ICH Q 9 - Quality Risk Management: an Overview
- QRM in non-GxP industries
- QRM in pharma
- Historical GMP situation
- Current rules and regulations
- QRM tools and techniques
How to implement Quality Risk Management in a pharmaceutical Company
- QRM Tools made practicable in daily QRM life
- Comparison of ICH Q9 with other Norms and takeaways for Pharma
- Strength of practical DMAIC methodology
- QRM culture: principles and examples
- Cost of Quality/Compliance
The Inspector’s View
- Expectations
- Integration in the Pharmaceutical Quality System
- Examples for good and not so good practice
How to realise Quality Risk Management in a GMP Environment
- Integration
- SOPs
- Applications
- Commissioning
- QP Dispositioning
How to apply Quality Risk Management in Validation
- Application of Risk Assessment for Process ValidationRisk Assessment over the Product Life Cycle Risk based Quality by Design (QbD) approach
- Examples
Workshop:
Applying Principles of QMR after an Incident
A problem has occurred – how to perform a sound Risk Assessment of the situation and come to an appropriate decision.
Design of an Event Handling System based on a Quality System and Quality Risk Management
- Approach
- QRM in the Quality System
- Design of an Event Handling system based on QRM and Management Review
- Use of QRM in the evaluation of events
- Examples
Presentation and Exercise on Risk Management in the Supply Chain
An interactive session to establish where to best concentrate your resources to maximise the assurance of a reliable supply chain:
- Requirements
- Life cycle of the supplier relationship
- Frequency of Supplier Audits based on Risk Assessment
- Defining risk in the audit program
- Compliance risk assessment
After the session you will be able to use or adapt the template to conduct a similar risk profile for your own facilities and third-party operations.
Interactive Session on Case Studies
The term “quality risk management” is used throughout the GMP guidelines. In this session you will get some practical advice and work with scenarios requiring a decision.