Serialisation of packaged products is a regulatory requirement to protect the supply chain against counterfeit, sub-standard, mis-branded or expired drugs. There is a requirement for serialisation of US products by no later than November 2018 and EU products by Feb 2019. Current challenges are implementing fully functional and compliant solutions on time for a broad portfolio of brand owners. The challenge is significant in that the project is complex and highly technical, the costs to the business are high and the timelines are tight for very demanding customers.
The webinar will describe all the components of our serialisation journey however there will be key focus on the process of procuring equipment, validation requirements, establishing the process for transfer of serialisation data, impact on artwork and components and not least the unexpected additional requirements and costs that need to be considered. It will enhance the audience’s awareness of what to expect and how to deal with it.
In summary the webinar is intended to educate the audience and to introduce a sense of immediacy as the need to comply is very much upon us and we all need to act efficiently to avoid potential impact to our business continuity.
Dave Borthwick,
Operational Excellence Manager
I have 32 years experience working at the Morpeth (Piramal) plant and that has primarily been in production management roles. For the last 5 years I have worked as the operational excellence manager for the site, implementing a robust operational excellence programme.
Since July 2017 I have taken on the role of project manager for serialisation.
- Fully understand the costs of serialisation
- Fully appreciate the complexity and extent of the tasks required to implement serialisation solutions
- Fully understand the timelines involved and the need for detailed planning
- Fully understand the commercial aspects relating to transfer of serialisation data
- Heads of Packaging
- Packaging Engineers
- Project Managers
- Validation Managers
- IT Managers
- QA/QPs
- Site Leads
- Supply Chain Managers
