Dr. Karl-Heinz Bauer
Boehringer Ingelheim International
Referent:innen
Zielsetzung
In this Live Online Training you will learn how to introduce and maintain your CAPA system in quality control in accordance with GMP requirements. You will get to know how CAPA can be integrated into the QM system and which specific steps should be initiated to reduce the error rate in the laboratory.
You will get an overview of how you can use selected CAPA measures in quality control to help avoid errors and thus increase efficiency in analysis.
You will get an overview of how you can use selected CAPA measures in quality control to help avoid errors and thus increase efficiency in analysis.
Hintergrund
The processing of laboratory errors is a legally mandatory but usually very time-consuming task in many laboratories. Expensive resources are tied up with troubleshooting and the implementation of repeat analyzes, which in turn reduces the efficiency of the laboratory.
In view of the growing cost pressure and the high complexity of many analytical devices and procedures, this is particularly problematic, because the increasing load encourages additional errors and thus causes a situation that is becoming increasingly difficult to resolve. The required quality of quality control can only be maintained or regained with suitable systematic procedures.
In the more recent regulations, CAPA is expressly required, so that the inspection relevance for it has increased steadily in recent years.
In view of the growing cost pressure and the high complexity of many analytical devices and procedures, this is particularly problematic, because the increasing load encourages additional errors and thus causes a situation that is becoming increasingly difficult to resolve. The required quality of quality control can only be maintained or regained with suitable systematic procedures.
In the more recent regulations, CAPA is expressly required, so that the inspection relevance for it has increased steadily in recent years.
Zielgruppe
This Live Online Training is specifically designed for
- laboratory managers,
- GMP assistants,
- QA officer,
who have not yet developed systematic CAPA processes or are in the process of establishing or optimizing them.
Employees and managers from the pharmaceutical industry are also addressed, especially from the following laboratory areas:
Employees and managers from the pharmaceutical industry are also addressed, especially from the following laboratory areas:
- incoming goods inspection,
- in-process and finished goods control,
- analytical development,
- active ingredient and excipient testing,
- and contract/service laboratories.
Finally, the seminar is also developed for employees and Managers from quality assurance units.
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical- information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Welcome and Introduction
CAPA and CAPA in QC Labs
- Terms and definitions
- Regulatory requirements
- Non-conformities
- Controlled handling of non-conformities
- The CAPA System
- Triggers of CAPA operations
- Structure of the CAPA process
- CAPA in quality Control
- Classification and clustering of typical laboratory problems
Questions and Answers (Session 1)
Understanding and Preventing Human Errors
- What is human error?
- Definition, Categories, and psychology of human error
- The right attitudes and behaviors for adequate error investigations
- The vicious cycle of „guilt“
- The right „error culture“
- Snappy exercises
Concepts to Prevent Lab Errors in QC & Practical Exercise to Define Adequate CAPA Measures
- Terms, definitions, and requirements for error prevention
- Sources of errors, its investigation in the laboratory and the resulting prevention measures
- Development stages of an integrated quality, error, and improvement culture
- Typical deficiencies from health authority inspections
- Examples and practical exercises to define suitable CAPA measures
Questions and Answers (Session 2)
In two live discussion rounds, there is the opportunity to ask questions which will be answered by the speaker.
In two live discussion rounds, there is the opportunity to ask questions which will be answered by the speaker.
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 590,- |
| APIC Member Discount*: | € 640,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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