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

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

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Speaker

Liftup: Contact Card | Jul 18, 2017

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.