Focus On Solutions

Insight, advice and recommendations to meet challenges on the following areas

Quality Assurance

  • The enhancement and restructuring of quality assurance operations
  • Review and enhancement of organizational structures
  • Implementation of risk analysis assessment and risk management systems
  • The optimization of manufacturing systems and processes and quality control/quality assurance systems
  • Bridging the gap between the legislative and operational GMP frameworks

Regulatory

  • The interpretation of regulations in agreement with industry standards
  • The evaluation and resolution of complex regulatory compliance issues for GMP operational areas
  • Implementation of quality in the developmental stages

Compliance

  • The identification, prevention and resolution of gaps in GMP operational areas
  • The preparation for regulatory inspections
  • The preparation for third-party audits
  • The development of corrective and preventive action plans

Training

  • The implementation of training programs from introductory to advanced levels
  • The evaluation of training programs to determine effectiveness and enhance productivity
  • Identification, assessment and resolution of gaps in GMP training systems