How to Qualify your Suppliers in Compliance with GMP

An overview of GMP requirements for both material and service suppliers

WEBINAR

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”

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

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

#5824

IndustryPharmaceuticals
LanguageEnglish
LevelIntermediate
RegionEU/US
YOUR INSTRUCTOR(S)​

Anna Lundén

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