Based in Penfield, NY 14526
MECHANICAL ENGINEERING, GxP Compliance, Product Realization, Design Control
Medical Device | Combination Pharmaceutical Products - FDA and EU
About Us
Our Services
As a GxP Compliance, Product Realization, and Design Control professional I will look at your business process including product development product realization process. I will assess your quality system as well as how you manage your quality system. It is important to perform a gap assessment that will identify areas of opportunity in order to have your approach to the regulations and customer satisfaction less challenging.
Change sometimes requires thorough planning and an experienced eye to navigate the hills and valleys along transition road. I provide solutions when you are faced with the need to manage cultural change across your organization and in relations to your partners, suppliers, and CMOs.
Our Projects
Enqual provides guidance on strategies to make your medical and pharmaceutical device business processes and product realization ready for growth changes influenced by adoption of additional capabilities and increased oversight by regulatory agencies. Enqual can provide training to ensure opportunities to leverage your existing methods are implemented.
SUBJECT MATTER EXPERT
Statistical Analysis
Design of Experiments
Root Cause Analysis
Process Mapping and Lean Manufacturing
USP Purified Water | USP Water for Injection
About Us
Over 28 Years Experience
Product Development & Engineering
Quality System Support
Project Management
What sets me apart is my foundation at a start up company and then in the high potential employee programs of Corning Incorporated and Bausch & Lomb of the 1990s.
My career was shaped to have a strong knowledge base in many areas of the product development and manufacturing process. Along with my ability to learn things quickly I have grown into a valuable asset in the areas of new product development, quality engineering, human factors, and regulations.