Executive Director, Regulatory Affairs, Quality Management, Safety & Health
11:35 AM How can we Successfully Transition from Clinical to Commercial Operations while Remaining Compliant of GMP’s and Regulatory Agencies?
1:50 PM Preparing your Supply for the Regulatory Provisions Outlined in Health Canada Guide-00069 from Frozen to CRT
Tony and Rafik will discuss the Health Canada Guide-00069 regulations and requirements in Canada and provide detailed examples compliance and non-compliance regarding:
- Review guidelines for products in transit: stability data requirements and temperature mapping
- Discus the regulatory scope of temperature monitoring for CRT
- Risk valuation and mitigation and analyze examples of compliance and non-compliance
- How to implement locally to distribute to Canadian customers to fulfill authority requirements
- Discuss the global regulatory landscape for CRT products and where they may get flagged more often
12:20 PM PANEL: Planning and Executing Change Management Practices- Avoiding the “Lost in Translation” Effect
Many companies like AbbVie depend on their supply chain managers to qualify the lane and mange internal collaboration between IT, Finance, Logistics, Quality and Packaging to ensure synergy and overall goals are clear. What are the best ways to manager internal collaboration and align staff to change their mentalities and align them to the companies overall strategy.
- Launch life science product enhancements and adapting to engineering changes
- Provide engineering change management for improving handoff from new product development to commercial product support in order to develop change management functions
- Engage in enterprise-wide response to change through effective management of product, responses to changing market conditions and increased rates of product innovation