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GMP responsibilities for MAH – new draft from EMA

Key2Compliance®
1 dag
Webinar
Online
250 EUR ekskl. moms

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gmp

GMP responsibilities for MAH – new draft from EMA

Joint GMP responsibilities between the Marketing Authorisation Holder and the manufacturer.

In January 2020, EMA published a draft with the title "Reflection paper on Good Manufacturing Practice (GMP) and Marketing Authorisation Holders". This document shed light on several scenarios where the interface between the manufacturer and the MA Holder, in accordance to the EMA, needs to be better specified and documented, normally in the form of a contract.

This course is an online webinar.


Course description

This webinar take you through the different areas and give you a good overview of the references that already exists to govern responsibilities between the manufacturer of the medicinal product and the MA Holder.

Topics covered from the Concept paper:

  • Outsourcing and technical agreements
  • Auditing and qualification
  • Communication with manufacturing sites
  • Product Quality Reviews
  • Quality defects, Complaints and recalls
  • Maintenance of supply
  • Continual improvement

When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.

Målgruppe

This webinar is intended for Quality Assurance, Regulatory Affairs and Production professionals that deals with GMP aspects of the relationship between the manufacturer and the MA holder, regardless if this is different organisations or within a group of companies.

Pris

The course price is 250 Euro excl. VAT for the first participant.
115 Euro excl. VAT for the following participants on the same registration and invoice.
Course handouts (PDF) and certificate of attendance is included.


For larger groups, please contact us for an offer.

Om udbyderen

Key2Compliance®

Key2Compliance® er et uafhængigt internationalt netværk, der tilbyder kurser og produkter til forskellige funktioner i Life Science-branchen, fra udvikling til marked med hensyn til kvalitetssystemer og GMP-overholdelse.  Ved at hjælpe organisationer med at imødekomme GMP / QS-forventninger, forbedre arbejdsstyrkens viden...


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Telefon: +46 (0)8 544 811 60

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