Zielgruppe
This GMP Education Course is designed for all persons involved in preparing, managing and escorting audits and inspections.
Zielsetzung
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
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
Programm
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?
Weitere Informationen
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.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Mr Niklaus Thiel, +49 (0)6221 84 44 43, thiel@concept-heidelberg.de
Recording from 08/09 October 2025
Duration of the recording: approx. 7 h 50 min
Duration of the recording: approx. 7 h 50 min
.
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Regular Fee*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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