Deviation Management and CAPA - Online Training Recording
Course No. 21713
Speakers
Michael Hopper
GXPPRO
Marcus Heinbuch
B. Braun Melsungen
Dr. Ulrich Herber
Charles River Laboratories
Dr. Jens-Uwe Rengers
vorm. Akorn
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
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
Testimonials