Self Inspection - Live Online Training

Thursday, 12 September 2024 13.00 - 16.45 h

Course No. 21345



Dr. Rainer Gnibl

Dr. Rainer Gnibl

GMP Inspektor, Regierung von Oberbayern

Dr Felix Kern

Dr Felix Kern

Merck Healthcare

All times mentioned are CEST.


This Live Online Session will provide you with important information on the regulatory background and the successful implementation of self-inspections.


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.

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.

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.


Self Inspection - Live Online Training

Seminar Programme as PDF

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

ECA-Member*: € 590,-
Regular Fee*: € 690,-
EU/GMP Inspectorates*: € 590,-
APIC Member Discount*: € 640,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
Further dates on-site
Not available
Further dates online
Further dates online
Not available
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023


“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
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“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024



“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023