President and Principal Consultant
Practical Solutions, LLC
(908) 464-3840

Frances Akelewicz is founder of Practical Solutions which emphasizes expert practical, business and cost based solutions for Quality Management, Risk Management, Regulatory Compliance and Regulatory Affairs for Pharmaceuticals, In-Vitro Diagnostics and Medical Devices. Our clients are supported with over 25 years of hands-on experience in global business practices and solutions. Practical Solutions provides training and consulting support throughout the United States, Canada and Europe.

Ms. Akelewicz has held positions such as VP Quality Systems, Worldwide Director of Quality Management and Regulatory Affairs, Corporate Director of Quality Systems, Associate Director of Pre-Clinical and Clinical Quality Assurance. Product experience includes biologicals, pharmaceuticals, combination products, IVDs, diagnostic catheters and implants.

Ms. Akelewicz holds Masters Degrees in business and Quality Management. Additionally, Ms. Akelewicz holds both black belt and champion black belts, ASQ certification in Quality Engineering, Quality Auditing, and Quality Management and holds membership in RAPS and AAMI. She is a RAB certified lead auditor. Ms. Akelewicz is currently an adjunct professor for Thomas Edison University in New Jersey is an instructor for ASQ on a national level in such topics as QE, DOE and Risk Management and has held positions at the ASQ local board level of treasurer, education chair and 2nd vice president.

Publications and committee memberships include AdvaMed’s Points to Consider for Design Controls, AAMI’s TIR on Ethylene Oxide Sterilization, Cost Management in Today’s Global Business Environment, panel member with FDA for Design Control.