I have extensive experience in validation processes within highly regulated industries such as pharmaceuticals and medical devices. I have successfully led validation projects, ensuring compliance with FDA and ISO standards. My expertise includes developing validation protocols, executing validation activities, and preparing comprehensive validation reports. I am well-versed in risk assessment methodologies like FMEA and have a strong understanding of GxP principles, which I apply to ensure robust and compliant validation practices.

When encountering deviations or non-conformances, I follow a systematic approach. First, I thoroughly investigate the root cause using tools like root cause analysis (RCA). Next, I collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPA). I ensure that all actions are documented and that the validation process is re-evaluated to confirm compliance. This approach ensures that any issues are promptly addressed, and the validation process remains robust and compliant.

In my previous roles, I have utilized various tools and software to support validation activities. These include TrackWise for document control and deviation management, LabWare LIMS for laboratory data management, and Microsoft Project for project scheduling. I am also proficient in statistical analysis tools like Minitab and have experience with automation systems for equipment validation. My familiarity with these tools allows me to efficiently manage validation projects and ensure data integrity.

I ensure the accuracy and completeness of validation documentation through a meticulous review process. I carefully cross-reference all documents against the validation plan and regulatory requirements. I also conduct peer reviews and involve subject matter experts to verify technical accuracy. Additionally, I maintain a detailed audit trail and ensure that all changes are properly documented and approved. This rigorous approach ensures that all validation documentation is reliable, traceable, and compliant with regulatory standards.

My approach to validating computerized systems involves several key steps. First, I conduct a risk assessment to identify critical functionalities. Next, I develop and execute validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). I ensure that all testing is comprehensive and that any deviations are addressed. Finally, I prepare a detailed validation summary report, documenting the entire process and confirming that the system meets all predefined criteria. This structured approach ensures that computerized systems are validated in a compliant and efficient manner.