Daniel C. Coyle
email: dancoyle@cvbllcusa.com
Summary of Qualifications
Dan Coyle retired in October 2022 from the Center for Veterinary Biologics (CVB) as the Compliance Section Leader with 36 years of experience in veterinary biologics. Dan started his career developing and licensing vaccines for swine mucosal diseases. His 12 years of industry experience included quality control, vaccine development, scale up manufacturing, animal disease modeling, and manufacturing.
Dan joined CVB in October of 1998 where he started as a Biologics Specialist in the Inspection and Compliance Unit where he had oversight of several different types of veterinary manufacturing firms; performing inspections, educating firms, and serial release activities. He held several different positions simultaneously, including CVB Information Systems Security Officer, and the National Centers for Animal Health Security Manager. He has also been Section Leader for the Program Information Management and Security Section.
In 2006 Dan became the Compliance Section Leader, overseeing compliance and pharmacovigilance activities at the CVB. He has spent over 24 years inspecting both domestic and international veterinary biological firms. He has extensive experience in developing and implementing programs to ensure veterinary biologics are prepared and distributed in compliance with the Virus-Serum-Toxin Act and the requirements of Title 9 Code for Federal Regulations Parts 101-118. Dan developed policy in USDA GMP, electronic record requirements, separate and apart facility designation, analyzing investigations to manufacturing deviations, and advertising compliance.
Employment History:
Center for Veterinary Biologics
Section Leader, Compliance
July 2006 - October 2022
- Management of all Compliance activities and regulatory actions.
- Expert knowledge of acceptable facility construction, manufacturing processes, quality management and control, separate and apart designations, and biological production equipment to evaluate compliance with veterinary biologics regulations.
- Expert knowledge of USDA Good Manufacturing Procedures.
- Expert knowledge of recent developments in the specialty fields of biotechnology, virology, bacteriology, immunology, and epidemiology for evaluation of biological products and establishments and compliance with the regulations regarding the production, testing, and use of veterinary biologics.
- Expert knowledge of the laws, rules, regulations, and Agency policies involved in maintaining compliance with the Virus-Serum-Toxin Act (VSTA).
- Expert knowledge of Agency policies and procedures to oversee, coordinate and evaluate investigations concerning suspected violations of VSTA.
- Experience with national and international disease situations to evaluate and coordinate the role of the biologics program as it relates to the animal health industry and disease eradication.
- Supervisory Microbiologist, supervising 10 employees.
Center for Veterinary Biologics
Section Leader, Compliance and Acting National Centers for Animal Health (NCAH) Security Manager
August 2009 - July 2011
- Experience with USDA and APHIS Physical Security.
- Established, documents, and monitors cyber security program plan, and ensures compliance with management policies.
- Overall management for implementing and monitoring security policy and procedures intended to safeguard the physical security of employees at the NCAH; preventing unauthorized access to equipment, facilities, and material; safeguarding property from damage and theft; conducting, leading or participating in Security Risk Assessments, Physical Security Systems (access control, intrusion detection, video and intercom) Surveys, Inspections and Evaluations to ensure security systems are in place, adequate and functional.
- Developed policies on inventory control, bio-incident response, physical, biological and cyber security of NCAH facilities.
- Management of the NCAH Campus integrated access control and security system.
- Security force contractor management.
- Coordinated with Federal, State, and local law enforcement agencies on security matters to ensure adequate response by the appropriate agency and timely threat information.
- Managed development of business requirements and process flow for electronic record keeping and interface with regulated industry.
USDA Top Secret Security Clearance
2003 - October 2022 (retired)
- Select Agents and Toxins
- US Customs and Border Protection
- Other
Center for Veterinary Biologics
Section Leader, Program Information, Management and Security and CVB Information System Security Officer
August 2003 - July 2006
- CVB Program Liaison that works with the Information Management Staff to manage and secure both paper and electronic program information.
- Ensured program documentation is in compliance with APHIS regulations and directives for security, integrity, authenticity, and management/archival of documents related to the enforcement of the VSTA.
- Served as a liaison between Information Technology staff, CVB staff, and CVB licensed establishments to coordinate acquisition, implementation, maintenance, enhancement, and deployment of existing, acquired or newly developed technology used for the management and security of data from licensed manufacturing establishments and the CVB.
- Acted as a subject matter expert for the maintenance and development of computerized systems, services and applications used by the CVB for the implementation and enforcement of the VSTA.
- Responsible for determining the effect of new technologies of data management and implementation of appropriate technologies on the veterinary biologics program, its stakeholders, and customers.
- Reviewed and processed Freedom of Information Act (FOIA) requests submitted for CVB program records.
- Advised the CVB Directors in matters involving administration, resources, security, strategic planning & program initiatives from a records and data management perspective.
Center for Veterinary Biologics
Information System Security Officer
November 2003 - November 2008
- Advised the application system owners regarding policies and safeguards to ensure appropriate levels of information confidentiality, integrity, and availability.
- Assisted the application system owner with risk assessments and development of appropriate security controls and plans. Provide security plan to the organization ISSM at annually, along with other needed written reports as needed.
- Ensured that each system was properly certified and accredited for operation.
- Advised users and application developers about data sensitivity issues.
- Ensured that employee access to sensitive data was limited to only processes and resources necessary to accomplish assigned tasks, and to provide proper operational control of the flow of sensitive data through the organization.
- Participated in the development of security requirements during the acquisition of hardware, software, and services throughout life cycle of the assigned systems.
- Periodically reviewed the status of the systems to assure that changes haven't occurred that negatively affect security.
- Tested or monitored systems for vulnerability of security safeguards. Investigated and reported suspected security incidents.
Center for Veterinary Biologics
Biologics Specialist/Senior Biologics Specialist
October 1998 - August 2003
- Experience and knowledge of the production process of biological products including development, preparation, testing, handling, distribution and marketing in order to investigate suspected violations of the VSTA.
- Experience and knowledge of the VSTA in order to enforce its provisions and investigate suspected violations.
- Experience and knowledge of acceptable facility construction, work process arrangement and biological production equipment in order to evaluate firm compliance with regulations.
- Experience and knowledge of related fields of science (husbandry, veterinary medicine, biometrics, chemistry, physics, genetics, botany, and agronomy) in order to analyze production methods and testing procedures of biologics firms.
- Experience and knowledge of marketing and disease control practices of livestock industry (including cattle, swine, poultry, fish, pets, and exotic animals).
Saint's Brewing Company
Owner & President
July 1997 - July 2001
- Supervision of 30 full and part-time employees.
- Responsible for Purchasing & Sales.
- Manufacturing and distribution of products.
- Sales of products over $400,000 per year.
Ambico Inc. / Intervet Inc.
Bacterial Research Manager & Supervisor of Animal Care
September 1985 - July 1997
- Development and licensure of veterinary biological products.
- Product Development Project Manager.
- Compliance to Animal Welfare Act.
- Development of Outlines and Special Outlines of Production as well as manufacturing standard operating procedures.
- Developed infectious disease and vaccination models in large or small animals. Performed pathological necropsies including isolation and identification of disease.
- Development of Standard Operating Procedures.
- Use of pilot and industrial size fermenters.
- Development of quality control tests of veterinary biological products.
- Tissue culture techniques and experience with several different cell lines.
Education:
Drake University Des Moines, IA United States
Master's Degree June 1990
Major: Biology
Thesis: Investigation of Various Proteinase Treated Serpulina (Treponema) hyodysenteriae Vaccines.
Iowa State University Ames, IA United States
Bachelor's Degree June1985
Major: Microbiology Minor: Chemistry