This 60-minute webinar includes a discussion of advanced techniques for the inspection of QC laboratory systems. We will discuss specific inspectional approaches that an investigator may take to provide risk-based oversight of analytical and microbiological test methods, instrumentation, and procedures (APIs and drug products), including raw materials, intermediates, and finished product. Effective auditing 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 provide practical inspection approaches that an investigator may apply throughout the product lifecycle, including R&D/development laboratories, 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:
Inspections of application data within R&D/development laboratories
Inspecting microbiology
Reviewing electronic data in unfamiliar QC systems
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.