This 60-minute webinar includes a discussion of advanced techniques for inspection of the quality system. We will discuss specific inspectional approaches that provide risk-based oversight of the quality system (APIs and drug products), including document management, complaints, change control, and investigations, among others. 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. Pursuing the most meaningful observations, 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 inspection approaches that an investigator may use during the evaluation of the quality system, 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:
How to identify triggers during a review of paper-based GMP records
Identifying inadequate investigations that could lead to increased risk to product quality
Reviewing validation packages for unacceptable risk
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.