The Responsible Person for Good Distribution Practice (GDP) - Online Training Recording
Course No. 19083A
Speakers
Dr Afshin Hosseiny
ECA
Dr. Daniel Müller
GMP Inspector
Laura Ribeiro
OCP
Alfred Hunt
Hunt Pharma Solutions
Objectives
The EU GDP Guidelines require that wholesale distributors have to appoint a Responsible Person (RP) for GDP. There has been a lot of discussion about the duties of the RP. Therefore, the ECA Foundation’s GDP Working Group has developed this training course. In this course, the role and responsibilities of the Responsible Person for GDP will be highlighted and discussed.
Background
In 2013 the ‘Guidelines on Good Distribution Practice of Medicinal Products for Human Use’ were published. The Guidelines were revised to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union. Moreover, it should take into account the amendments to the Community Code which have been introduced with Directive 2011/62/EU of the European Parliament and of the Council. It is amending Directive 2001/83/EC on the Community code relating to medicinal products for human use with regard to preventing falsified medicinal products to enter the legal supply chain.
In Chapter 2 “Personnel”, tasks and responsibilities of the RP are defined. RPs should fulfil their responsibilities personally and should be continuously contactable. The RP may delegate duties but not responsibilities. General requirements like organisational chart, job descriptions and tr
Target Group
This Live Online Training 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 for human use.
Technical Details
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 presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
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
Roles and Responsibilities of the Responsible Person
Qualifications requirements for RPs
Duties and Delegation
How to discharge your duties
What the Responsible Person (RP) needs to know about batch release
Experiences from GMDP Inspections
Inspections of the competent authorities
Typical GDP inspection findings
Management of Export and Import
Annex 21: Importation of medicinal products
What does batch release mean?
Export and import to and from UK
The Roles and Responsibilities of Wholesalers and 3PL Service Providers
Services offered
How to manage different clients and their requirements
Pick and pack – best practices
How to stay in compliance
GDP Audits
How to plan the audit
Approach to GDP audits
Reporting deficiencies
Examples of recent audit findings
What You Need to Know about 3PL Service Providers
Co-operation
How 3PL service providers are organised
Contracts and qualification
Case Study: Management of a GMP Warehouse and Distribution of Medicinal Products with a 3PL-Approach
Outsourcing in Pharma Logistics – current trends & benefits
Determining the scope of Outsourcing
Processes, roles & responsibilities
Monitoring of critical data
Reporting of the performance & controlling of the 3PL
Roles and Responsibilities of an RP and a QP
Responsible Person vs. Qualified Person
GDP vs. GMP
Product finishing activities
Product diversions
Handling of returned and damaged goods
Complaint Handling
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
Security in the Supply Chain – What is Expected and How Industry is Approaching it
FMD and its role in supply security
How can track and trace improve supply chain
What is available and how to implement
Recording from 30/31 March 2022 Duration of the recording: about 10 h.
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager" Learn more
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