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Regulatory Submissions, Information, and Document Management Forum


Session 5 Track 1: Registration Management

Session Chair(s)

Sarah  Powell, RAC

Sarah Powell, RAC

  • President
  • Powell Regulatory Services, United States
Registration Management in Medical Device organizations creates challenges that are different than those in a traditional pharmaceutical company. This session will focus on those challenges and solutions that can be applied.
Learning Objective : Describe the execution of aligning design controls process and business process management while adhering to medical device industry regulatory requirements. Discuss best practices for and limitations associated with the alignment of these processes for successful entrance of finished product into market.

Speaker(s)

Karin  Sailor

ID of Medical Devices in Registration Management Systems

Karin Sailor

  • Consultant
  • SRO, Inc, United States
Lana Jokhan Holder, MS

Regulatory Information Management System A Strategic Asset

Lana Jokhan Holder, MS

  • Sr. Project Manager
  • Life Sciences Solutions Transperfect, United States
Kanchana  Iyer, MS

Innovative Approach to Aligning Two Disparate Processes Within a Challenging Regulatory Framework

Kanchana Iyer, MS

  • Senior Regulatory Affairs Specialist
  • PENTAX Medical, United States