Konopa Konsulting offers the deep industry knowledge necessary to navigate FDA regulatory compliance, process improvement, project mangement, and strategic planning relating to packaging of foods, dietary suppliments, pharmacueticals and medical devices.
Diane Konopa is an ASQ certified cGMP professional and holds a MS in Medical Biotechnology from the University of Illinois at Chicago as well as a BA in Psychology, BS in Biology and a minor in Chemistry form Northern Illinois University.
Before starting her consulting business, Diane held multiple positions during her 23 year career in the pharmaceutical industry. Experiences ranged from Microbiology Laboratory Supervisor, Manager of Quality Control - Validations and Calibration, Vice-President of Quality Assurance and eventually Director of Quality control.
Highlighted accomplishments include:
Design and implementation of the Integrated Batch Record improving customer satisfaction, reducing documentation entries by 60%, reducing average batch record review/release time by 50%, and increased batch record “right the first time” from 80% to 92% thereby saving the company an estimated $250,000 in the first year.
Designed and and oversaw the construction of an Analytical Laboratory which eliminated the dependence on outside services and introduced a new revenue stream for the company.
Implemented a Risk Management Program for Supplier Management saving $40,000 in travel expenditures in the first year.
Designed and implemented a New Product Safety Assessment form based on Safebridge criteria reducing the risk of cross contamination for packaged products while reducing occupational exposure.
Streamlined warehouse receiving procedures and forms simplifying training, reducing deviations and reducing time spent maintaining work instructions and forms.
Implemented Holistic Change Control Procedure and Form in SmartCAPA improving the tracking of open change controls reducing the number of customer audit observations regarding the change control process by 80% with zero regulatory observations.
Led various teams in the implementation of software such as Pilgrim SmartDOC and SmartCAPA.