Sessions
Recall Readiness Enforcement trends and what CDRH is looking at today
12:15 PM - 1:00 PM Mon
Ancy Johnson supports the global life sciences industry by providing comprehensive assistance in developing and implementing solutions to address their regulatory and quality compliance requirements. With over 8 years of consulting experience in various functions within the global life sciences sector, Ms. Johnson has acquired a deep understanding of regulatory frameworks and industry standards.
Ms. Johnson has successfully led and supported numerous engagements, including acting as the interim head of U.S Vigilance for a medical device organization where she helped stand up a Vigilance department and helped develop a new FDA-compliant, harmonized complaint handling process and standard operating procedure for all U.S. sites with the capability of global alignment and assisted the client in closing 1,000+ complaints within 30 days while maintaining incoming volumes. In this role she assumed oversight of 11 active recalls and her and her team worked to implement a robust communication cascade plan, performance analytics and dashboards, and developed a client-tailored recall management playbook.
Ms. Johnson has also helped companies in the life sciences industry formulate go-to-market strategies, implement plans for diverse systems, benchmark reporting on various topics across the Life Sciences industry, formulation of regulatory and compliance frameworks, conducting gap assessments for critical areas such as risk assessments, change implementations, and FDA submissions (De Novo and PMA).
With her extensive regulatory compliance experience, both domestically and internationally, Ancy Johnson demonstrates a comprehensive understanding of various regulatory frameworks, including GxP, ISO, and FDA regulations. Her experience shows a strong track record of collaborating with cross-functional teams to deliver high-quality products in a regulated environment. Her in-depth knowledge of these standards enables her to guide organizations effectively in achieving and maintaining compliance with regulatory requirements.