Katja Kotter
Vetter Pharma-Fertigung
Referierende
Dr. Ralf Schreiner
QProgress
Alexander Kammerlocher
Regierungspräsidium Tübingen
Ciara Clarke
Sumac Works
All participants receive a Checklist for FDA Inspection Preparation
Zielgruppe
Personnel involved in audit and inspection preparation, management and hosting.
Zielsetzung
You will gain a clear understanding of the purpose and organisation of regulatory inspections and learn how to prepare your company for inspections and customer audits. You will also discover how to manage these activities effectively and maximise the likelihood of a positive outcome.
You will gain practical insights into:
You will gain practical insights into:
- What inspectors are looking for
- Preparing for and managing inspections successfully
- Conducting a mock inspection
- The latest inspection trends
Real-world examples from global inspections will help you understand what inspectors expect in practice.
Programm
Background
GMP audits and inspections play a fundamental role in quality management within the pharmaceutical industry. Pharmaceutical companies must conduct audits of their suppliers, while both companies and suppliers are regularly inspected by national and international regulatory authorities, including the FDA.
The outcome of an inspection can significantly affect a company’s operations and commercial prospects. Comprehensive and effective preparation is therefore essential for successfully managing an inspection and achieving a positive outcome.
GMP audits and inspections play a fundamental role in quality management within the pharmaceutical industry. Pharmaceutical companies must conduct audits of their suppliers, while both companies and suppliers are regularly inspected by national and international regulatory authorities, including the FDA.
The outcome of an inspection can significantly affect a company’s operations and commercial prospects. Comprehensive and effective preparation is therefore essential for successfully managing an inspection and achieving a positive outcome.
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
Technical Requirements
We use Webex for our live online training courses. 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.
Fees (per delegate, plus VAT)
ECA Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice.
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
Question regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Mr Niklaus Thiel, +49 6221 84 44-43, thiel@concept-heidelberg.de
We use Webex for our live online training courses. 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.
Fees (per delegate, plus VAT)
ECA Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice.
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
Question regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Mr Niklaus Thiel, +49 6221 84 44-43, thiel@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 1 Dec 2027, 09:00–15:30 h
Thu, 2 Dec 2027, 09:00–15:30 h
All times mentioned are CET.
Thu, 2 Dec 2027, 09:00–15:30 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 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
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
