Dr Felix Kern
Merck Healthcare
Referent:innen
Dr Rainer Gnibl
GMP Inspector
Zielsetzung
This Live Online Session will provide you with important information on the regulatory background and the successful implementation of self-inspections.
Hintergrund
Self-inspections are a requirement in EU-GMP but also FDA:
- EU GMP Guideline Part 1, Chapter 9 Self Inspection: “Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.”
- EU GMP Guideline Part 2, Chapter 2.5 Internal Audits: “In order to verify compliance with the principles of GMP for APIs, regular internal audits should be performed in accordance with an approved schedule.”
The results and observations from self inspections provide evidence of the effectiveness of the existing quality assurance system. A self-inspection is a tool for evaluating and continuously improving the suitability and condition of systems, processes, equipment and premises. However, self-inspections have their own character and require careful planning, implementation and follow-up.
Zielgruppe
This Live Online Session is aimed at auditors and managers from the pharmaceutical and active pharmaceutical ingredients industry who plan, carry out and support self-inspections.
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 presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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 presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programm
Regulatory Requirements
- Goal and purpose of the self-inspection
- Expectations regarding planning, implementation and follow-up
- GMP-compliant self-inspection reports
The Implementation of Self-Inspections
- Organisation, planning and preparation
- Audit Team
- Topics and focal Points
- Duration
- What needs to be considered during implementation?
- Follow-up
Recording from 12.09.2024
Duration of the recording: 2.5 hours
Duration of the recording: 2.5 hours
| 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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