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This course reviews the regulatory requirements and methods for determining calibration specifications and relates these methods to validation of critical utilities, manufacturing processes and laboratory testing instruments. Activities in this course include analyzing different types of calibration documents and understanding how these documents are developed and used to ensure completion of validation.
The course is designed for pharmaceutical professionals with responsibilities in areas of manufacturing, validation, quality assurance, engineering and maintenance.
This 1 day, 8 hour course, covers the following topics:
- Historical perspective on calibrations
- Regulations that apply to instrument calibration programs
- Benefits of compliant instrumentation calibration programs
- Critical elements of a calibration program
- Different types and purpose of calibration documents
- Calibration Software
- Effective ways of managing a calibration business
- Audit of contracted calibration labs
- Review and approval of calibration deviations, CAPA and change control.
- Calibration performance metrics
- Benefits of going to a paperless program
Upon successful completion, participants will be able to:
- Describe important considerations for developing and maintaining instrumentation calibration programs
- Identify the four critical elements of calibration programs
- Explain the importance of instrumentation calibration programs for ensuring product quality and compliance
- Describe the components necessary for effectively managing a calibration program
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