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.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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