The Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing 2016 is a seminar that covers topics such as:
- 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
The Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing 2016 brings together:
- 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
