Steve Hennigar - VP Validation
Steve Hennigar, P.Eng., brings strong analytical and communications skills to Quality & Compliance Services Inc. (Q&C)® Steve's presentation of his research thesis on the chemical modification of polymers was given a Neish award by Queen's University faculty and industry members. His positive outlook and proven problem-solving abilities allow Steve to complete projects and tasks efficiently without compromising quality.
Skills and Highlights
Validation
- Drafted HVAC IQ/OQ/PQ protocols.
- Performed Qualification (IQ/OQ) on Refrigerators, including temperature mapping of small size refrigerators and walk-in refrigerators using Kaye Validator®.
- Drafted and executed equipment IQ/OQ protocols for drug manufacturer.
- Drafted and executed analytical method validation protocols for drug product manufacturer.
Technical Writing
- Drafted and revised cleaning procedures and work instructions to meet GMP standards.
Consulting
- Revised more than 1,000 batch production records to assist with biologic manufacturer's backlog due to staffing transitions.
- Developed medical devices according to FDA requirements in GMP environment.
- Worked on project resulting in publication of "Determination of Alkoxyamine Concentrations in Nitroxyl Mediated Polymerization Products." Macromolecules, 35, 7628-7633 (2002).
- Worked on project resulting in publication of "Silica Agglomeration and Elastomer Reinforcement: Influence of Surface Modification." Plastics, Rubber and Composites, 32, 1-8 (2003).
Education
- Bachelor of Science, Chemical Engineering, Queen's University, Kingston, Ontario, 2002
Continuing Education, Career Development
- Analytical Method Validation, PSG
- cGMP Overview, Aventis Pasteur
- Design and Validation of Critical Utility Systems, U of T
- Fundamentals of Dissolution, PSG
- Fundamentals of GMP for Packaging Suppliers, Q&C
- GMP for Importers/Distributors, Q&C
- GMP Overview
- GMP Training, Aventis Pasteur
- Industrial Drug Legislation, Seneca College
- ISO Internal Auditor, Quality Management Institute (QMI)
- ISO Overview, Q&C
- Manufacturing Control in the Pharmaceutical Related Industries, U of T
- Practical Method Development & Validation for HPLC (Waters)
- Process & Cleaning Validation, U of T
- Review of Analytical Data
- SOP Writing
- Technical Writing Course, Q&C
- Validation Master Plan - Roadmap to Compliance, University of Toronto (U of T)
- WHMIS certification