Sue Mann
Sue Mann Consultancy
Referierende
Dr Zvonimir Majic
IATA Senior consultant for Healthcare, Croatia
Kane Edgeworth
Biomap
Alfred Hunt
Hunt Pharma Solutions
Applying GDP throughout the Pharmaceutical Supply Chain – Storage, Transport and Cold Chain
Zielgruppe
- Employees newly assigned to GDP-relevant roles within pharmaceutical distribution
- Supply chain and operations professionals seeking to strengthen their GDP understanding
- Quality Assurance personnel with new or expanded GDP responsibilities
- Newly established or growing GDP organisations and service providers
Zielsetzung
This Live Online Training Course provides a comprehensive overview of Good Distribution Practice (GDP) requirements applicable to the pharmaceutical supply chain, with a focus on storage, transportation and cold chain management of medicinal products within the European regulatory Framework.
Participants will gain a clear understanding of the legal and regulatory background of GDP, including its relationship to GMP, and learn how GDP requirements are interpreted by authorities during inspections. The training highlights current regulatory expectations, recent developments and emerging risk areas in pharmaceutical Distribution.
Programm
GDP Rules and Regulatory Framework
- What is Good Distribution Practice (GDP)?
- Relationship between GDP and GMP
- Overview of the EU GDP Guidelines
- Roles and responsibilities in the pharmaceutical supply chain
- Reference to additional guidance (e.g. ECA Roadmap to GDP)
Understanding the Pharmaceutical Supply Chain
- Selection of supply routes
- Key stakeholders and handover points
- Basic process mapping of a supply chain
- Fundamental QMS elements in distribution
- Where GDP risks commonly occur
GDP-Compliant Storage – Expectations and Common Pitfalls
- Storage types and temperature ranges
- Basic requirements for GDP-compliant storage facilities
- How to set up an adequate storage facility
- Introduction to temperature monitoring
- Typical storage-related inspection findings
- Common mistakes in warehouse operations
Introduction to Cold Chain Management
- Principles of cold chain management
- Monitoring versus validation
- Basic concepts of route qualification
- Data collection and basic evaluation principles
- Typical cold chain risks and failures
Best Practices in Transport and Logistics
- How to implement the requirements and stay efficient
- Managing 15-25 °C and 2-8 °C transportation
- Challenges that different modes of transportation introduce to pharmaceuticals
Case Study on Temperature Mapping
- Protocol preparation
- Seasonal variations
- Impact tests
- Results and reporting
Supply Chain Security
- Anti-counterfeiting strategies
- What the agencies can do
- What industry can do
- Compliance issues
Deviations & Excursions
- What is a deviation? What is a temperature excursion?
- Typical deviation scenarios in pharmaceutical distribution
- Immediate actions and escalation pathways
- Documentation and basic investigation principles
- Introduction to CAPA thinking
What to Expect During a GDP Inspection
- Purpose and structure of a GDP inspection
- Importance of careful planning for a GDP inspection
- Roles and responsibilities during an inspection
- Behaviour and communication during inspections
Data Integrity in GDP Activities
- Regulatory background
- ALCOA, ALCOA+ and ALCOA++ principles
- Data integrity deficiencies
- Data integrity - a growing GDP Focus
Import and Export
- Import and export from a GDP perspective
- Regulations impacting import and export (e.g. Annex 21, MRA)
- Political developments impacting import and export (e.g. Brexit, trade Embargos)
Weitere Informationen
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.
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.
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.
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.
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.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 03 Nov 2027, 09:00-17:30 h
Thu, 04 Nov 2027, 09:00-17:30 h
Thu, 04 Nov 2027, 09:00-17:30 h
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
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.
Tel.: +49 6221 8444-0
E-Mail: info@concept-heidelberg.de
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