Webinar ID:   FDB3082

4-Hours Virtual Seminar on Change Control According to GxP and GMP Requirements

  4 Hours

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. FDB3082

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

Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

Lecture 1: GxP/GMP Framework
– Roles, Expectations, and its Consequences for the Regulated Industries

Lecture 2: Information Governance
– Procedures, Implementation and Document Management Systems
– Social Media Management and Information Governance

Lecture 3: Change Control Procedure
– GxP/GMP and Change Control Procedure
– Change Control Procedure Steps and Document Control

Lecture 4: Change Control Procedure for Information Technology (IT) Systems
– IT Change Control Procedure Steps

Lecture 5: Data Security
– Data Security Implementation
– E-Discovery Preparedness

Lecture 6: Crisis Management
– Understanding and Preparedness

Lecture 7: Change Management and User Adoption
– Change Management Strategy
– User Adoption Strategy

  • 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