Streamlining Change Control – Implementing a risk-based change management process
Avsnitt

Streamlining Change Control – Implementing a risk-based change management process

This week, Stacey welcomes back Ivan Soto, to discuss strategies that enable the implementation of a risk-based change management process. Utilizing a risk-based lifecycle approach to manufacturing allows us to identify, analyze, understand, manage and report any risk, or potential risk throughout the lifecycle. When it comes to change control, it can be much more challenging to apply risk-based methods.

Ivan Soto is the Director CQV at Emergent BioSolutions, he is responsible for leading the commissioning, qualification, and validation activities at the Canton Massachusetts manufacturing facility. He has been in the industry for over 20 years and held several technical and management positions at different biotech and pharmaceutical companies in the areas of Validation, IT Compliance, Quality Control, and Quality Assurance, Manufacturing, and Business Strategy. Ivan is also a contributing editor for the Journal of GxP Compliance and Journal of Validation Technology. He has a B.S. in Chemistry from the Pontifical Catholic University of Puerto Rico.

Disclaimer: The views expressed in this podcast are those of the guest alone and do not represent the views of Emergent BioSolutions.

Resources:

https://www.ivtnetwork.com/article/streamlining-change-control-implementing-risk-based-change-management-process

https://www.fda.gov/media/85281/download

https://picscheme.org/docview/3817

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

Podden och tillhörande omslagsbild på den här sidan tillhör IVT Network. Innehållet i podden är skapat av IVT Network och inte av, eller tillsammans med, Poddtoppen.