Process Validation in the US and EU

Benefits in Attending:
Understand the link from product requirements, to equipment verification and process validation
Clarify the similarities and differences between process validation expectations in the EU and US
Establish a Process Validation programme
Understand the link between Quality by Design and Process Validation
Gain a practical, science and risk-based approach to Process Validation including Equipment Verification
Apply relevant tools for Process Validation, such as Risk Assessments, Design of Experiments and Statistics
Gain knowledge in Good Engineering Practice (GEP)
Unscramble the real meaning of ‘buzz words’ such as Qualification, Verification, Commissioning, Validation etc.
Realise significant business benefits from a science and risk-based approach

This seminar will be of particular inveterst to all those from the Pharmaceutical Industry working in:
Development
Manufacturing
Engineering
Quality
Personnel from the Pharmaceutical and Biopharmaceutical Industry with the following background:
Process Engineers
Pharmacists
Scientists
Quality Assurance Professionals
Quality Control Managers
Late Stage Product and Process Development Engineers, Scientists, Pharmacists
Technology Scale Up and Transfer Managers
Validation and Qualification Managers
Validation and Qualification Specialists
Risk Management Specialists
Lean Management Specialists
Operations Managers, Engineers