This 2-day virtual workshop (3 hrs/day) provides the unique opportunity to discuss investigation and corrective action strategies for both routine and complex investigations (e.g. deviations & OOS) using a systematic and risk-based approach.  GMP investigations require full engagement of our critical thinking skills due to the uncertainty that comes with loss of traceability, operating outside of the validated state, or the inability to make assumptions due to failure to follow procedures as expected.  This grey area often encountered during more complex investigations and remediation requires a higher level of attention by senior management and health authorities as a result of a manufacturing or testing environment that may be considered operating outside of the validated state.  Assumptions of product quality are now questionable, leading to tricky situations during the investigation process as we then rely on Quality Risk Management tools to guide us on appropriate actions.

Regulators require a wholistic, patient-centric approach to ensure patient protection, however, we continue to see investigation deficiencies regularly cited and often leading to significant regulatory action.  We will work through complex case-studies, utilizing individual critical thinking, interactive Q&A, available guidance and other resources to tackle realistic simulated investigations.  

Highlights include:

·       Initial actions and interim controls that can be taken to significantly reduce future burden and prevent grey-areas

·       Keys to success during root cause analysis

·       Keys to success when determining scope of the investigation

·       What happens when initial results (e.g., QC) cannot be invalidated, can we close the investigation?

·       Risk-based techniques to define product-impact when questions regarding integrity remain unanswered

·       Implementing meaningful patient-centric CAPAs

·       Working through complex case-studies where breaches in data integrity have been identified

At the conclusion of this workshop, participants will have gained the experience necessary to:

• Develop the critical thinking skill necessary to address uncertainty using risk-based tools according to ICH Q9 guidance

• Ensure assumptions made during the course of the investigation process are based on risk-based scientific rationale

• Train and educate colleagues on a systematic approach to investigations that ensures consistency across your organization

• Close investigations that may not have an assignable cause

• Propose and develop CAPAs based on scientific rationale & process knowledge

GMP Investigations & CAPA