This 60-minute webinar includes a discussion of advanced techniques for inspection of manufacturing systems. We will discuss specific inspectional approaches that provide risk-based oversight of complex and diverse manufacturing operations (APIs and drug products), from raw materials to the finished product. We will address how an investigator may approach inspection of an unfamiliar SCADA or other equipment control software, as well electronic batch records and notebooks. Inspection of the manufacturing system involves the ability to allocate limited time & resources to those areas of greatest reward – with the ultimate goal of achieving company-wide improvements based on the identification of individual findings/observations. Inspectional time management, therefore, is a key component for success, and can be achieved most effectively through a risk-based approach using critical thinking. This webinar will discuss practical inspection approaches that an investigator may apply for quick and effective identification of areas of concern, with the goal of achieving long-lasting system-wide improvements that ultimately lower costs and result in the production of a higher quality product.
We will discuss:
Specific examples of how to perform a risk-based data review within an unfamiliar SCADA/DCS
Risks when using electronic batch records and notebooks
How to review data within a data historian
How to identify triggers during a paper-based inspection
Effective interview techniques
Critical thinking during an inspection
What are triggers and how do I identify them?
In addition, for those interested, this webinar offers an additional 30 minutes for Q&A upon completion of the presentation.