Recruitment/human Resources

Project resource management includes forecasting the need to hire and/or outsource some tasks. When projects are high-value and require strategic decisions, in-house resources may be insufficient. Similarly, administrative action items are better left to contract workers so as to not overburden your staff....

• Quality Systems Development • Data Integrity • Quality IT Systems • Quality Remediation • Management Controls • Risk Management • Design Controls • Project Management • Train and Qualify Staff

• Inspection Event Planning • Personnel Training and Interview Preparation • Subject Matter Expert Support • Post-Inspection Analysis

• Management Review • Validation and Qualification • Risk Management • Laboratory Controls • Batch Review • Quality Engineering • Exceptions • Post Market Surveillance

• FDA/EMA/Health Authority Agency Intelligence • Rapid Response to Inspections • Remediation Support • On-Site Remediation Project Management • Coordination with Regulatory Counsel • Third-Party Support

• Quality control Operations Assessment • Data Integrity Remediation • Quality Control Organisational Assessment • Interim Subject Matter Experts • Interim Management Staffing