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