"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
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 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
Who should attend:
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.
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
Watch this short video to learn more about what Gate2GMP® offers »
Bring this course in-house?
Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?
If so, running the course in-house is probably the best and most cost effective solution.
14 April 2020
10.00 - 11.30 (120 min) CET (Central European Time)
Price (excl. local VAT):
250 Euro for the first participant.
115 Euro 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.
You need access to a computer, tablet or mobile phone with internet connection (preferably min 700kB/s) and audio capabilities (speakers or headphones).
We are using the easy-to-use application "GoToWebinar".
See more about how to join a session and the system requirements here »
Instructions will be attached to your order confirmation.
Cancellation policy for webinars:
Cancellations received less than 7 days before the webinar will be charged 50% of the course fee.
Cancellations received less than 24h before the webinar will be charged 100% of the course fee.
If you for any reason is unable to attend, substitution is always possible and preferred. All cancellations and/or substitutions must have been communicated with and confirmed by us.
In case of failure to cancel before the course, the course fee will be charged in full.
Cancellation of webinars:
Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value.