Compliance Training


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.

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compliance trainingHUMAN ERROR TOOLBOX

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.

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compliance trainingROOT CAUSE ANALYSIS TOOLS

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….

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compliance trainingWRITING GMP DOCUMENTS

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.

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compliance trainingAUDITING FOR GMP

Periodically auditing for GMP compliance is a regulatory requirement. This not only requires a thorough understanding of the regulations, but also an insight into how they are being applied.

Do you auditors know how to keep current with what is being found in regulatory inspections?

It is essential that auditors understand these requirements and the importance of the function that they perform. Many inexperienced auditors have difficulty establishing when an issue is

an issue and the appropriate corrective action required.

We take people through the skills required to prepare, conduct and report on Internal Inspections, so that the inspections are value added and help avoid regulatory issues for the company.

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