Kathleen Wolfe Email & Phone Number | I have over 25 years of experience in the Pharmaceutical and Scientific field. I have worked with clients on training and troubleshooting on the Submit software. I worked with developers to test new versions of the application. Well versed in FDA Regulations for scientific data collection application validation. This includes Validation Plan, Risk Assessment, Traceability Matrix, User Requirements, Test Scripts, and Validation Report. Also versed in Application Life Cycle Development which would include Change Controls and Periodic Reviews. Proven ability to work in coordination with Clients and Project Teams to conform to FDA Regulations. Ability to meet deadlines, working independently or as a team member. Expertise includes: • Instem Submit • CSV (Validations, Change Control, Periodic Review) • Provantis • Developing SOP’s for Validation • GxP • Supporting Non-Clinical Safety GLP and non-GLP projects both Global and Local. • Creating and verifying SEND EG, CV, VS, and RE domains for submission to FDA.

Kathleen Wolfe

I have over 25 years of experience in the Pharmaceutical and Scientific field. I have worked with cl...
Fort Pierce, Florida, United States

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Kathleen Wolfe’s Email kwolfe@criver.com

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Kathleen Wolfe’s Location Fort Pierce, Florida, United States

Kathleen Wolfe’s Current Industry Charles River Laboratories

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Sr. Analyst, Electronics Submissions

2017-10-01 00:00:00 - Present

Senior Consultant

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Kathleen Wolfe is a I have over 25 years of experience in the Pharmaceutical and Scientific field. I have worked with clients on training and troubleshooting on the Submit software. I worked with developers to test new versions of the application. Well versed in FDA Regulations for scientific data collection application validation. This includes Validation Plan, Risk Assessment, Traceability Matrix, User Requirements, Test Scripts, and Validation Report. Also versed in Application Life Cycle Development which would include Change Controls and Periodic Reviews. Proven ability to work in coordination with Clients and Project Teams to conform to FDA Regulations. Ability to meet deadlines, working independently or as a team member. Expertise includes: • Instem Submit • CSV (Validations, Change Control, Periodic Review) • Provantis • Developing SOP’s for Validation • GxP • Supporting Non-Clinical Safety GLP and non-GLP projects both Global and Local. • Creating and verifying SEND EG, CV, VS, and RE domains for submission to FDA.