Dr Afshin Hosseiny
ECA
Referierende
Shortcuts: compact learning units of 1–3 hours – perfect for a quick overview or a focused deep dive into a specific topic. Book online, receive access within minutes and benefit from 7 days of on-demand availability, giving you maximum flexibility in your day-to-day work.
Compact. Flexible. Immediately available.
Discover GMP & GDP ShortcutsZielgruppe
The shortcut 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.
Zielsetzung
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 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.
Programm
This shortcut 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
Weitere Informationen
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
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
Duration of the shortcut: 1h 30m
Recorded in January 2022
Please note:
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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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