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 GMP e-learning course aims to equip you with the knowledge and tools to effectively implement change control processes in line with GMP standards.

Key Learning Topics

Change Control Processes Training :

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

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

Essentials of Change Control (Importance):

By reviewing key aspects of change control requirements in regulated environments, 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 the pharmaceutical industry/GMP 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

This training will help participants understand regulatory requirements in the context of GMP compliance frameworks.\

Who Should Complete this Course?

Change control training course is suitable for a wide range of industry professionals, including:

✅ Quality Assurance & Quality Control Personnel
✅ Manufacturing & Production Personnel
✅ Operations & Product Line Managers
✅ IT Managers & Computer System Validation Professionals
✅ Facility Employees Involved in GMP Processes or Recordkeeping
✅ Research & Development (R&D) Teams
✅ Technical & SOP Writers for Change Control Processes
✅ Regulatory Affairs & Compliance Specialists
✅ Supply Chain & Logistics Managers
✅ Warehouse & Distribution Personnel
✅ GMP Auditors & Site Inspectors
✅ Regulatory Authority Representatives
✅ GMP Contractors
✅ Medical Device & Pharmaceutical Industry Personnel

Flexible Online Learning Format

This self-paced GMP eLearning course allows participants to:
✔️ Access course materials anytime, anywhere (valid for 12 months from the date of purchase)
✔️ Learn at their own pace with real-world Case Studies & Chang Control warning letter examples
✔️ Combine online learning with instructor-led training options (virtual or onsite, where available)

Change Control Processes: Training Certificate

Upon successful completion of this course, learners will receive a [Course title] (GMP) Training Certificate of Completion. This Certificate can be used to demonstrate GMP compliance training and attached to your personnel training records, promotion applications, your CV when applying for jobs, and other GMP industry records.

The GMP training course certificate demonstrates an individual has completed training in:

• Regulations covering requirements for change control processes.
• Best practices for change control systems.

Resources for GMP Training

It is recommended to review relevant GMP regulations and standards both before and after completing the course.

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 Certificate of Completion for this course will be available to download and print upon successful completion of the Final Assessment which is embedded into this course.

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