1. National Union Management Consultation Committee - Drug Manufacturing Inspection Transformation
May 16, 2017
Regulatory Operations and Regions Branch

2. Agenda: Program Overview and Context Inspection Transformation Mandate
Inspector Engagement
Key Initiatives

3. Drug Establishment Inspections – FY 2016/17
Program Overview
The Drug GMP Program is a national program responsible for inspecting drug establishments pursuant to GMP requirements to help ensure that safety and quality standards are met before drugs are sold to Canadians.
The national program comprises 38 GMP inspectors, 4 supervisors, and 2 regional managers.
The program encompasses 4 key activities:
Domestic on-site inspections
Foreign on-site inspections
Foreign site evidence reviews (paper based)
Quality Management System
Drug Establishment Inspections – FY 2016/17
Rate of Compliance
Domestic Inspections
367
97%
Foreign Inspections 28
85%
Paper-Based Reviews
1,347

4. Context
Complexity of the global drug supply chain is increasing with drug products flowing across international borders…
About 80% of the drug products Canadians rely on are now imported into Canada
Increasing number of drug products produced from foreign sites in emerging markets with different regulatory systems of oversight than Canada
Multinational companies make decisions that are global in scope, often using outsourced contract manufacturing and packaging/labelling
…and the program needs to evolve to help ensure that drug products available to Canadians are safe and of high quality.

5. Year 2 of 5 of Transformation Mandate
To Enhance the Drug GMP Inspection Program to be adaptable to current and
future realities by increasing its agility and being more present globally while balancing
domestic and foreign establishments’ oversight using a more sophisticated risk-based approach
Domestic
Global
Year 2 of 5 of Transformation Mandate
Agile
Fixed
Cyclical
Risk-based
Regional
National

7. Employee Engagement Outcomes:
Opportunities for employees to participate in program transformation
Forums to identify areas of concern, challenges and offer solutions
Employee engagement sessions held nationally
Continuous engagement through committee membership and briefings
Outcomes:
4 key initiatives identified to strengthen inspection processes
Safety and Security
Mobile Technology
Virtual Tools
Training

8. Safety & Security
Initiatives of the Safety and Security working group:
Safety and Security Training Framework
List of available courses and tools for inspectors
Recorded Webex training sessions are continually accessible
Security Briefing Repository (foreign site inspections)
Developed in consultation with Global Affairs Canada and HC Security Management Division
Integration with operational processes
Revised Standard Operating Procedures and Work Instructions
Administrative procedures to support Inspectors (Contact cards, Consulate Registrations, Green Passports, Visa, etc)
Partnerships
- Ongoing collaboration with other federal organizations
Employee Engagement
Ongoing discussions and briefings with employees

9. Inspection Transformation Implementation Timeline
Virtual Tools
Promotion of virtual tools available to Program staff
development of information pages related to virtual tools
Access and use of appropriate virtual tools is essential:
Strengthen accountability and relationships
Enhance engagement, collaboration and cohesion
Promote regular communication between staff
Facilitate and improve consistency in processes
Gain efficiency and improve program delivery
Examples of Virtual Tool Options
Webcam
Laptop
Headset
Webex
Tablet
GC Connex
Video Conference
Teleconference line

10. Continuous Improvement
Mobile Technology
Creating efficiencies for inspection staff
Analysis of inspector needs while on inspection- domestic and foreign site
Engagement
Consultation with IT
Current pilot project for Surface Pro Tablet
Acquiring Technology
Performance analysis
Field testing
Improvements & efficiencies
Assessment
IMSD collaboration
Mobile technology working group
Build Relationships
Lessons learned through pilot projects to inform appropriate tool selection
Continuous Improvement

11. Training Improved formal training framework
Development of a sustainability strategy
Senior management support
Invest in learning
Communication
Performance expectation
Develop a learning policy
Maintenance: Refresher training
Continual Improvement: Training Framework
Sustainability: Training Database
Leverage in-house knowledge
Self Directed Modules
Mentoring: Leverage SMEs
Build Relationships
Day-to-day work
Networking
Cross-sector learning
Continued collaboration with partners
Learning through experience
Formal on-the-job training
Moving to experiential learning

12. Next Steps:
Year 2 of 5 of the transformation project builds on the initial engagement and initiation of activities conducted in year one
We are building capacity to progress from conception and planning of projects to implementation