Using Qualification-Mapping & GAMP-based Risk Assessment for Software Validation
This webinar provides an overview of the regulations related to Good Distribution Practice, environmental mapping qualification, and software validation. With the forthcoming revisions to EU GMP Annex 15 in effect October 1, 2015, 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.
Presented by
Piritta Maunu,
Regulatory Expert, Life Science
Piritta Maunu is a Life Science Regulatory Expert in Vaisala. She has long experience in biotechnology, having worked in several quality management positions in R&D, quality and GMP production. Piritta holds a degree of M.Sc. (Cell Biology) and has studied teaching with a specialty in General Biology. In her role at Vaisala, she creates informational content for life science customers and provides application support to R&D teams creating solutions for monitoring critical environments. Additionally, she provides training through webinars and seminars to both internal groups at Vaisala and to industry contacts.
