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A Practical, Resource Effective Approach to Risk Management: Common and Customized Tools
December 7, 2022 @ 8:00 am - 9:30 am
A Practical, Resource Effective Approach to Risk Management: Common and Customized Tools
1.5 CE Contact Hour
Location: ZOOM Webinar
Speaker: Manuel Pestana da Silva, QRM Specialist, 4TE – A ValGenesis Company
Moderators: Tommi Papson, OCRA Past President
During this presentation we are joined by Manuel Pestana da Silva, QRM Specialist, 4TE – A ValGenesis Company.
We will focus on the foundations of Quality Risk Management, which stretch across the process, the responsibilities, the regulatory background, and others. The implementation of a robust QRM process into the pharmaceutical quality systems is of high importance, as to maximize productivity and safety. The application of QRM principles throughout the lifecycle will be described, considering the necessary level of formality associated with the existing QRM tools, alongside practical examples of the of the QRM tools in different scenarios. These examples will focus on risk management workflows for products and suppliers, with descriptions for the rankings that support the risk management exercise.
Manuel Pestana da Silva
Quality Risk Management Specialist at 4TE
Manuel is currently working as a Quality Risk Management Specialist at 4TE, helping and managing the implementation of different QRM approaches on several pharmaceutical and biopharmaceutical companies around the globe. In addition, he supports the development and validation of the digital solutions that 4TE provides to its clients, as well as accompanying them throughout the whole internal implementation process.
As for academic background, he has a Masters degree in Biological Engineering by the University of Lisbon, Portugal. Manuel can be reached at mps@4tuneengineering.com
Moderator:
Tommi Papson, OCRA Past President
Regulatory Consulting Group
papson.rcg@gmail.com
COSTS:
OCRA Members and Non-OCRA Members: FREE
Certificates of attendance will be emailed after the event.
Questions? Contact program@ocra-online.org
OCRA’s non-profit Federal Tax ID# 33-0630455
Registration should be made in the name to be used on the certificate of completion
ValGenesis, Inc. is the creator of an innovative software platform that is a foundation for managing compliance-based validation activities in life sciences companies. ValGenesis VLMS is the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements.
