Dr Afshin Hosseiny, Chair of the European GDP Association
The globalisation of the pharmaceutical supply chain has created new challenges for the manufacture and supply of medicinal products in various markets. Directives, Guides, Guidelines and initiatives from various regulatory bodies lead the way in this development and define expectations and requirements, where Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) are closely linked. In 2013 the revised new “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” were published. Chapter 2 “Personnel” defines the qualification requirements, tasks and responsibilities of all staff and the Responsible Person (RP).
The requirements to be met include the following:
- The responsibility, role and interrelationships of all personnel should be clearly defined.
- Responsibilities and roles of employees working in key positions should be defined in written job descriptions, including arrangements for deputy duties.
- All employees involved in the distribution of medicinal products need to be trained in order to comply with the requirements defined in the GDP Guidelines.
The webinar is aimed at coworkers and high-level personnel from the following industries:
- Pharmaceutical manufacturers (e.g. logistics and QA),
- Drug wholesaler,
- Logistics companies,
- External warehouses,
- Further service providers offering services for the distribution of pharmaceuticals.
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.
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.
This webinar aims to give participants a comprehensive yet compact overview on the various responsibilities at GDP. The following Topics will be covered:
- What is GDP
- What activities are classed as GDP relevant
- Who is involved in GDP activities
- Who is responsible for these activities
- Is there any shared responsibility (GDP & GMP)
- What to do when things go wrong
- Who should deal with problems
- Who should be told
Recording from 18.01.2022
Duration of the recording: approx 1.5 h