Kula Jha
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Bethany Baer , Y Nguyen , Thomas Ryan Withers , Oluchi Elekwachi , Kavita Natrajan , Peter Lenahan , Laura Fontan , Andrew Harmon , Feorillo Galivo , Natasha Thorne , Simleen Kaur , Mikhail Ovanesov , Yuqun Abigail Luo , Varsha Garnepudi , Andrey Sarafanov , Emmanuel Adu-Gyamfi , Ben Cyge , Leyish Minie , Arifa Khan , Marie Anderson , Bradley Dworak , Xiaofei Wang
Detailed Analysis
Kula Jha''s approach involves meticulously reviewing documentation related to document management and process validation. They prioritize accuracy, specificity, and thoroughness in the procedures and validation documentation they inspect.
Kula Jha is a detail-oriented FDA investigator who places a strong emphasis on document management and process validation. They are particularly concerned with the accuracy and specificity of procedures, especially related to the use and handling of product contacting materials, WFI, and facility cleaning. Additionally, they prioritize thorough and detailed documentation of process validation, especially in terms of specific time storage of products within the manufacturing facility and storage conditions.
- Process Validation
- Document Management
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