Training Checklist for New Reviewers - Administrative Memorandum #A90-4

    May 18, 1990
    
    Administrative Memorandum A90-4
    
    Training Checklist for New Reviewers
  
    Purpose.  
    
    The purpose of this memorandum is to disseminate the ODE Training 
    Checklist for New Reviewers. The Checklist provides guidance on 
    the training that is expected to be provided to each new reviewer 
    who joins the ODE staff.
    
    Training Checklist.  
    
    Attached is a copy of the ODE Training Checklist for New 
    Reviewers.  Each Office and Division within ODE is to follow the 
    checklist to assure that opportunity for at least this minimum 
    training is provided to each new ODE reviewer. Through this 
    training program and the ODE Mentor Program we can assure that 
    each new reviewer will become a productive and integrated member 
    of the ODE staff.  Problems encountered in implementing this 
    training for any particular reviewer should be brought to the 
    attention of Ms. Appler.
    
    Effective Date.  
    
    This program is effective immediately.
    
    
    Attachment
        

                                                     ATTACHMENT
    
    
    TRAINING CHECKLIST FOR NEW REVIEWERS - OFFICE OF DEVICE EVALUATION
    
    1.  Priority Focus for Initial Training
       (To be completed within first few years of employment)
         a.  ODE Orientation Program - 2 hours introduction to the 
             mission, organizational structure, responsibilities, 
             goals and philosophy of the Office
    
         b.  CDRH Orientation Program - 1 1/2 day program on FDA and 
             CDRH mission, organizational structure, etc.
    
         c.  New Reviewer Training - 2 day course conducted in-house
    
             1)  Responsibilities and Procedures in the Regulatory 
                 Process- 510(k)s, PMAs and IDEs: What they are and 
                 how they are used,including detailed information on 
                 processing from initial receipt to final disposition 
                 (including a typical example and some form of 
                 guidance manual)                     
    
             2)  Freedom of Information (FOI) Policies and Procedures-
                 confidentiality and proprietary information 
                 management
    
             3)  Medical Device Reporting (MDR) - access and 
                 applications; as well as orientation to Good 
                 Manufacturing Practices (GMPs), misbranding, 
                 adulteration and Good Laboratory Practices (GLPs)

             4)  How to Deal with Manufacturers - the relationship 
                 between the regulated industry and the regulating 
                 agency
    
             5)  Advisory Panels - their role and responsibilities, 
                 including their management
    
         d.  Basic Food and Drug Law Course or Medical Devices Law
             Workshop
    
         e.  FDA Ethics Awareness/Conflict of Interest Course
    
         f.  ADP Training - including word processor training (such as 
             Word Perfect or All-in-One), use of Electronic Messaging, 
             electronic bulletin boards, and specific software used at 
             the work place

    2.  Other Recommended Training
    
         a.  Technical Writing
    
         b.  Statistics or Biostatistics - refresher course
    
         c.  Clinical Study Design - refresher course
    
         d.  Technical Training or Refresher in Specific Area(s) - 
             such as lasers, ultrasound, software engineering, 
             statistics, etc. [possibly given in-house by our expert 
             reviewers]
    
         e.  Periodic Question and Answer Sessions with POS Staff - 
             possibly monthly or quarterly to provide for interchange 
             and update
    
         f.  Course in Interpersonal Relations and Teamwork

         g.  Professional Society or Association Annual Meeting - 
             relevant to the Division/Branch area(s) of scientific or 
             technical responsibility
    
         h.  Scientific Discipline-specific Seminar(s) or Workshop(s) 
             with a regulatory perspective
    
         i.  Field Visits and/or Inspections to Manufacturing Sites