Whether the result of compliance activities by health authorities (e.g., Consent Decree, Warning Letter or 483 Inspections) or corporate initiatives, services range from audits/assessments to quality management system remediation or re-engineering. Coupled with shop floor observations, training, and coaching helps to ensure that new procedures are followed.

Experience includes creation of high level quality standards which form the basis for SOPs in GMP, GCP, and GPP areas, preapproval inspection preparation, mock audits, coaching and mentoring.

One of the most frequent categories of compliance failures due to inadequate investigations, excessive human errors, lack of or ineffective CAPAs, inexperienced investigators, backlog of open investigations > 30 days. Includes deviation investigations, OOS, OOT (both out of trend and out of tolerance) investigations.

Experience includes providing supplemental staffing, assessing and remediating inadequate procedures, acting as a 3rd party review/approver, mentoring and coaching of investigators, establishing trending and reporting, training, and planning to reduce overdue investigations backlog.

Audit and review of production and QC-generated data to identify potential data integrity issues. Potential sources include lab instrument software and security, intentional sample mislabeling, retesting of samples into compliance, inadequate OOS investigations, data recording methods.

Experience includes assessment of automated data capture, computer system security, review of procedures and actual practices.

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

Experience includes assessment of the APR program and its linkage with other quality system elements, assessment of APR content, and 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. Shop floor or lab bench observation or “polling surveys” prior to training are recommended to diagnose and to identify issues. Observation following training is recommended to ensure that training has been effective.

Experience includes assessments of training organization structure and function, training effectiveness, development of training materials, delivery, coaching, mentoring, train-the-trainer training, development and execution of “live” polling surveys.

Adequate preparation for Health Authority inspections can have a significant impact on inspection outcome. Preparation can include conduct of mock inspections (including preapproval inspections or PAI), targeted or general audits, preparation of talking points for known issues, and coaching on how to interact with health authorities. Response and commitments to health authorities in response to audit findings must be timely, well thought out, and completed per commitments to avoid severity of enforcement action.

Experience includes conduct of mock audits, presentation preparation, practice presentations, “war room” coaching, response preparation