Why should you attend?
If you are a professional who is involved in the planning, design, purchase, qualification, validation, and continuous lifecycle management of facilities and equipment, this webinar is for you. In this session we demystify the lifecycle risk-based approach to qualification of facilities and equipment, which is vital to successful process validation of pharmaceutical/ biopharmaceutical products, as well as to sustainable and reproducible manufacturing activity. We will review case studies from recent regulatory observations, which will help you learn from other companies’ shortcomings. Finally, we discuss why digitization as a preferable and sustainable approach to lifecycle management is necessary.
- Risk Based Approach
- Design of Facilities and Equipment
- Installation Qualification Concept
- Operation Qualification – What is Involved
- Performance Qualification for Equipment and Facilities
- Sampling Schemes
- Data Analysis
- Continued Verification
Key learning objectives:
- Dispel mistaken paradigms regarding the risk-based approach to the Qualification of Facilities and Equipment lifecycle.
- Understand how to eliminate variability – the cause of most deviations.
- Understand how to best design facilities and equipment that would support manufacturing that will continually meet product and process requirements.
- Capitalize on the advantages of on-line analytical instrumentation (temperature, relative humidity, and even microbiological rapid methods).
Who will benefit?
The information shared in this webinar will benefit all levels – from senior management to those who are involved in the operation of Facilities and Equipment on a day-to-day basis. This webinar is particularly targeted at the following organizational positions and disciplines.
- Quality Assurance/ Quality Control (Chemistry and Micro)
- Process and Design Engineering
- Process Automation
- Manufacturing Operations
- Utility Operations
- Regulatory Affairs