Clinical Audit in Pharmaceutical Development
Clinical quality assurance audits, performed to ensure that scientific and ethical standards are met in the conduct of clinical trials, are conducted using proprietary computerized audit tools, customized to each project, so that GCP audit findings can be efficiently and consistently collected, analysed and reported. This focused systems-oriented approach to quality assurance is designed to assess and validate study conduct and documentation to ensure regulatory compliance and conformance to protocol, SOP and contractual requirements. Methodology should evaluate the activities and documentation underlying study data integrity and Good Clinical Practice (GCP) ethical and regulatory requirements.
- Clinical investigator site audits
- CRO and SMO audits
Related Conference of Clinical Audit in Pharmaceutical Development
Clinical Audit in Pharmaceutical Development Conference Speakers
Recommended Sessions
- Analytical method Quality Auditing
- Audit Planning to Ensure Maximum Effectiveness and Efficiency
- Auditing Deviations, Product Complaints, and CAPA Systems
- Clinical and Bioanalytical laboratory Audits
- Clinical Audit in Pharmaceutical Development
- GMP in Food Industry
- Goals and Strategies to Meet Audit Requirements
- Importance of Audit in Pharmaceutical Industry
- Pharmaceutical Auditing for OTC Drugs
- Quality Assurance Audits in Pharma Industries
- Quality Assurance, Quality Control and Audit
- Quality Management System in Testing Laboratories
- Regulatory Affairs