During FY 2003, we provided CDRH employees with extensive training opportunities, including: in-depth training on scientific and technical issues; CDRH programs and policy; the use of plain language in all CDRH communications; and training in communication, interpersonal and professional development skills. This training was presented in a variety of settings and formats:
- Over 177 different courses were presented for more than 2,800 “students.”4 Depending upon the topic and training objectives, individual courses can require a commitment of four to forty hours. The longer courses may spread over a period of several weeks.
- Thirty-four satellite teleconferences were offered and attended by over 330 CDRH employees.
- We continued to utilize CenterNet Live. This uses webcast technology to bring important seminars, lectures and presentations to every desktop computer in CDRH. Webcasting provides every CDRH employee with the flexibility to participate in important events “live” or at a later date through our playback schedule.
- CDRH increased the number of on-line course offerings to over 600 from SkillSoft Corporation’s Critical Skills Library. This program has been a great success and is frequently used as pre-assigned reading for many of our courses.
We introduced the Continuing Science Education Program at the end of FY 2003. This program is designed to encourage continual learning and to provide eligible employees with the opportunity to enhance their overall scientific knowledge and the unique integration of science and regulatory affairs.
The Continuing Science Education Program has two separate components that are based on academic partnerships with local institutions of higher learning. Both programs require 30 academic credit hours over a 2 year time period.
- The Science Education Leadership Program (SLEP) is offered for managers. It is presented in collaboration with Georgetown University and Virginia Polytechnic Institute. The curriculum consists of a compilation of courses focused on clinical science, device science and science management and policy. Specific courses include: Ethical Issues in Scientific Research; Risk Assessment; Biomaterials; New Product Development and Management; and, Applied Biostatistics.
- The Basic Science Education Program (BSEP) is offered for non-managers in collaboration with Montgomery College. The curriculum includes basic science courses in biology, anatomy and physiology, genetics, biotechnology, and medical terminology.
Course highlights during FY 2003 include:
- Core Competencies for CDRHStaffCollege: This program is under development with a contractor. Draft core competencies have been identified based on information from focus groups and surveys. A draft model of competencies has been developed and will be validated Center-wide.
- CDRH Leadership Forum: This program introduces a new series of speakers and workshops to the Center. The forum provides leadership training opportunities to all CDRH Managers with supervisory responsibilities. It is a series of five leadership topics and includes a mix of half day lectures and full day workshops. A live satellite broadcast was also included. Each topic in the forum addresses one or more core competencies as outlined in the CDRH Managerial Core Competencies and Learning Pathways Program.
- Mentoring for New Managers: This one-year pilot was administered in FY 2003. The participants in the program and their supervisors have submitted evaluations based upon their experiences. The pilot program was initiated from the CDRH Strategic Plan within the Magnet for Excellence Goal. It was considered a way to develop a skilled and talented pool of managers while ensuring continuity of knowledge and skills base. The value of the program is under review and results from the evaluations will determine the future of the program.
- Meet the Experts Seminar Series: This program includes targeted Science Seminars to provide an opportunity for CDRH staff to interact with nationally recognized experts. The seminars with external experts enable staff to stay abreast of recent discoveries with the added benefit of accelerating product reviews. Cardiovascular research was the first area targeted. The speakers highlighted their perspective on new developments and progress in the treatment of circulatory disease and the role of emerging technology reviewed by CDRH. Neurology was the second area targeted.
- Anatomy and Physiology: This eight week course was offered to CDRH employees with or without formal biological/medical training and provided a comprehensive overview of human anatomy and physiology.
- Basic Industrial Sterilization of Medical Devices: Thisten week course covered technologies used for industrial sterilization of medical devices and validation of sterilization processes. The course provides participants with a basic understanding of the principles of sterilization, the various methods of industrial sterilization, sterilization validation, and other activities associated with sterilization.
- Principles of Medical Device Measurements and Electronic Instrumentation: This nine week course addresses the basic principles in the area of medical device measurements and electronic instrumentation. It is offered to CDRH regulatory review and laboratory scientists/engineers, other than electrical engineers, who want to enhance or refresh their skills in this area.
- CDRH Clinical Trials: This course offers a comprehensive perspective on the use of clinical trials in the development of medical devices. It provides attendees with a working knowledge of regulatory, clinical and statistical issues of trial design. Lecturers included speakers from CDRH, other FDA offices, academia, and industry. This provided the broadest perspective possible on the challenges and practical real-life applications for both regulators and manufacturers.
- Emergency Preparedness: This course was offered to members of the CDRH Emergency and Disaster Teams. It covered member’s roles and responsibilities, provided descriptions of each of the four (4) triage categories, and familiarized members of the teams with the emergency/disaster checklists.
- Strokes: Pathology, Physiology, Imaging, Therapy and Treatment: This was a course that provided participants with an introduction to neuroanatomy and pathophysiology. This includes the functional areas of the brain, arterial supply and venous drainage, and a description of the pathology underlying stroke and transient ischemia. It also included an introduction to modern neuroradiology, including the basic concepts behind computed tomography (CT) and magnetic resonance imaging (MRI), and described how each is employed in diagnosing and quantifying stroke.
- Case Studies in Managing the CDRH Program: This courseis for CDRH managers, team leaders, and senior professionals who have major roles in managing Center programs or regulatory issues. It provides managers and senior professionals who tackle recurring and new Center programs/issues with the advantage of the perspectives and experiences of senior Center employees who have already faced these issues.
4There were approximately 1,050 CDRH employees in FY2003. Individual employees take advantage of several training opportunities during the year. Therefore, the number of “students” or “attendees” is greater than the number of employees.