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Medical Device equipment

How to Qualify your suppliers in compliance with GMP

An overview of GMP requirements for both material and service suppliers

WEBINAR - 11 November

Get the essentials of supplier control requirements in GMP during this informative webinar. Both EU GMP requirements and US FDA requirements will be covered.

Don't miss the independent continuation of this webinar: "Starting materials – the GMP essentials" (18 Nov)


Course description:

The quality of the final product is always heavily depending on the quality of its components. Also our processes within the quality system may be impacted by the quality level of our service suppliers. To ensure that the patient using medicinal products always can trust that every dose has the right quality, one aspect of GMP requirements is related to the processes to ensure adequate supplier control.

This webinar will summarise the requirements and discuss practical application and how to handle risks related to suppliers. The requirement to establish formal agreements with your suppliers will also be covered.

Course outline:

  • Formal GMP requirement related to Suppliers and Outsourcing
  • Supplier evaluation – risk based approaches
  • Quality Agreement , Technical agreements and other types of contracts
  • Supplier controls – maintaining a compliant state
  • FDA Inspection and compliance trends

Learning objectives:

  • Understand the different GMP requirements related to material and service suppliers
  • Discuss different models for supplier evaluation
  • Understand the basis for the Technical/Quality Contract that has to be documented
  • Get insight in how supplier controls can be leveraged based on risk

Who should attend:

This course is intended for professionals who are responsible for Supplier evaluation and control from a GMP perspective. Production and Quality professionals will benefit by learning the potential challenges so that appropriate actions can be taken.

Prerequisites

  • At least Basic GMP Knowledge
  • Some practical experience with supplier controls is beneficial

 

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Course facts

Course no:
5824
Industry:
Pharmaceuticals

Level:
Intermediate
CS/GMP region:
EU/US

Language:
English
Instructor:

Anna Lundén

Date:
11 November 2020, Online


Time:
10.00 - 11.30 CET (Central European Time)

Price (excl. local VAT):
250 Euro
Course handouts (PDF) and certificate of attendance is included.


Discounts:
For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.


Equipment needed:
You need access to a computer, tablet or mobile phone with internet connection (preferably min 1MBit/s) and audio capabilities (speakers or headphones).
We are using the easy-to-use applications "GoToWebinar" and "GoToMeeting".
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.