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Regulatory Submissions, Information, and Document Management Forum


Session 8 Track 1: Processes - Don’t Make Them an Afterthought

    Session Chair(s)
      Sarah  Powell, RAC

      Sarah Powell, RAC

      • President
      • Powell Regulatory Services, United States
    Organizations often ignore one of the most critical success factors when implementing new technology – process definition. Learn how other organizations have approached process definition as an aid to successful implementations and change management.
    Learning Objective : Upon completion of this session, the participant should be able to:
    • Discuss importance of well-defined regulatory processes and the impact on your company's RIM success.
    • Share examples of methodology used by other organizations to effectively design processes in support of their RIM program
    Speaker(s)
      Elizabeth M Turek

      Importance of Well-Defined and Documented Processes to Your RIM Program

      Elizabeth M Turek

      • Senior Director, Global Regulatory Operations
      • Johnson & Johnson, United States
      Sarah  Powell, RAC

      Successful Process Definition Methodology

      Sarah Powell, RAC

      • President
      • Powell Regulatory Services, United States
      Representative Invited

      Case Study: Using Process Definition to Aid in Implementation of IDMP

      Representative Invited

      • United States