Process Validation for pharmaceutical and Biopharmaceuticals 2013

Key Topics

• FDA Process Validation (PV) to encompass a new lifecycle approach
• A Comparison of the 1987 and 2011 FDA Process Validation Guidelines
• Developing VMP aligned with the new Guidelines
• A Lifecycle Approach to Pharmaceutical Validation
• The expectations, requirements and scientific rational behind Process Validation of Unique excipients, Alternative APIs and excipients in general
• The expectations, requirements and proposed plan as per the new FDA guideline for 3 stages Process Validation
• Principles and Components of Stage 2 Process Validation
• Principles and Components of Stage 1 Process Validation
• Statistical Tools for Determining and Monitoring Process Control and Process Capability
• Using simple Risk Analysis and Statistical Tools to improved Control and Validation of Manufacturing Processes for Transferred and Legacy Products

Who should Attend

Managers, directors, technicians and personnel from Biotechnology and Pharmaceutical industries responsible for::

• Quality Assurance involved in auditing validation protocols and reports
• Quality Control
• Regulatory agency inspectors
• RA staff
• Validation specialists from manufacturing, engineering, and maintenance departments
• Manufacturing personnel engaged in validation activities
• Facilities
• Process Design and Development
• Change Control
• GMP/GLP Compliance
• Training
• Documentation
• Consultants