Frances C. Akelewicz, CQE, CQA

Frances C. Akelewicz is president and principal consultant for PRACTICAL SOLUTIONS. Ms. Akelewicz has spent her 20+ year career in both the global pharmaceutical and medical device industries. Ms. Akelewicz provides training and consulting services for organizations throughout the United States, Canada, and Europe. She has held positions such as Worldwide Director of Quality Management and Regulatory Affairs, Corporate Director of Quality Systems, Associate Director of Pre-clinical Quality Assurance. Ms. Akelewicz processing background includes aseptic processing, liquid, powder and viscous fills. Product types include pharmaceuticals, biologicals, LVP and SVP, lyophilized product and solid dose. Medical device products include implants, diagnostic catheters, and IVDs.

During her tenure, Ms. Akelewicz has participated in submissions for the pharmaceutical and device industries which included ANDA, NDA, PMA, and 510k. Additionally, she has managed major product launches, facility qualification projects, crisis management projects and development of a comprehensive Quality program for R&D. Ms. Akelewicz has participated in both industry and FDA panels related to a diversity of topics such as design control and product submissions.

Specific to design control, Ms. Akelewicz has actively participated in the development of industry education and deployment of design control through FDA/industry seminar roll outs and is currently participating in the development of a Points to Consider document from an industry trade group.

Ms. Akelewicz holds a M.S. in Quality Management, an MBA and a B.S. in Biology. Additionally, Ms. Akelewicz holds both black belt and champion black belts. She currently is an adjunct professor for Thomas Edison University in New Jersey. National certifications include ASQ's certified Quality Engineer and Quality Auditor. Ms. Akelewicz is active in ASQ and has held positions at the local board level of treasurer, education chair and 2 nd vice president.

Examples of her corporate clients have included British Oxygen Corporation, Becton Dickinson, Johnson & Johnson, Arista Laboratories, North American Sterilization and Packaging, American Cardiovascular Research Institute, Akorn Pharmaceuticals, Biopure and GE Medical.