Experience You Can Depend On

"Hands-on" with a solid background in Quality Systems (including certification to IS0 9000 and 13485), and Regulatory Affairs Management in the Medical Devices and Drugs Industries, with extensive experience in documentation, validation, auditing, training, technical service, and compliance to Quality and Regulatory Standards.

  • Quality Systems, ISO 9000 and 13485 development and implementation to certification, continuous improvement, and maintenance
  • Internal and Vendor Process and System Auditing
  • Far East Sourcing Quality System Development
  • Field Assurance including trending, reporting, and remedial/product recall actions
  • Potential Exposure to Bloodborne Pathogens
  • Ethylene Oxide Gas Sterilization, commissioning, decommissioning, and sub-contracting
  • Calibration
  • Drug GMP Compliance
  • Traceability, from manufacturing through to distribution
  • Documentation Control, QA/RA specification, policy and procedural development to implementation
  • Product and Process Validation, IQ/OQ, FMEA, FMECA, Root Cause, Defect Trending, CAPA
  • WHMIS
  • Regulatory transitioning, from submissions to cost recovery to licencing
  • Off-Label Use Guidance
  • Microbiological and Physico-Chemical Analysis
  • Budget Preparation
  • Training

Training and Background

  • Excelling as a Highly Effective Team Leader
  • Six Sigma, Executive Overview
  • Surviving the WorkWell Audit
  • Leadership Through Teambuilding
  • Cost of Quality
  • Root Cause Analysis
  • Health, Safety, and the Law
  • FDA Quality System Regulations (QSR)
  • ISO 9000:2000, ISO 13488/13485 from a CMDCAS perspective
  • Performance Management by Objectives
  • Diversity/Ethics
  • Design Control
  • Failure Modes and Effects Analysis
  • Statistical Concepts
  • Process Validation, Concepts & Applications
  • Project Management
  • Certificate Course in Management
  • Medical Devices, Drugs and Cosmetics, The Canadian Course for Regulatory Professionals
  • The Manager as Coach
  • Lead Assessor, ISO 9000 and 13488/13485 Quality Systems
  • Problem Solving with Statistical Techniques
  • Human Relations, Effective Supervision, The Art of Management
  • Food and Drug Technology including Microbiology; Analytical, Organic, and Physical Chemistry; Pharmacology; and Human Anatomy and Physiology