CSI: Calibration — Solving Quality Mysteries in Medical Device & Pharma
- Start Date : 9 February, 2027
- Start Time : 8:00am
- End Date : 9 February, 2027
- End Time : 12:00pm
- Address : Harbor Rm, N Tower
No Schedule
Abstract
Nonconformances, out-of-tolerance (OOT) results, and calibration anomalies show up in every GMP-regulated facility — but too many investigations turn into paperwork exercises instead of real problem-solving. This half-day, hands-on tutorial reframes investigation writing as detective work: participants take on the role of “quality investigators,” working through interactive case studies and simulated calibration/OOT and Nonconformance scenarios to practice scoping impact, applying root cause tools (5 Why, fishbone, fault tree), and building conclusions that hold up under audit and FDA scrutiny. Expect small-group exercises, live problem-solving, and practical takeaways (templates and checklists) attendees can apply immediately. Designed for quality engineers, calibration/metrology technicians, validation specialists, and QA reviewers with some hands-on exposure to deviation/investigation systems. Learning level: Intermediate. Format: Half-day.
Emily Purchase
I love helping people live longer, stronger lives through the work I do behind the scenes. My passion lies in ensuring that every product meets the highest standards of quality and safety. Whether it's through leading technical investigations, advising on compliance matters, or summarizing complex technical information, my focus is on making sure patients receive the best care possible. Driven by a commitment to excellence, I thrive in environments that demand precise communication and continuous improvement, ensuring that every step of the process contributes to healthier outcomes for patients around the world. With over 26 years of experience in the Pharmaceutical and Biopharmaceutical sectors, I specialize in Quality, Compliance, and Regulatory leadership. I have a proven track record of leading global Quality Management Systems, overseeing regulatory inspections, and managing complex compliance environments. My expertise spans Good Manufacturing Practices (GMP), FDA Warning Letter remediation, and operational readiness, with a strong focus on continuous improvement and patient safety. I am passionate about fostering collaboration, mentoring teams, and driving innovation in quality processes.