Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing 2016

Key Topics

• Documents required for equipment qualification and process validation and how to manage documents appropriately
• The global expectations for equipment qualification and validation
• Write and execute sound protocols for equipment qualification (IQ, OQ, PQ) and process validation
• How to write and maintain a Validation Master Plan
• Collect data, conduct tests, and obtain all necessary documents
• Qualify already existing systems and requalification
• Performance Validation
• The different types of validation
• The principles of auditing the equipment qualification and validation
• Validating analytical methods and processes
• How to investigate true root causes of problems and to evaluate and prioritize solutions
• External qualification and validation from a contract manufacturer, and qualification and validation by a supplier
• Develop successful implementation plans
• Problem solving methods to help you asses which is best for your situation
• Perform risk assessments effectively

Who should Attend

• Quality professionals
• Senior quality managers
• Compliance professionals
• Regulatory professionals
• Validation engineers
• Production supervisors
• Production engineers
• Manufacturing engineers
• Process owners
• Design engineers
• Quality auditors
• Quality engineers
• Document control specialists