Dr Daniel Müller
GMP Inspector
Referierende
Jonathan Riley
Takeda UK
Dr Torsten Schmidt-Bader
moveproTEC Compliance & Innovation Advisory
Alfred Hunt
Hunt Pharma Solutions
Highlights
- Inspector view: what authorities expect from the RP and the quality system
- RP in practice: self-inspections, validation, deviation management, and export/import
- From cold chain to security: managing different distribution scenarios
Zielgruppe
The course is of particular interest to Responsible Persons but also management and quality personnel from pharmaceutical companies, wholesalers, distributors and service providers involved in distribution of medicinal products.
Zielsetzung
The EU GDP Guidelines require wholesale distributors to appoint a Responsible Person (RP) for GDP. According to Chapter 2, RPs should fulfil their responsibilities personally and should be continuously contactable. The RP should have appropriate competence and experience, as well as knowledge of and training in GDP. He or she may delegate duties, but not responsibilities. The RP should carry out his or her duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
In this Live Online Training, the role and responsibilities of the Responsible Person for GDP will be highlighted and discussed.
Programm
The EU GDP Guidelines
- The counterfeit directive and the introduction of the EU GDP Guidelines
- GDP requirements for the pharmaceutical supply Chain
- Regulatory expectations for implementation
What is the RP and Wholesaling
- Qualification and experience requirements for RP
- The Role of RP in management of export & Import
- Annex 21: Importation of medicinal products
- Export & import to and from EU
Experiences from GMDP Inspections
- Inspections of the competent authorities
- Typical GDP inspection findings
Controlled Temperature Distribution
- How to manage cold chain products
- How to manage 15 - 25 °C requirements
- Air freight, sea freight, road transport and the last mile
GDP Audits and Self-Inspections
- How to plan audits and self-inspections
- Supplier / vendor audit and self inspection approaches
- Reporting deficiencies
- Examples of recent findings
Roles and Responsibilities of the RP
- Qualifications requirements for RPs
- Responsible Person vs. Qualified Person
- GDP vs. GMP
- Duties and Delegation
- How to discharge your duties
- Handling of returned and damaged goods
- Complaint Handling
Validation of Computerized Systems under GDP Regulation
- Validation requirements – regulatory overview
- GAMP oriented validation approach of GDP critical systems
Case Study: Validation of a new Warehouse and Material Management System
- Wholesaler in Germany
Workshop: Deviation Management
- During this workshop participants will learn and discuss how to ensure that the deviation system is being correctly used and implemented.
Security in the Supply Chain and Falsification
- Counterfeit / falsified pharmaceuticals – a real threat!
- What is pharma industry doing about it?
- Recent developments
- How can track & trace support anti-counterfeiting requirements
Weitere Informationen
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Fees (per delegate plus VAT)
European GDP Association Members EUR 1,890
ECA and European QP Association Members EUR 1,890
APIC Members EUR 1,990
Non- Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Contacts
For questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
For questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
For questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 28 April 2027, 09:00-17:30 h
Thu, 29 April 2027, 09:00-17:30 h
Thu, 29 April 2027, 09:00-17:30 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| GDP Association Member Discount*: | € 1890,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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