Deviations and CAPAs - Perform effective investigations

Quality Operations Laboratory GMP
Training
  1. Short description
  2. Objectives
  3. Target group
  4. Program
  5. Questions?
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This one-day course focuses on the root cause analysis and impact assessment of deviations and the determination of appropriate corrective and preventive actions.

Duration
1 day
Course fee
€ 795 (excl. VAT)

Short description

When manufacturing pharmaceutical products, unexpected events can occur, for instance during production, analysis, transport, storage or even during the qualification and/or calibration of equipment. In the pharmaceutical industry these events are called deviations or non-conformances.

Deviations could have a negative effect on the quality of the pharmaceutical products and could even result in a recall of the products. Furthermore, these deviations could be an indication that the quality system is functioning suboptimally.

For the abovementioned reasons, it is of the utmost importance to investigate these deviations. In such an investigation the following aspects are essential:

  • root cause analysis, to determine why the deviation occurred.
  • impact assessment, to determine the (possible) consequences of the deviation
  • define corrective and preventive actions (CAPA), to be sure that correct actions were taken to immediately reduce the impact of the deviation, and to prevent the deviation from re-occurring.

Objectives

At the end of the training, participants have the following knowledge and skills:

  • Know which aspects are important for a valid deviation and why
  • Identify the aspects to be used when describing a deviation
  • Use of various techniques to carry out a risk analysis
  • Determine appropriate CAPAs
  • Draw up effectiveness measurements for CAPAs

Target group

This training is developed for production, validation, and technical personnel, and people working in process development and QC departments. This training is also very suitable for professionals involved in deviation investigations and/or the management of such a deviation system.

Program

Day 1

 

Description of the event

• What are important inputs for a CAPA system?
• Which aspects are important for the description of an event?
• Which information is essential to complete the description?
• How to make a clear and concise description.
 

Analyses of the Root Cause

The following different methods for root cause analyses will be explained and practiced:
FTA (fault tree analyses)
• Chronological data analyses
• Ishikawa Diagram
• Yes/No analyses
The following subjects will be discussed:
• Data analyses
• Deduction of possible causes
• Questioning techniques
 

Performing an Impact Assessment

• How to make a quick estimate of the impact of the event?
• How to perform an effective Impact Assessment?
• Which factors are of importance when performing an Impact Assessment?
• How to use the FMEA technique for determining the impact?
 

Determining and implementing Corrective and Preventive Actions

• What are “immediate” corrective actions?
• What is the difference between corrections, corrective actions and preventive actions?
• How to determine the right correction?
• How can the effectivity of the CAPA be measured?

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

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Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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