Performed a “current state” assessment of device and combination product development capabilities to understand strengths and gaps. Installed a combination product and device PDP, including business governance, and worked with the quality organization to upgrade current procedures to address combination product requirements.

Conducted a rapid implementation workshop for a generic drug manufacturer, to integrate design controls and risk management into their quality system to meet combination product requirements. Company was able to implement the necessary SOPs in record time and is currently building internal talent to support development teams. Action for Results continues to provide training design and train-the-trainer delivery support and consultation.

As part of a device PDP roll-out plan, discovered that the client company had several different quality systems which did not cover design controls consistently. Led a global, company-wide, design controls harmonization effort which included working with the internal SMEs to drive the harmonization.