Presenters: Robert J. Finamore, Director of Validation Services, QPharma, Inc.
Organizations that fall within the enforcement domain of the FDA must comply with record keeping requirements for a host of regulated information. This includes records that are maintained as part of a Quality Management System (QMS), such as Complaints, Audits and Corrective and Preventive Actions (CAPA).
The use of automated systems results in great advantages for the generation, tracking, maintenance, and analysis of such data; however, the use of these eletronic systems opens up an array of new compliance issues and requirements. One of these key requirements is to perform validation of automated system to ensure they operate in accordance with their documented requirements and user expectations. Validation is not meant as a tool to debug the system, but is used to provide objective evidence that the system is under control and working within defined specifications.
During this webinar, Mr. Finamore will:
- introduce individuals to basic requirements and the fundamentals of executing a validation effort for an automated Quality Management System.
- assert that validation is more than just simply testing a system.
- cover the full validation lifecycle and documentation suite from the planning and requirements stage through to ongoing operation and maintenance of the automated system.
- describe a methodology that focuses on ways to make the validation process more efficient while maintaining a full level of compliance.
At the conclusion of the presentation you will understand:
- the "what" and "why" of validation for quality management systems.
- keys to executing an efficient and successful validation effort.
- how to use risk based approaches to focus validation on critical functionality.
- ways to leverage different kinds of vendor supplied compliance documentation.
- the additional controls required to maintain the system in a validated state.
Robert J. Finamore serves as the Director of Validation Services for QPharma, Inc., a regulatory compliance consulting firm based in Morristown, NJ. He has been a leader at QPharma over the past 10 years in the management and execution of over 100 regulatory compliance projects, and is a recognized expert in computer system validation and 21 CFR Part 11 compliance. He currently oversees the professional services group, which executes regulatory compliance projects in the fields of validation, quality systems, medical device consulting, training, and auditing for life science clients.