Kristi Musgrave is a Quality Systems professional with over 17 years of experience in FDA regulated industries including Medical Devices, Drugs, Biologics, and Dietary Supplements.
She has proven ability in leading organizations in consent decree remediation activities and global rollouts of world class quality systems.
Kristi has extensive experience in developing quality management systems that comply with 21 CFR 210/211, 21 CFR 820, 21 CFR 111, ISO 13485, and ISO 9001.
She specializes in designing compliant, efficient, and effective quality systems by developing streamlined user friendly documents, creating engaging and effective instructor-led and web-based training content, and providing ongoing performance support and coaching.
She has successfully accomplished:
- Developing/redesigning CAPA systems to include: clear procedures and processes, robust root cause analysis, appropriate selection of corrective actions and verification of action effectiveness.
- Creating “best practice” training programs that focus on identifying training needs and assembling role based training curriculum with clear training objectives, and engaging training content.
- Preparing for regulatory and notified body inspections by: completing gap analysis, creating remediation plans, executing implementation plans, and providing support during inspections.
- Writing responses to findings and warning letters and leading remediation efforts.
Her role as Quality Operations Manager at Baxter BioScience included developing the facility’s first Quality Operations Department which resulted in significant and measurable improvements in manufacturing.
Kristi received her Bachelor of Science in Biology, Specialization in Microbiology from Oakland University.