The Impact of 2015 Revisions to EU GMP Annex 15 on GDP

Good distribution practice revisions
Life Science

Learn how GDP changes will affect your operations

This 1-hour webinar provides an overview of the regulations related to Good Distribution Practice, environmental mapping qualification, and software validation. With the revisions to EU GMP Annex 15, all stakeholders must control the critical aspects of their operations through qualification and validation throughout a product’s lifecycle.

Because of globalization of manufacturing new GDP-compliant warehouses are needed around the world. All entities in the supply chain must show that temperature-sensitive products are being stored and transported appropriately.

This webinar will familiarize you with:

  • Temperature mapping qualification of storage areas
  • Using mapping studies to determine sensor location
  • Creating a monitoring plan (if it is worth mapping, it is worth monitoring)
  • Validation of environmental monitoring system software
  • How to apply a GAMP-based risk assessment framework to ensure compliance and product quality

You will be interested in this webinar if you store or distribute products in GxP regulated areas and want to learn how to ensure your environmental mapping qualification and monitoring systems are compliant with the changes to Annex 15.

Key Learning Objectives

  • Short overview of changes to regulations and guidance related to mapping and validation of the computerized systems
  • Five simple rules for mapping sensor placement in warehouses
  • Understand why monitoring systems are needed and what is required to validate a system
  • Use a GAMP-based Risk Assessment Framework

Audience

  • Facility & Operations Managers
  • Quality Assurance/Quality Control
  • Logistics & Distribution Managers
  • Regulatory Compliance
  • Laboratory Managers
  • Validation/Qualification professionals

 

By submitting this form you acknowledge Vaisala’s Privacy Policy
You can manage your preferences here

Speaker

Piritta Maunu

Piritta Maunu

Life Science Regulatory Compliance and Industry Expert​

Piritta Maunu has 15 years of experience in biotechnology, having worked in several quality management positions. Maunu holds a degree of M.Sc. (Cell Biology) and is certified to teach with a specialty in General Biology, both degrees from the University of Jyväskylä, Finland. In her role at Vaisala, she supports the sales department, assists the quality department with audits, creates educational content for life science customers, and provides application support to R&D teams creating solutions for monitoring critical environments.