This 60-minute webinar will continue the discussion into risk-based inspectional techniques for manufacturing systems, and will conclude with a look into formulating comprehensive observation responses. Writing and responding to findings from the manufacturing system involves a unique approach due to the diverse and highly configurable nature of the electronic systems used in a typical GMP operation, and the ability to write and communicate clearly often determines the difference between accepting or rejecting a batch (or worse). By framing the situation through a quality risk management (QRM) lens focusing on patient safety, we are able to communicate more clearly with those who may not have participated in the inspection but will ultimately make the final decision regarding the need to address the issue (or not).
We will discuss:
Case studies of previous significant regulatory actions (e.g. 483’s/Warning Letters)
How to write meaningful and effective responses using Quality Risk Management (QRM) tools
In addition, for those interested, this webinar offers an additional 30 minutes for Q&A upon completion of the presentation.