Ingo Ebeling, Abbott Products
Melanie Kinzner, Sandoz International
Katja Kotter, Vetter Pharma-Fertigung
Sue Mann, Sue Mann Consultancy, UK
During this course you will learn how the various pharmaceutical quality and documentation systems work and how they interact. Experts from the pharmaceutical industry will show you possibilities to improve your systems and how to run them efficiently and in compliance with (c)GMP.
Pharmaceutical Quality Assurance and GMP Compliance Managers are continuously facing new challenges due to changing regulatory requirements and at the same time increasing needs for efficiency.
In this context, GMP-Compliance Managers must be familiar with many GMP-related aspects and systems like:
- Non-Conformance Management
- Change Management
- Continuous Improvement
- Quality Risk Management
- Quality Reports
And these are not stand alone systems. They are all linked to each other: A Deviation causes a Failure Investigation which is followed by a CAPA that can lead to a Change and Change Control. All relevant information must be documented in the PQR and APR and Risk Management is the key to almost everything. And everything should be integrated in a Pharmaceutical Quality System.
Companies should have all these systems in place. Let’s find out how we can get the most out of them!
This course is designed for all persons in pharmaceutical, biopharmaceutical and API industry’s production and quality units who establish, manage and improve quality and documentation systems.
Current Regulatory Developments and their Impact on Quality Assurance: Challenges and Opportunities
Documentation Systems and their Compliance with the Marketing Authorisation
- ICH Q8 & Q9 – approach and implementation
- ICH Q10 - integration of the Quality Management System
- Chapter 1 of the EU-GMP Guide – implications of recent updates
- The Falsified Medicines Directive – new requirements for the Quality Management System
Deviation and Failure Investigation
- Regulatory requirements on batch documentation
- Document change management: maintaining compliance
- Records retention
- How to keep track of raw data/GMP relevant documentation
- Language: local language vs. English; quality of translation
- Issue/training/effective date vs. new document version
- cGMP Requirements/ Expectations
- Deviation management - Best industry practice
- Performing Failure Investigations – practical approaches (interdisciplinary teams, differential diagnose, visualisation, mind mapping)
- Recommendations for a good report
- Business Process Failure Investigation – What to define in the local procedure?
Batch Record Review
- Philosophy and background
- cGMP requirements and expectations
- CAPA Subsystems
- Success factors for an integrated system
- Industry approaches for CAPA Systems
- Steps to consider for a successful BRR
- Responsibilities: manufacturer vs. supplier vs. contractor and QA vs. production vs. lab
- KPIs: examples and possible improvements to reduce review cycles times
- Deviations: how to handle during BRR/ transfer into CAPA system/ impact on batch release
Product Quality Review and Annual Product Review as Quality Enhancement Tools
- What is affected by Change Control?
- The process of Change Control
- Emergency changes
- Change Management in a global environment
Risk Analysis and Management
- Best practices in combining the two reviews
- Statistical background and trending
- Timing of PQRs with discussion around product groupings
- Responsibilities: who is responsible for generation of particular parts of the report, analysis and final conclusion
- Site specific versus product specific PQR
- Challenges and recommendations to overcome challenges
- Examples and case studies
How the Systems are connected
- The Principles of Risk Analysis
- A detailed look at FMEA and HACCP
- How to apply ICH Q9 “Quality Risk Management”
- Process improvement with Risk Analysis
3 parallel Workshops:
- System Integration of Batch Record Review, Deviation Management, CAPA,
- Change Control and PQR
1) Deviations - Failure Investigation - CAPA
2) Integration of a Pharmaceutical Quality System: What does it mean in practice?
3) Risk Management in Supplier Qualification: How to reduce the effort of qualification without losing control and become non-compliant
You will be able to attend 2 of these workshops. Please choose the ones you like to
attend when you register.