Quality Assurance

What an Annual Product Quality Review needs to cover and how findings should be used.

What a Qualified Person must verify before certifying a batch for release under EU GMP.

How a CAPA system is structured under the ICH Q10 pharmaceutical quality system model.

How a change control process evaluates and manages the risk of planned changes in a GMP facility.

How a structured root cause analysis process turns a deviation into a real corrective action.

What a compliant document control system needs to manage SOP lifecycle and record integrity.

What evidence to ask for, what a certificate can and cannot prove, and how to turn the answers into a documented approve, conditionally approve or reject decision.

How recalls are classified by risk level and what notification obligations follow from each class.

A comparison of common ICH Q9 risk management tools and when each is the right fit.

How a self-inspection program is scheduled, scoped, and used to drive continuous improvement.

How raw material suppliers are risk-assessed, audited, and approved under a supplier qualification program.