Deviation Management and CAPA - Online Training Recording

Course No. 21713

header-image

Speakers

Michael Hopper

Michael Hopper

GXPPRO

Marcus Heinbuch

Marcus Heinbuch

B. Braun Melsungen

Dr. Ulrich Herber

Dr. Ulrich Herber

Charles River Laboratories

Dr. Jens-Uwe Rengers

Dr. Jens-Uwe Rengers

vorm. Akorn

Sandra Schäffler

Sandra Schäffler

GMP/GDP Inspectorate

Objectives

During this 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.

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 EUGMP 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.

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs. In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

Programme

International Requirements – Rules and Regulations
  • European requirements
  • The expectations of the FDA
  • GMP and documentation issues
  • Harmonisation in sight?
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
  • Tools
  • Quality Risk Management
  • Human Error Overview
  • Monitoring & Evaluation Overview
Process Analysis and Failure Investigation
Scenarios with a focus on using the tools from the presentation before:
  • Human Error based
  • Non-human Error based
Deviations in the Light of Inspections
  • Focus in inspection
  • Trends, Product Quality Review and Product Review
  • Self-inspection as an important tool
Case Study: How to implement a CAPA System
  • How to integrate existing QM Systems (OOS, Complaint Handling, Deviations)
  • Examples and lessons learned
Case Study: How to deal with microbiological Deviations
  • Contamination control and company culture
  • What QA needs to understand
  • Interface with QA and production
  • OOS vs. deviation in the microbiological laboratory
  • Possible CAPAs
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
Recording from 20/21.03.2024
Duration of the recording: approx. 9 h 24 min

stop

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

ECA-Member*: € 1690,-
Regular Fee*: € 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

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available

Do you have any questions?

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

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023