Change Control According to GxP and GMP Requirements

Pharmaceutical and medical device companies are required by regulatory agencies to have a systematic approach especially when it comes to managing all changes made to a facility, the product or the quality system. Change is inevitable; however, it is essential that companies have a compliant and effective change control program. This will ensure that no unnecessary or non-compliant cGMP changes occur. This Change Control training session will discuss FDA, EU and ICH regulatory expectations. All the necessary components of a systematic Change Control program in accordance to Gxp and GMP requirements will be reviewed in detail. We will also discuss the elements to successful management an effective Change Control system

Learning Objectives:

• Learn to interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records
• Interpret 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
• Learn to incorporate a Quality risk based approach to evaluate 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

Seminar Agenda:

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

 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

Course Director: 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.