FDA Compliant GLP for Nonclinical Studies - For Pharmaceutical and Medical Device Industries is a seminar that covers topics such as:
- Good laboratory practices: scope, objectives and definitions
- US FDA GLP regulations and requirements
- Facilities and equipment
- Organization and personnel: personnel, management, study director and quality assurance unit
- Test and control articles
- Testing facilities operation: standard operating procedures (SOPs)
- Records and reports
- Protocol and conduct of a GLP study
- Preparing for GLP inspection
- Implementing GLPs
- GLP workshop for GLP implementation
- Numerous case studies for deficiencies and for improvement
FDA Compliant GLP for Nonclinical Studies - For Pharmaceutical and Medical Device Industries brings together:
- Product and development (associates, scientists, managers, directors and VPs)
- Research and development (associates, scientists, managers, directors and VPs)
- Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
- Regulatory affairs (associates, specialists, managers, and directors)
- Site managers, and consultants
- Contract research organization (associates, scientists, managers, directors and VPs)
- Contractors and subcontractors
- Senior and executive management (VPs, SVPs, Presidents and CEOs)