Bio

Creator of: CAPA EXCELLENCE BOOT CAMP 3-day boot camp style training Results Driven: • History of successful FDA/Notified Body inspections & negotiations; positive working relationships at FDA CDRH • 20 year history of leading successful remediation projects for multiple sites/businesses. • Delivered piece process & Quality Systems improvements resulting in clearing or avoidance of regulatory enforcement actions (e.g. Warning letters, 483 observations, etc.) • Proven track record for driving quality/compliance improvements across all levels and functions Team Oriented: • Successful record for building high-performing teams for Quality, Regulatory Compliance, and Regulatory Affairs Focused on Growth: • Creator of Best-in-Class CAPA and Internal Quality Auditor training programs • Worldwide CAPA Best Practice Leader for Danaher/Envista • Effectively drives harmonized, “best practice” processes across global medical device manufacturer E-Mail: james.tillmanRAC@yahoo.com -OR- james_tillman@qrc-qms.com Mobile: +1(717) 676-2286