Governance and Change Control according to GxP and GMP Requirements

Date	Nov 15, 2018
Time	12:00 AM EDT
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