Referent:innen

Michael Hopper

Michael Hopper

GXPPRO

Marcus Heinbuch

Marcus Heinbuch

B. Braun Melsungen

Dr. Jens-Uwe Rengers

Dr. Jens-Uwe Rengers

vorm. Akorn

Sandra Schäffler

Sandra Schäffler

GMP/GDP Inspectorate

Zielsetzung

During this Live Online Training, 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.

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.

Programm

Deviation Management and CAPA

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.”

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
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.

ECA-Member*: € 1690,-
Non ECA Member*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

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Teilnehmerstimmen - das sagen andere über unsere Seminare:

"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen.
Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.”
Christian Wagener, WAGENER & CO. GmbH
GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024

„Danke für das tolle und interessante Seminar! Ich nehme mir fachlich total viel mit und habe viele tolle Menschen kennengelernt.“
Melanie Schifferer, DAIICHI SANKYO EUROPE GmbH
Batch Record Review (QS 23)
September 2024

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

„Interessante Themen, gut vorgetragen, die eigenen Erfahrungen der Vortragenden helfen, dies noch besser nachzuvollziehen.“ „Gute Gestaltung der Workshops, das Zusammenarbeiten in Gruppen und der Austausch mit anderen hilft sehr.“
Manuela Seibert, Merck, GMP-Leadauditor/in (FA 2), April 2024

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