You will understand the purpose and organisation of regulatory inspections and you will learn how to prepare your company to pass an inspection or customer audit and how to assure the most positive outcome.
Get practical knowledge of:
What inspectors are looking for
Successful preparation and management of inspections
Performing a MOCK-Inspection
Latest trends (with a view on virtual/remote inspections)
In addition, you will hear examples from global inspections to gain a better understanding of what is expected.
Background
GMP audits and inspections are fundamental elements of managing quality in the pharmaceutical industry. On the one hand, pharmaceutical companies have to perform supplier audits. And on the other hand, the pharmaceutical companies as well as the suppliers are frequently inspected by the authorities (both national and international inspectorates like the FDA) as a central element of supervision.
For the company, an inspection can have a decisive influence on the daily work and its economic future. A sound and thorough preparation is an essential key to successfully pass an inspection.
Target Group
This GMP Education Course is designed for all persons involved in preparing, managing and escorting audits and inspections.
Date & Technical Requirements
Date
Wednesday, 08 October 2025, 09.00h – 15.30h Thursday, 09 October 2025, 09.00h – 15.30h All times mentioned are CEST.
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-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.
Programme
Approach and Expectations of the Agencies
How inspectors are trained
Skills needed
Inspection preparation, strategy and tactics
Information transfer between inspectorates
What to expect, when being inspected in the near future
Observations - some practical examples
Preparing for a Regulatory Inspection
Team building
Gap analysis and action plan
Roles and responsibilities
Training of the staff
Function of moderator, escorts and experts
Case Study: Proactive Compliance and Inspection Management – it’s more than Self Inspection
How to increase inspection risk-awareness
Risk categorisation and ranking
Risk reduction prioritization
Reporting of the results to senior management
The MOCK-Inspection: Auditing your Company to prepare for international Inspections
Internal Audit and Mock-Inspection
Audit strategy
Roles and Responsibilities
Communication and co-operation
Sequence of preparation steps
Co-operation with customers and external auditors
Expectations from Inspectorates worldwide
Brazil (ANVISA)
Mexico (COFEPRIS)
Turkey (MOH)
Russia (FSI SID&GP)
Eurasian Economic Union (EAEU)
China (NMPA)
South Korea (MFDS)
Taiwan (TFDA)
The FDA Approach
The MRA between the U.S. and the EU and its consequences
The FDA Inspection System
What does FDA expect?
Responding to Audit and Inspection Findings
How to reply to report and observations
Dissent and Dispute
Proof of CAPA effectiveness
Ensuring that measures are implemented company-wide
What to do if a target date can not be achieved?
This training/webinar cannot be booked. Send us your inquiry by using the following contact form.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials
