Colleen Woodworth

I am a highly capable researcher, writer, and presenter who excels at critical decision making.  Independence and innovation, integrated with common sense and practicality are the hallmarks of my professional career. 

I have single handedly implemented an entire Quality Management System including an internal audit and CAPA program, introduced change control and vendor management to our software development lifecycle, and introduced training and guidance on inspection readiness.  My legal skills have been highly transferable to the regulatory compliance and quality assurance arena, while prior experience with legal case work has evolved into innate ability and confidence to consult and steer an entire organization towards proper legal trends and best practices.

• FDA and clinical trial regulations and best practices
• Quality Management Systems
• Risk management
• Privacy and data security
• Computer systems validation 
• Internal auditing and CAPA management
• 501(c)3 organizations and related tax exemption issues
• ERISA, labor and employment law