Corrective and Preventive Actions(CAPA) - 8 Steps to Achieve Compliance 2013

Key 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