Overview:
The idea of change management is addressed throughout the cGMP regulations, such as when encountering issues and focusing on process improvements with the design of the manufacturing facility (§ 211.42), the design of the manufacturing equipment (§ 211.63), the design of the production and control procedures (§ 211.100), or the design of laboratory controls (§ 211.160). The current standards require that a risk-based approach utilizing scientific knowledge is used when implementing a change. The effect of the change should be evaluated, including any unintended, negative consequences. Evaluating the effects of a change can encompass additional tests or examinations of subsequent batches (e.g., additional in-process testing or additional stability studies), and is an important process in maintaining the validated state of the equipment and processes. Through interactive examples, this course will teach the process by which change management should be used to identify, evaluate, document, approve, implement, and close changes made throughout the product lifecycle.
By the end of the course, participants will be able to:
- Describe when change control should be applied.
- Discuss how to fully evaluate changes and their impact to maintaining a validated state and process.
- Create scientific and risk-based justifications and rationale for implementation of changes.
- Use best practices for implementation of changes and document completion of changes.
- Learn when and how to apply changes throughout the product lifecycle; with varying levels of formality applied based upon scientific and risk-based knowledge.
Course Outline:
- Regulatory requirements and expectations; link to ICH Q10
- The role of change control in maintenance of a validated state and process improvement
- Utilizing Quality Risk Management in the change management process
- Identification of changes
- Evaluation of change impact
- Documentation
- Like-for-like assessments
Who Should Attend:
Quality assurance, quality control, regulatory affairs, validation, manufacturing, technical support, IT, supply chain, and engineering professionals in the pharmaceutical, biopharmaceutical, or medical device industry.
All levels of management and service providers and vendors who serve pharmaceutical, biopharmaceutical or medical device industry clients
Prerequisites:
No prerequisites.
Cost: Half-day class
Location: Location and driving directions will be emailed separately upon registration.
