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Life Sciences
SERVICES
Regulatory Compliance
Engagement Management
Remediation Support
FDA Inspection Preparedness
SKILLS
Quality Assurance
Microbiology
Inspection Readiness
Operational Excellence
Training
Technical Writing
SITUATION
Oxford’s client, a multinational pharmaceutical and healthcare company, required a partner to support them through a remediation effort. The focus of the remediation stemmed from a backlog of deviations that needed to be investigated. Given the complexity and volume of the work, the client required a partner with deep technical expertise and experience driving robust compliance efforts to help companies through remediation efforts.
SOLUTION
Oxford was selected as our client’s partner to take full ownership of the remediation initiative. We provided a team of 40 specialized consultants, working on-site, to support 7 workstreams; Deviation Investigation, Supplier Management, Learning & Development, Microbiology, Inspection Readiness, Operational Excellence, and Technical Writing. The Oxford team, who was supported by an Oxford Project Manager, utilized best-in-class root cause analysis tools and processes to conduct thorough investigations of more than 1,000 deviations in backlog and actively addressed the findings to prevent recurrence. To address these deviations the Oxford team conducted supplier reviews and issued notices, developed and trained employees on new SOPs, work instructions and quality & compliance training modules, conducted GEMBA walk-throughs and internal audits to prepare for FDA re-inspection, and provide coaching and guidance to client employees to abate future observations.
RESULT
The Oxford Deviation Investigation team addressed the deviation backlog by identifying and documenting root causes, CAPA’s, and non-conformances. Our Supplier Management team conducted supplier reviews, issuing supplier non-conformances, and issuing supplier CAPA requests. The Learning & Development team developed and conducted training specific to newly written SOPs and work instructions as well as overall quality & compliance process enhancements. The Oxford Microbiologists supported production and facilities to instill preventive measures based on the deviation findings. Finally, our Inspection Readiness team conducted GEMBA walk-throughs along with internal audits to prepare the clients’ employees and site for FDA re-inspection. The expertise, coaching, and guidance Oxford provided for our client is invaluable to their successful re-inspection and future compliance standing with the FDA.
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