Sample interview questions: Can you discuss your experience in validating analytical methods or techniques for regulatory compliance purposes?
Sample answer:
- Experience in Validating Analytical Methods and Techniques for Regulatory Compliance Purposes:
- Conducted comprehensive validation studies to ensure the accuracy, precision, sensitivity, and specificity of analytical methods used in the laboratory.
- Followed regulatory guidelines and industry best practices, such as ISO 17025 and Good Laboratory Practices (GLP), to ensure compliance with relevant standards.
- Developed and implemented validation protocols and procedures to evaluate the performance characteristics of analytical methods.
- Conducted thorough testing to assess method parameters, including linearity, range, limit of detection, limit of quantitation, accuracy, precision, robustness, and selectivity.
- Analyzed and interpreted validation data using statistical tools and techniques to determine the validity and reliability of analytical methods.
- Prepared detailed validation reports summarizing the findings and conclusions of the validation studies.
- Expertise in Troubleshooting and Method Optimization:
- Demonstrated proficiency in troubleshooting and resolving analytical issues related to method performance, instrumentation, and sample preparation techniques.
- Conducted thorough investigations to identify the root causes of analytical problems and implemented corrective actions to rectify issues.
- Performed method optimization studies to improve the efficiency,… Read full answer