Katja Kotter
Vetter Pharma-Fertigung
Referent:innen
Ingo Ebeling
Abbott Laboratories
Melanie Kinzner
Sandoz
Dr Sue Mann
Sue Mann Consultancy
Sebastian Rögner
Croma-Pharma
WITH 3 WORKSHOPS
Zielgruppe
- GMP-Compliance Managers and Officers
- QA Managers
Zielsetzung
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.
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!
Companies should have all these systems in place. Let’s find out how we can get the most out of them!
Programm
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.
Weitere Informationen
Venue
DoubleTree by Hilton Berlin Ku´Damm
Los-Angeles-Platz 1
10789 Berlin, Germany
+49 30 2127 714
alexander.kliche@eventhotels.com
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.
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.
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.
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.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 27 October 2026, 9:00–17:30 h
Wed, 28 October 2026, 08:30–15:30 h
Wed, 28 October 2026, 08:30–15:30 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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