Change Control Processes

Description

Change Control Processes: Regulations & Compliance Training.

Change Control Processes are crucial for protecting patient safety and ensuring medicinal products meet specifications and quality, safety, and efficacy standards. This Change Control Processes e-learning course aims to equip you with the knowledge and tools to effectively implement change control processes in line with GMP standards.

Change Control Processes – Learning Objectives:

This Change Control Processes certificate GMP training course will enhance learners’ ability to:

1. Understand Change Control Procedures in GMP environments: Gain insight into the structured processes for managing changes within a GMP-regulated environment.
2. Comply with Regulatory Requirements: Familiarise themselves with the expectations of Regulatory Authorities and PIC/S GMP Guides.
3. Apply Best Practices: Develop the skills needed to ensure that Change Control documentation, risk assessments and post-implementation reviews are thorough, compliant, and efficient.

GMP Training Outcomes:

By reviewing key aspects of GMP compliance, learners will be able to:

• Understand the importance of following organisational Change Control processes.
• Follow established Change Control procedures with confidence.
• Navigate and interpret regulatory requirements for pharmaceutical industry change control procedures and processes.
• Conduct effective reviews to ensure compliance and minimise risks associated with changes.

This course will help your organisation learn to adhere to organisational change control procedures as part of GMP compliance, enhancing product quality, ensuring regulatory compliance, and fostering a culture of accountability and continuous improvement.

This course will help you and/or your team members to:

• Understand the importance of change control in GMP
• Identify key regulatory requirements for change control
• Outline the steps in the change control process
• Understand GMP requirements for assessing the impact of proposed changes
• Document change control procedures effectively and thoroughly
• Apply best practices for managing changes in pharmaceuticals
• Avoid common errors in the change control process
• Collaborate effectively across departments during change implementation
• Monitor and verify changes after implementation
• Recognise the risks of non-compliance in change control

The GMP eLearning course includes regulatory guidance examples on change control processes, such as PIC/S Guidance, the US FDA 21 CFRs Part 210 & Part 211, the Australian TGA, and the EU EMA including the European Commission’s ‘variations regulation’.

• One learner per licence.
• 24/7 access for 1 year from date of purpose (internet access required).
• GMP Training Certificate of Completion for personnel GMP Training Records will be available upon the Learner’s successful completion of the Final Assessment (built into the online GMP eLearning course).

Other relevant GMP eLearning courses include Managing Deviations & Non-Conformities and GMP requirements for CAPA.