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FY 2001 OHIP Annual Report - CDRH Staff College

OHIP provides all CDRH employees with comprehensive professional and technical training through our Staff College. Our products include classroom training, live satellite teleconferences, webcasts, online coursework, and a variety of seminars and lectures.

Goals

  1. To partner with all CDRH Offices in offering high quality, practical training solutions that meet CDRH's evolving needs and priorities.
  2. To provide individual employees with management, professional development and scientific/technical training opportunities that enhance their job performance and maximize their career potential.

Training Highlights

During FY2001, 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 (see next page for examples). This training was presented in a variety of settings and formats:
  • Over 100 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 from four to forty hours. The longer courses may spread over a period of several weeks.

Examples of FY2000 Training for CDRH Staff

  • Home/Self Care Technology: This one-day course addressed home/self care devices; one of the most important emerging technologies/trends identified in the Future Trends Study.
  • Risk Management: This comprehensive course in Risk Management for CDRH Staff also address HACCP principles. Internal, industry and academic faculty delivered the course.
  • Epidemiology: In conjunction with OSB’s Epidemiology staff, a new, semester-long course in Epidemiology was offered Fall 2000.
  • Anatomy and Physiology: This 8-week course was held for the first time in FY’01 and provided staff with a comprehensive overview of human anatomy and physiology.
  • Human Factors: In partnership with OHIP/DDUPSA, this course was developed as a refresher course in Human Factors.
  • Biocompatibility Case Studies: We continued to offer quarterly updates to the previously held 12-week course on biocompatibility, which was presented in Spring 2000. The updates give reviewers the opportunity to apply and reinforce knowledge gained about specific biocompatibility testing in the review and evaluation of medical device submissions.
  • Surfaces in Biomaterials: As a precursor in Biomaterials course scheduled for FY’02, the annual Surfaces in Biomaterials foundation Hemocompatible Surfaces Workshop was broadcast to CDFH employees via videoconferencing in August 2001.
  • Designing Cardiovascular Devices: Science Technology and Applications was offered for the first time in June 2001.
  • FOIA & Privacy Act Briefing updated participants with knowledge and understanding of the FOIA and Privacy Acts.
  • Plain Language/Technical Writing: A total of 114 employees attended our FY01 offerings. Three sessions were offered of a new course on Reviewing and Editing the Writing of Others for a total of 88 employees.
  • SkillSoft Training: a web-based, self-directed learning program with over 400 online courses was launched Center-wide in FY01.
  • OHIP offered an extensive program of over 100 video playbacks of recently recorded training and educational programs. The CDRH Learning Channel now has programming continuously available.
  • Pathways Program for Administrative & Support Staff: We continued to administer and market this program, which recognized its first Graduate in Spring 2001. The following courses were offered specifically for the Pathways program: Achieving Professional Goals Together, Teaming Up for Success, and Managing Support Staff.
  • Fifty-six high quality, seminars were held in FY2001. Over 1,700 employees attended these seminars. "Staff Updates" are scheduled on a flexible basis to address current or upcoming issues. "Science Grand Rounds" are held monthly to keep CDRH staff up-to-date on the latest medical device and radiation issues. This year, we added 5 Radiological Seminars and 1 Law Seminar Series. The speakers at our seminars are national and international experts from FDA, other government agencies, universities, and from the medical device industry.
  • Staff College continued to evaluate the impact of training on job performance. During FY01, impact surveys were conducted on several courses. The survey results indicate that classroom learning is applied to Center work products.
  • We continued to expand science-related satellite and audio teleconference offerings. Sixteen satellite teleconferences were offered and attended by over 300 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 maintained availability of offerings 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.

360° Training Program

The Staff College Training team continues to implement a "360 degree Training Program" in CDRH. The program has ensured that courses are more rigorously designed, developed, delivered, and assessed to ensure their quality and relevance to program goals. During FY’01, the training team continued to focus on needs assessment, training impact assessment, training transfer, evaluation, Staff College performance/evaluation measurement criteria, and benchmarking.

Electronic Course Evaluations

The pilot of electronic course evaluations conducted in FY’01 has been extremely successful with positive feedback from respondents throughout CDRH, as well as improved productivity of Staff College employees. OHIP will continue to conduct online course evaluations, impact surveys, and needs assessments and explore new ways to make use of this technology to improve the efficiency of CDRH training operations. _______________
4There were approximately 1,050 CDRH employees in FY2001. 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.

CDRH Manager Core Competencies and Learning Pathways

During FY’01, OHIP’s Staff College played a lead role in addressing the Center’s Strategic goal of becoming a Magnet for Excellence. Reaching this goal involves a proposal of developing and establishing core competencies and learning pathways for CDRH managers. The Magnet for Excellence Goal Group and nominated supervisors from throughout the Center continue to work on the development of this project. The project involves identifying the core competencies applicable to CDRH managers – basic knowledge and management/supervisory skills needed to excel and make CDRH a "magnet for excellence." The group will also develop "learning pathways" (a suggested core curriculum of courses) that build the knowledge and skills needed to address those competencies.

CDRH Mentoring Program

During FY’01, OHIP’s Staff College lead the Magnet for Excellence project plan proposal of developing a formally structured mentoring program for new supervisors. A subgroup of the Magnet for Excellence Goal Group, along with nominated employees throughout the Center, engaged in work to develop this project with guidance from an external consultant. The program will help develop a skilled and talented pool of employees whose competencies align with the CDRH strategic mission.

Workplace Assessment

In FY’01, in conjunction with a subgroup of the Magnet for Excellence Goal Group, OHIP’s Staff College assisted with the logistical aspects for an external consultant to conduct a workplace assessment survey to be conducted during FY’02. When the survey is completed, CDRH managers will receive feedback on survey results about their effectiveness in helping to build and to retain a strong workforce. OHIP will continue to assist the external consultant with coordinating workshops for managers as a follow-up to the FY’02 survey results.
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