Seminar Nr. 9304
Tel.: 06221 / 84 44 0 E-Mail: firstname.lastname@example.org
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:
Quality Risk Management
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 Opprtunities
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
Documentation Systems and their Compliance with the Marketing Authorisation
Regulatory requirements on batch documentation
Document change management: maintaining compliance
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
Deviation and Failure Investigation
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?
Philosophy and background
cGMP requirements and expectations
Success factors for an integrated system
Industry approaches for CAPA Systems
Batch Record Review
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
What is affected by Change Control?
The process of Change Control
Change Management in a global environment
Product Quality Review and Annual Product Review as Quality Enhancement Tools
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
Risk Analysis and Management
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
How the Systems are connected
System Integration of Batch Record Review, Deviation Management, CAPA,
Change Control and PQR
3 parallel Workshops:
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
You will be able to attend 2 of these workshops. Please choose the ones you like to
attend when you register.