*NEW COURSE ADDED* OVERVIEW OF CLEANING VALIDATION
Designed in response to the updated requirements, this half-day overview is designed to ensure that all personnel involved in performing, sampling, testing, and approving cleaning validation protocols understand the process and current expectations.
When Chapter 1 of Eudralex Volume 4 (GMP) was updated in Jan 2013, it included a requirement to look BEYOND Human Error in Quality Investigations. This ONE DAY Course is designed to assist management in identifying how to address, manage and reduce human error root causes in quality investigations. With many years’ experience of auditing and training, Valerie Mulholland has observed many strategies for tackling this issue. She has now taken the best of these ideas and presents them in one course. We are not selling a strategy or a solution – simply opening a toolkit of possible approaches that could be applied to your organization.
Since the publication of ICH Q9, root cause analysis tools should be used as part of complaint, deviation and failure investigations. This half-day course is designed to overview some of the techniques that can be used, e.g. fish bone diagrams, the 5 whys, process mapping and more….
Aimed at improving the quality of GMP documentation, this topic can be covered in one or two modules, each lasting approx. HALF DAY. The first module looks at the latest considerations when writing procedures and associated forms. Designed to contribute to human error reduction, the course suggests approaches that should improve these documents.
The second optional module, looks at writing common GMP reports, such as deviation or complaint investigation reports. Looking at common pitfalls, the session overviews skills to assure that these documents are clear and accurate reflections of events.