training, SOPs, significant regulatory programs), and 3) development and implementation of NBAF-wide IT systems. Dr. Burnette has worked on many other significant projects including: the assessment of the full biosafety program at Sanofi Pasteur, Poliovirus, Pertussis, Diphtheria Vaccine Production Facility against the CDC/NIH BMBL 5; the development of a Biorisk Management program through Centers for Disease Control and Prevention at the National Reference Laboratory for the Dominican Republic; and the design, verification, and laboratory operations and biosecurity program development for the Nyumbani Diagnostic Laboratory in Kenya. The Nyumbani Laboratory has since acquired WHO AFRO accreditation and ISO 15189 accreditation.
Bob Hawley, Ph.D., RBP, SM(NRCM), CBSP
Dr. Bob Hawley currently serves as an independent consultant in biological safety and security. Prior to working as a consultant, Dr. Hawley worked with and supported many of the leading companies and organizations in the industry. He previously served as the Principal scientist and Senior Advisor of Science at the Midwest Research Institute Global (MRI). During this time, he conducted biosafety threat analyses and risk assessments and provided recommendations for existing biological containment laboratories, new laboratories, veterinary facilities, and disease surveillance systems. Dr. Hawley has presented and authored journal articles and textbook chapters on many topics related to biosciences including, but not limited to: biological safety and security, biocontainment and decontamination, and bioterrorism and biowarfare. In addition, Dr. Hawley contributed as a coauthor to the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition.
Marian Downing, RBP, CBSP, SM (NRCM)
Marian Downing serves as an independent biosafety consultant with 10 years’ experience in national and international laboratory assessment, large scale production, biosafety training and hands-on training, program and procedure review, temporary on-site BSO replacement, and acting as an IBC community member. Ms. Downing has contributed to many important efforts through her time serving as a consultant as well as through her previous work history. For 20 years, Ms. Downing supported Abbott Laboratories at a technical level and serving as the Biosafety Officer. During her time at Abbott, she developed, implemented, and oversaw a comprehensive biosafety program for approximately 2000 employees and provided support worldwide in the area of biosafety for the Diagnostic Division. Ms. Downing’s biosafety consulting experience led her to contributing ongoing efforts with many institutions across the world including the Department of State Bioengagement Program in the Philippines, the Nyumbani Orphanage Laboratory in Kenya, and several universities and pharmaceutical companies in the United States. Ms. Downing has also been an active member of the American Biosafety Association since 1993.
Wendy Shell, CMIOSH
Ms. Shell is recognized as a health and safety professional of the highest standards and knowledge. Her experience in the high hazard industry includes responsibilities for ensuring compliance with numerous pieces of legislation. Her skills include the ability to analyze complex situations, sometimes in high pressure scenarios, and make robust decisions, with actions that can be justified to both the senior directors of the organization and also to the Regulator. Wendy also contributes to the improvement programs and developing techniques and processes that can be adopted across many different sectors. Ms. Shell currently serves as the Biorisk Officer at the Austrian Agency for Health and Food Safety (AGES) where she implements and maintains a Biorisk management system to ensure legal and regulatory compliance as well as evaluates procedural changes to be implemented through evidence and risk based assessments. Ms. Shell also spent a significant time working with the Animal and Plant Health Agency (APHA) in Weybridge. During this time, she provided comprehensive and consistent Biorisk management throughout APHA, ensuring legal and regulatory compliance in all areas. She also produced policies, standards, and guidance documents aligning the Biorisk management system to CWA15793 (CEN Workshop Agreement on Laboratory Biorisk Management) and trained employees on all matters related to biosafety and biosecurity. Ms. Shell served as the manager of the EU, OIR, and FAO Reference Laboratory for Avian Influenza and Newcastle Disease under APHA and was responsible for both technical and managerial efforts. Ms. Shell is an active member of the Institute of Safety in Technology and Research as well as many other international Biosafety Associations and Networks.
Mr. Karpela is a Certified Threat Management Professional, serving as a subject matter expert in the fields of threat assessment, threat management, and security since 1986. During this time, he has consulted and coached government organizations and corporations on five continents in the prevention of violent crime, security issues, conflict resolution and risk mitigation. He is a graduate of Finland’s Police University College with a 20-year career in the National Police. He has also trained with the U.S. Secret Service and the Federal Bureau of Investigation. Mr. Karpela’s vast experience with threat management is clearly demonstrated in cases where analysis is put into practice, how multi-disciplinary teams of professionals are coached and how to manage low to median and high-risk cases related to violent behavior. He has worked as an expert consultant for the European Council, the Centre for Security Studies, and many other key international organizations. Mr. Karpela’s threat assessment and management expertise has been applied to many different sectors, including biocontainment facilities and laboratory spaces.
Don Callihan, Ph.D.
Dr. Callihan is an experienced clinical microbiologist and biological safety officer with more than 30 years of industry experience. He previously served as a Biosecurity and Biosafety Program Analyst for AT-RISK International, LLC, WIRB-WCG Biosafety, and Alliance Biosciences. Dr. Callihan has extensive experience with in-vitro diagnostic device design and development—including Tuberculosis (TB) diagnostics—as well as Geographic Information Systems (GIS) application and laboratory capacity design in developing countries. He was Divisional Biosafety Officer for BD Diagnostics for 18 years while part of their Research and Development team. He was also Assistant Director of Bacteriology at the Animal Health Diagnostic Center (formerly New York State Veterinary Diagnostic Laboratory) at Cornell University. Dr. Callihan has managed high-containment (BSL-3) laboratory projects for private, academic and government institutions in the U.S, providing design guidance, facility commissioning, test battery SOP development and personnel training; including 6 years as a Select Agent Responsible Official. Dr. Callihan served as the Biosafety Officer for Becton Dickinson Diagnostics Systems where he was responsible for the oversight for compliance with CDC/NIH biosafety guidelines in three Biosafety Level 3 (BSL-3) containment laboratories (including TB and Select Agent Programs) and over 20 QC and R&D laboratories operated using BSL-2 work practices, safety equipment, and facilities. Dr. Callihan has also supported international projects. Of note, under the US Defense Threat Reduction Agency, he trained laboratory workers on the operation of laboratory equipment and assisted with the refurbishment of a mobile laboratory in Pakistan.
Lauren Richardson, DVM, MPH, DACVPM
Lauren Richardson, DVM, DACVPM has a background in veterinary medicine and public health. With experience in large and small animal clinical medicine, food safety and defense, and infectious disease, Dr. Richardson has supported projects in Africa, Central Asia, Europe, Middle East, and North America. Her current position includes technical subject matter advisory support, training, and management for domestic and international work focused on laboratory operational planning and health systems strengthening efforts. Dr. Richardson has supported technical efforts across the world including serving as the Project Lead under the Defense Threat Reduction Agency (DTRA), executing projects in AFRICOM and EUCOM. Under DTRA, Dr. Richardson also supported the execution of technical country assessments related to health operations and planning, biosafety, biosecurity, and health information technology. Dr. Richardson has also conducted trainings and spoken at conferences on biosafety and biosecurity, as it pertains to animal health facilities and high containment facilities.