Lafferty were engaged by one of our clients to provide program leadership and governance support to the site leadership team involved in the start-up of a new drug product facility located in Ireland. The program involved the start-up of a newly acquired facility consisting of a single use / ready to use multi-format filling line and associated areas.
The scope of services entailed program management and
governance of multiple workstreams critical to the site start-up and overall delivery of the business case to the client organisation.
Lafferty was engaged by the Site Leadership Team during the start-up phase of the drug product site. The start-up phase of the facility was broken down into multiple workstreams. These
■ SLT Governance and above site steering.
■ Team (HR & Recruitment)
■ Regulatory inspection readiness & approval (HPRA)
■ Technology Transfer Programs including QC/ Analytical Method Transfer Readiness. Ten TT’s across multiple formats with the initial focus on the first three PPQ batches (Commercial), and the first Clinical batch.
■ Operational Readiness & Production Scheduling
■ Finance including Capex support
■ Lafferty assumed the role of program manager providing leadership and support to each SLT member with ownership of the individual workstreams.
■ An initial assessment of the current status of each workstream was carried out, including governance/ reporting and above site steering.
■ Scope identified, defined, measured, and reported progress against each workstream.
• Site level and above site level steering support and reporting
• EHS, metrics & site maturity improvement plans.
• HPRA Inspection readiness
• Recruitment vs. budget/forecast
• Production planning during start-up activities and operational readiness support.
• Capex support and the introduction of new more robust site project management guideline and templates.
■ Risk management – focuesed workshops to identify and quantify risks across the workstreams in particular across the multiple tech transfer programs. Identification of appropriate mitigation, due dates, and owners for each risk identified. Bi-weekly reporting at steering level.
■ Weekly SLT governance provided clarity on progress from the previous week, risks identified and appropriate mitigating actions, look-ahead, and hot topics to be addressed across each of the workstreams.
■ Bi-weekly above site steering meetings to escalate hot topics / issues and drive decision making required to support delivery of each program / workstream.
The following outcomes were realised for the client:
■ Clear communications with the SLT aligned on site goals and objectives. Above site alignment with sponsors and key stakeholders.
■ Full site team aligned with clear and regular communications of site goals, objectives, and progress against the same.
■ Clear governance and steering of the site start- up phase – including the various inputs required to drive effective and timely decision making and prioritisation of site activity.
■ Visual reproting of workstream status, hot topics, issues, risks, and decisions required.
■ Risks managed with mitigation assigned to owners and due dates tracked to closure.
■ Functional managers and project managers supported in the delivery of their own objectives, and visibility / accountability driven with respect to the delivery of tech transfer programs to schedule.
■ Successful HPRA site inspection and full site MIA & IMP approal per site annual goals.
■ First commercial products 3 x PPQ batches successfully completed per site annual goals.
■ First clinical product successfully released from site per site annual goals.
■ New capital project management process implemented for site projects.
■ Improved daily mangagement board and process.