Ingo Ebeling, Abbott Products
Melanie Kinzner, Sandoz
Dr Ulrich Kissel, European QP Association
Katja Kotter, Vetter Pharma-Fertigung
Sue Mann, Sue Mann Consultancy, U.K.
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, QA and GMP Compliance Managers must be familiar with many GMP-
related aspects and systems like:
- Non-Conformance Management
- Quality Risk Management
- Document and Data Governance
- Monitoring and 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 Quality Reviews and Risk Management is the key to almost everything. And everything should be documented and data handled in an integer way.
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 the Quality Management System: Challenges and Opportunities
Deviation - Investigation – CAPA
- New and relevant EU GMP requirements for the Quality Management System
- ICH Q8, Q9 and Q10 – approach and implementation
Risk Analysis and Management
- GMP requirements and expectations
- Deviation management: best industry practice
- Performing Failure Investigation
- Elements of investigations
- CAPA-System and elements
- Success factors for an integrated system
- Industry approaches for CAPA systems
- 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
Compliance Strategy und Compliance Project Management
- What’s it all about (where does the hype come from)
- What you need to know about it
- What are inspectors looking for?
Documentation Systems as a Foundation
- Setting up a strategy for compliance management
- Quality oversight
- Business case study
How to control the Flow of Documents
- Regulatory requirements
- 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
Product Quality Review and Annual Product Review as Quality Enhancement Tools
- Review and approval of Documents
- Batch Record Review process
- GMP process and data flow
- Documentation vs. Data integrity issues
Case Study: How to monitor Suppliers
- Best practices in combining the two reviews
- Statistical background and trending
- Timing of PQRs
- 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
3 parallel Workshops:
- Key Quality and Performance Indicators
- Reporting and Monitoring (trend analysis and targets)
- Who is involved – who is responsible?
- Outlook: the FDA Guidance on Quality Metrics
1) Deviations - Failure Investigation - CAPA
2) Quality Metrics and KPIs: from Data Collection to Continuous Improvement
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.