Training · Risk Management

Seeing risks before they happen

One day, intensive and interactive: practical application of ICH Q9 in hospital pharmacies, the pharmaceutical industry, and related sectors — from regulation to workable risk analysis.

SSeverity

LLikelihood

DDetectability

RPNInsight

Risk analysis and management was, for a long time, a relatively underexposed activity in the hospital and pharmaceutical world. With the inclusion of ICH Q9 in European GMP, risk management suddenly became a hot topic. However, the regulation leaves considerable room for interpretation regarding how and when to apply risk management.

On one hand, this has led to arbitrary, unsystematic application of the regulation; on the other, to overkill in risk analyses. This training provides practical guidance for the correct application of the regulation.

Program

BackgroundOrigin and structure of the regulation (ICH Q9)

Risk analysis theorySeverity, Likelihood, Detectability, and RPN

Risk management theoryThe full Quality Risk Management process

When (not) to apply itDetermining scope and depth, avoiding overkill

CAPA & risk mitigationFrom risk to corrective and preventive action

ImplementationBest practices for embedding it in practice

Case studies

Sterile manufacturing process

Risk analysis of an aseptic manufacturing process to determine the scope and depth of process validation.

Repackaging & artwork

Manual versus machine repackaging following a text error on the packaging — including root cause and CAPA.

Also practically applicable to

ReleaseRisk assessment in product release

Root cause & CAPAFrom symptom to underlying cause