Serialization and track-and-trace concerns began with the Prescription Drug Marketing Act of 1987 and has evolved with the latest guidance Drug Supply Chain Security Act DSCSA). In addition to compliance requirements by numerous regulatory agencies, the pharmaceutical companies can benefit in reducing counterfeiting significantly by implementing product serialization. Serialization requires a comprehensive system to track and trace the movement of the product through the entire supply chain and engagement of all stakeholder in developing an execution plan is extremely valuable. This could potentially allow the product’s lifecycle to be traced from production, through distribution, and finally to the patient or essentially, having full visibility and control of company’s supply chain.
Although, there is currently no requirement for serialization in Canada but it is expected that the Canadian government will follow the US model for future legislation.
The webinar will cover the following topics:
- History and Background
- Requirements and Strategy Development (Including Partners, CMOs, Distributors)
- Supply Chain Assessment
- Vendor Assessment and Selection (e.g. Technology, Cost, Support and Maintenance)
- Project Execution Plan (Development and Implementation)
- System (software and hardware) Architecture and Integration
- Pilot Testing
- System Validation
- System Launch and Monitoring
Who Should Attend?
This webinar is applicable to all personnel working within a GMP supply chain environment involved in packaging and distribution of the products such as engineers (manufacturing & IT), manufacturing, supply chain, quality, and validation.
Jahan Jowharchi is the VP of Facilities and Capital Projects for PharmTech Associates, a multi-discipline consulting firm focusing on Life Science Industry. Jahan has over 25 years of experience in the pharmaceutical industry in various roles within Technical Operations including, Engineering & Project Management, Operations Management, and Quality for a range of products from Biologics, to small molecule and combination products. In various roles, he has been responsible for the development and manufacturing of products to support clinical studies, commercial launches, quality and compliance remediation. Mr. Jowharchi has been involved in planning and execution of the serialization projects in different roles ranging from an engineering manager to quality lead since the development of the e-pedigree act in 2007 which was eventually harmonized in the Drug Quality Security Act (DQSA).
Jahan has a B.S.M.E and an MBA and is an ASQ Certified Quality Auditor (CQA).
|Student Ticket:||$100.00||— Sold Out|
|Basic Member Regular:||$210.00||— Sold Out|
|Pro Ticket Regular:||$180.00||— Sold Out|