Topics
- Review the most likely areas for scrutiny
- Understand the basis for complete documentation
- Defining adequate control measures to ensure compliance
- Establishing effective procedures that will pass inspections with ease
- Rehearsing effectively for regulatory audits
- Determining proper review techniques for records and reports
- Developining an SOP for CAPAs and investigations
- Reviewing the documents required by the FDA
Who should Attend
Personnel from companies in the Diagnostic, Medical Device, Biologics and Pharmaceutical fields, including:
- Manufacturing and operations personnel
- Regulatory affairs professionals
- Quality control personnel
- QA managers and personnel
- Logistics and supply personnel
- Facility maintenance and calibration personnel
- GMP/QSR auditors
- Any employee involved in regulatory audits
- Manufacturing directors and supervisors
- Executive management
- Risk management specialists
- R&D staff
- Training personnel
