Delivering Manufacturing Projects in a Risk-based World: The New Regulatory Paradigm and its Impact on Facility Design ( WEBREGPAR )
Description:
The new FDA Guidance for Industry on Process Validation states that “activities undertaken to demonstrate utilities and pieces of equipment are suitable for their intended use and perform properly is referred to as qualification.” Today’s regulatory expectations for delivering facilities under a risk-based approach must focus on the intended use of the facility related to the product(s) being manufactured. This webinar discusses concepts of Good Engineering Practice (GEP) and Quality by Design (QbD) and also identify synergies with the new ASTM E2500 standard “Standard Guide for the Design, Specification, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.” These new approaches for working under a risk-focused Quality Management System will introduce new concepts to project teams and change the way proven engineering/project management systems are implemented and reviewed by the FDA.
Objectives:
At the conclusion of this session, participants will be able to:
Learning Catalog