Michael Hopper
GXPPRO
Referent:innen
Marcus Heinbuch
B. Braun Melsungen
Dr. Jens-Uwe Rengers
vorm. Akorn
Sandra Schäffler
GMP/GDP Inspectorate
Zielsetzung
During this training course, you will get to know the principles and discuss all relevant aspects to implement, improve and/ or work with a Deviation Management and CAPA System. Furthermore, you will get to know possibilities and tools to monitor and evaluate your CAPAs.
Hintergrund
Things will go wrong from time to time. In the world of pharmaceuticals, we need to ensure that we have robust processes and procedures in place to deal with such situations. When an unplanned event arises it must be handled accordingly.
FDA’s Quality System Guide, recent Warning Letters and EU-GMP Chapter 1 clearly emphasise the increasing relevance of a proper deviation management and CAPAs. ICH Q9 on Quality Risk Management and ICH Q10 on Pharmaceutical Quality Systems empower us to handle issues that arise in our daily work on the basis of risk analysis.
In any case a sound failure investigation is the key to identify appropriate CAPAs. Here it is also important to know how to deal with human error based and non-human error based non-conformances.
Independent from that, it needs to be pointed out that CAPA is an excellent Quality Management tool to continuously improve processes and avoid future failures. All personnel involved in the management of deviations and CAPAs should aim to identify opportunities for further improvement.
Zielgruppe
This course is designed for all personnel involved in Deviation Management and CAPA activities at their company. It is addressed to persons from Quality Assurance and Control, Manufacturing and R&D.
Date & Venue
Date
Tuesday, 11 March 2025, 09.00 – 17.30 h
(Registration and coffee 8.30h – 9.00h)
Wednesday, 12 March 2025, 08.30 – 15.30 h
Tuesday, 11 March 2025, 09.00 – 17.30 h
(Registration and coffee 8.30h – 9.00h)
Wednesday, 12 March 2025, 08.30 – 15.30 h
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona, Spain
Tel. +34 (93) 503 53 00
E-Mail: sants@barcelo.com
Programm
Gesamtes Programm als PDF herunterladen
Expectations in dealing with Deviations and CAPAs from the Perspective of the Authority
- Focus in inspections
- Documentation of deviations and CAPAs with deadlines for processing
- Trend analysis of deviations within the scope of the PQR
- Recording of deviations as part of the self-inspection
- Initiation of CAPA
Excerpt from FDA Warning Letter
“…the investigation failed to establish a root cause and your quality unit failed to ensure the implementation of adequate corrective actions to prevent future recurrence.”
“…the investigation failed to establish a root cause and your quality unit failed to ensure the implementation of adequate corrective actions to prevent future recurrence.”
Deviation Handling
- How to document deviations
- Information and Data Management
- Critical/ major/ minor
- CAPA or not?
CAPA: Principles, System, Implementation and Process Improvements and the use of Risk
Management Techniques
Management Techniques
- Root Cause Analysis Tools
- Quality Risk Management
- Human Error Overview
- Monitoring & Evaluation Overview
Workshop:
- An interactive exercise on scenarios with a focus on using the tools from the presentation
- Human Error based
- Non-human error based
Harmonisation in dealing with Deviations at international Level
- Regulations of the FDA and the WHO Expert Committee on Specifications for Pharmaceutical Preparations and comparison with the European requirements
- Exchange of experience in dealing with deviations in third countries and regulatory requirements exemplified by India
- Goal: Harmonisation at international Level
Case Study:
- How to implement a CAPA System
- How to integrate existing QM Systems (OOS, Complaint Handling, Deviations)
- Examples and lessons learned
Case Study:
- Implementation of a Software Tool for CAPA Management
- Understanding your workflows and processes
- Can you improve the current process using electronic workflows?
- Efficient validation of a CAPA application
CAPA Effectiveness & System Performance Check
- CAPA Effectiveness
- Why assessing effectiveness
- The meaning of effectiveness
- Determine effectiveness
- System Performance
- Performance Monitoring
- Examples of Performance Indicators
Questions & Answers
Sufficient time has been set aside to answer your Questions.
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This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
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E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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