Rakshith Katta

Spearheading FDA Third-Party Review accreditation (3P510k) including SOP, QA system, reviewer hiring, mock submissions. Overseeing device regulatory strategy, QMS implementation, and eSTAR training pipeline.

Led a team of 7 in a 5 million dollar CIPT project at the FDA OSE

Developed training guides and curriculum for FDA Pharmacy Compounding Work Management systems.
Created process flow diagrams and documented regulatory business workflows.

Conducted requirement gathering and produced activity diagrams, use cases, and reports.
Implemented dashboards, custom templates, and advanced reports for regulatory task tracking.
Supported OBI EPICs and FDA CIPT workstreams, ensuring effective training alignment.
Assisted Program Manager in tracking metrics, quality control, and stakeholder coordination.

Trained 150+ FDA staff on Panorama, Appian, Mercado platforms.
Managed HHS DCIO training rollout; led informatics bootcamp for CDER.
Developed eTMF, eCTD, eCRF templates and led lifecycle tracking software showcased at DIA 2016.
Participated in FDA submission planning, SOP preparation, and QA readiness.