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.
Background 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!
Programme
Current Regulatory Developments and their Impact on the Quality Management System: Challenges and Opportunities
New, revised and relevant GMP requirements for the Quality Management System
Deviation - Investigation - CAPA
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
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
IT-Tools for the Pharmaceutical Quality System
Possibilities and limits of an electronic Quality Management System (eQMS)
Possible process flows in the eQMS
Implementation and life cycle of an eQMS
Data Integrity: Background and points to consider (what the GMP-Compliance Manager needs to know)
Outlook: Artificial Intelligence (AI) and GMP: possibilities and limits
Documentation Systems and their Compliance with the Marketing Authorisation
Regulatory requirements
Document change management:
Maintaining compliance
Records retention
Archiving
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
How to control the Flow of Documents
Review and approval of Documents
Batch Record Review process
GMP process and data flow
Documentation vs. Data integrity issues
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
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
Case Study: How to monitor Suppliers
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
3 parallel Workshops:
Deviations - Failure Investigation - CAPA
Quality Metrics and KPIs: from Data Collection to Continuous Improvement
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.
Further Information
Venue DoubleTree by Hilton Berlin Ku´Damm Los-Angeles-Platz 1 10789 Berlin, Germany +49 30 2127 714 alexander.kliche@eventhotels.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Social Event On 27 October, you are cordially invited to a social event (city tour and dinner). This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate plus VAT) ECA Members EUR 1,890.- APIC Members EUR 1,990.- Non-ECA Members EUR 2,090.- EU GMP Inspectorates EUR 1,045.- The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
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