Tandem assists Clients in operational readiness of their facility for validation batches and subsequent commercial manufacturing by implementing a coordinated plan. Our method involves the following:
The Operational Readiness team made up of the stakeholders meet to review milestones and pre-requisites to achieve them:
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Technical Support/ Process Development
- Automation and IT
- Supply Chain/Logistics
- Facilities / Maintenance
An integrated micro-schedule and associated action plan are developed from the Workshop and resource loaded to ensure sufficient personnel are available to support the plan.
Effective and open communication with all stakeholders, ensuring the project goals are given focus through all phases. A weekly dashboard report is generated to communicate progress.
Weekly meetings to track progress against plan. Issuing weekly trackers to the site Ops Readiness Lead to drive daily progress meetings.
Risks, mitigations, and owners are identified and tracked.
Escalation items reviewed weekly and Key Sponsors from each stakeholder group gather to review and respond to the Operational Readiness Team.