Operator Inspection Readiness: A Practical Perspective
Overview
Regulatory inspections are crucial in the biopharmaceutical industry to ensure that products meet the highest standards of quality and safety. Manufacturing operators play a pivotal role in the success of these inspections. Their preparedness can have a key impact on the outcome of an inspection. Well-prepared operators can demonstrate compliance, effectively communicate processes and procedures, and address any inspector queries confidently. This not only aids in successful inspections but also fosters a culture of quality and continuous improvement within the organization.
This one-day, in person course at NIBRT Dublin is designed to equip manufacturing operators in the biopharmaceutical industry with the knowledge and practical skills necessary to prepare for regulatory inspections. Participants will gain a comprehensive understanding of the inspection process, the critical role of operators during inspections, and best practices for inspection preparation.
Key topics covered
- Introduction to Regulatory Inspections and Regulatory bodies (EMA, FDA, HPRA)
- Regulatory Inspection processes and guidelines
- Role of Manufacturing Operators
- Inspection Readiness Strategies
- Practical Exercises for Operator Readiness
Who should attend
Manufacturing operators and individuals directly involved in the production processes who need to understand their role during inspections. This course is also ideal for manufacturing organisations looking to better prepare their teams for the inspection process and build confidence for a successful inspection.
What do Attendees Obtain on Completion?
Attendees will receive a certificate of attendance.
Register
Course Format
Onsite Training at NIBRT
- 1 full day onsite training at NIBRT facility
