Governance and Change Control according to GxP and GMP Requirements

MessageThis Webinar is over
Date Nov 15, 2018
Time (9 AM – 4 PM)
Cost 103500.00
Online
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP non-compliant changes occur. This Change Control training course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.

Learning Objectives:
  • Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records
  • Understand all the required components of a thorough Change Control record
  • Understand all the elements of effective Change Control management:
    • How to develop a cross-functional team to ensure proper evaluation, approval and implementation of proposed changes
    • Ensure changes do not negatively impact the business or established marketing authorization
    • How to incorporate a Quality risk based approach to evaluating proposed changes
    • Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
    • Understand what steps should be taken post implementation to confirm the objectives were achieved
Who Should Attend:
  • Quality Assurance Department Management and Staff
  • Documentation Department Management and Staff
  • Manufacturing Department Management and Staff
  • Records Managers
  • Document Control Management and Staff
  • Compliance Department Management and Staff
  • Medical Affairs Management and Staff
  • IT/Software Department Management and Staff
  • Clinical Management and Staff
  • Laboratory Management and Staff

 


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