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

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

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

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.

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

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

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

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

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

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

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