A centralized function to manage and track numerous workstreams, allocate resources, control budgets, and report progress for client initiatives.

Experience includes engineering and construction (including EPCM), remediation, QSM development and implementation, ISO certification, supplier management projects

This area is one of the most frequent categories of compliance failures, most likely due to inadequate investigations, excessive human errors, lack of or ineffective CAPAs, inexperienced investigators, backlog of open investigations > 30 days.

Experience includes providing supplemental staffing, assessing and remediating inadequate procedures, mentoring and coaching of investigators, establishing trending and reporting, training, and planning to reduce overdue investigations backlog.

Whether the result of compliance activities by health authorities (e.g., Consent Decree, Warning Letter or 483 Inspections) or corporate initiatives, activities include identification and prioritization of work streams, project planning, allocation of resources, tracking and reporting progress.

Experience includes compliance remediation activities resulting from audits by US FDA, EMA, Health Canada, internal audit findings, M&A activities.

One of the new trends in FDA 483 observations is the lack of an effective APR program, including overdue and inadequate APR reports.

Experience includes assessment of the APR program and its linkage with other quality system elements, preparing APR reports, development of a sustainable APR program.

Often the result of reductions in staffing, training organizations frequently lack the staffing and oversight required to ensure training effectiveness. Areas of focus include adequacy of staffing, training effectiveness, training materials (including course content, curricula), training methods, recordkeeping and reporting, and trending of deviations.

Experience includes assessments of training organization structure and function, training effectiveness, development of training materials, delivery.