Judy Carmody Ph D Executive Quality Consultant

Leveraging exceptional professional and field expertise in operations and quality, I provide thought leadership and guidance to senior and executive management and develop and build strategic relationships at all levels of management to achieve corporate goals. Selected Accomplishments: ◆ Created the Voluntary Quality Assurance VQA)® approach for building a VQA® culture, and working closely with my clients, successfully implement the approach to realize more compliant functional teams and higher quality, safer products. ◆ Recognized as a Distinguished Speaker for 2018-2021 by the Society of Quality Assurance for achieving a top rating as an expert on a wide variety of Quality Assurance topics and demonstrating skill in presenting to audiences in a meaningful and engaging way. ◆ Create and present courses at conferences and client facilities on topics including: » 21 CFR Part 11: Electronic Records and Electronic Signatures » Data Integrity » Stability » Investigations and CAPAs » Analytical Method Validation » Good Manufacturing Practices (cGMPs) » Risk Assessments » Training » ICH E6(R2) Compliance: Employing GMP Techniques in GCP for More Robust, Compliant Clinical Trials Offering expertise in: ◆ Acquisition or Investment Due Diligence ◆ Operational Strategic Planning ◆ Building Operation and Quality Teams ◆ Building Corporate Quality Cultures ◆ Building Quality, Clinical, CMC, Materials Management/Supply Chain, IT and Laboratory Systems ◆ Vendor Selection and Management ◆ Inspection Readiness ◆ GMP/GLP/GCP compliance ◆ Auditing ◆ Gap Analyses ◆ Event Investigations/CAPAs ◆ Validation (including process, computerized systems, analytical methods, cleaning, manufacturing equipment) ◆ Equipment calibration/maintenance programs ◆ Method validation/method transfer ◆ Training and developing training programs ◆ Materials management Please visit the website and click on "Videos" to learn more about my scientific approach to Quality and Quality Systems.