Dr Rainer Gnibl, District Government of Upper Bavaria, Germany
Dr Felix Kern, Merck, Germany
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.
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.
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.
- 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
- What needs to be considered during implementation?