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GMP Courses and Conferences
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Tuesday, 24 February 2026 13.00 - 16.30 h
Speakers
Dr Rainer Gnibl, District Government of Upper Bavaria, Germany
Dr Felix Kern, Merck, Germany
Dr Felix Kern, Merck, Germany
Objectives
This Live Online Session will provide you with important information on the regulatory background and the successful implementation of self-inspections.
Background
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.
Background
Tue, 24 February 2026, 13–16.30 h
All times mentioned are CET.
Target Group
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.
Programme
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
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technicalinformation 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.
Fees (per delegate plus VAT)
ECA Members EUR 590
APIC Members EUR 640
Non-ECA Members EUR 690
EU GMP Inspectorates EUR 590
The conference fee is payable in Advance after receipt of invoice. The Registration does not include ECA Membership.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding Organisation:
Mr Ronny Strohwald, +49 (0)6221 84 44 51, strohwald@concept-heidelberg.de
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technicalinformation 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.
Fees (per delegate plus VAT)
ECA Members EUR 590
APIC Members EUR 640
Non-ECA Members EUR 690
EU GMP Inspectorates EUR 590
The conference fee is payable in Advance after receipt of invoice. The Registration does not include ECA Membership.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding Organisation:
Mr Ronny Strohwald, +49 (0)6221 84 44 51, strohwald@concept-heidelberg.de