Michael Hopper
GXPPRO
Referent:innen
Marcus Heinbuch
B. Braun Melsungen
Dr. Jens-Uwe Rengers
vorm. Akorn
Sandra Schäffler
GMP/GDP Inspectorate
Charis Schmidt
Ferring
With Workshop, Examples and Q&A Sessions
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.
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.
Programm
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
- 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
Possible Use of AI in Deviation and CAPA Management
- The idea – A start from the scratch
- Development and approach
- Examples: how to & how not to
- Current learnings: benefits and limits
- A vision for the future
CAPA Effectiveness & System Performance Check
- CAPA Effectiveness
- Why assessing effectiveness
- The meaning of effectiveness
- Determine effectiveness
- System Performance
- Performance Monitoring
- Examples of Performance Indicators
Question and Answers
Sufficient time has been set aside to answer your questions.
Sufficient time has been set aside to answer your questions.
Weitere Informationen
Venue
Barceló Hotel Hamburg
Ferdinandstrasse 15
20095 Hamburg, Germany
+49 (0)40 22 63 62 0
hamburg@barcelo.com
Barceló Hotel Hamburg
Ferdinandstrasse 15
20095 Hamburg, Germany
+49 (0)40 22 63 62 0
hamburg@barcelo.com
Accommodation
CONCEPT 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 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
In the evening of the first day, 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.
In the evening of the first day, 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 € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice and includes lunch on both days, dinner on the first day and all refreshments.
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice and includes lunch on both days, dinner on the first day and all refreshments.
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.
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 official conference language will be English.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 (0)6221 84 44 22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
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.
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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E-Mail: info@concept-heidelberg.de
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