Deviation Management and CAPA

11/12 March 2025, Barcelona, Spain

Course No. 21642

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Speakers

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

Objectives

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.

Background

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.

Target Group

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

Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona, Spain
Tel. +34 (93) 503 53 00
E-Mail: sants@barcelo.com

Programme

Deviation Management and CAPA

Seminar Programme as PDF

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.

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This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more

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

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Further dates on-site
Further dates on-site
Not available
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Further dates online
Further dates online
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Recording
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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