Ashwin Lahori Email & Phone Number

Florida, United States

Weston, Florida, United States

Sunrise, Florida, United States

• Managed clinical trial sites, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines, including adherence to 21 CFR Parts 50, 54, 56, and 812.• Facilitated meetings with parties including internal and external teams, company executives, and the FDA to ensure clear communication of project goals, timelines, and responsibilities.• Developed, managed, and maintained comprehensive documents including protocols, Case Report Forms… Show more • Managed clinical trial sites, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines, including adherence to 21 CFR Parts 50, 54, 56, and 812.• Facilitated meetings with parties including internal and external teams, company executives, and the FDA to ensure clear communication of project goals, timelines, and responsibilities.• Developed, managed, and maintained comprehensive documents including protocols, Case Report Forms (CRF), Non-Compliance Reports (NCR), Corrective and Preventative Action (CAPA), Instructions for Use (IFU), Standard Operating Procedures (SOP), and complaints.• Led regulatory strategy development and FDA submissions, including Investigational Device Exceptions (IDE), Humanitarian Device Exceptions (HDE), annual reports, adverse events, and manufacturing changes.• Trained and certified new investigators on ARTISAN investigational plans and products, including good clinical practice, protocol changes, and adverse events.• Coordinated, traveled to, and conducted clinical site audits to ensure adherence to regulatory standards and protocols, particularly focusing on 21 CFR Parts 50, 54, 56, and 812.• Conducted hands-on workshops and simulation exercises, allowing surgeons to gain practical experience with RingJect in a controlled environment.• Proficient in using Clinical Trial Management Systems (CTMS) for planning and tracking trials, Electronic Data Capture (EDC) systems for accurate and efficient data entry, and maintaining comprehensive Trial Master Files (TMF) for regulatory compliance.• Oversaw quality management responsibilities including complaint handling, maintaining quality standards per ISO 13485, post-market quality surveillance, Root Cause Analysis (RCA), and product analysis.• Troubleshot and provided support for day-to-day commercial issues, optimized existing packaging processes, and developed effective inventory process instructions. Show less

Miami, Florida, United States