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Dan Windfelder is listed as Regulatory Professional based in Huntingdon Valley, Pennsylvania, United States. AeroLeads shows a work email signal at prahs.com and a matched LinkedIn profile for Dan Windfelder.
Dan Windfelder previously worked as Senior Regulatory Associate at Research Pharmaceutical Services and General Contractor Project Associate at Numoda Corporation. Dan Windfelder holds Ms, Quality Assurance/Reg. Affairs from Temple University.
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I am a regulatory professional with over ten years of experience in the clinical drug industry. I have recently received a Master's Degree in Quality Assurance/Regulatory Affairs.Specialties: Knowledge of Current FDA/ICH Regulatory Guidelines, Informed Consent Review, IRB Submissions
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Fort Washington, PA
Review essential regulatory documents and informed consent forms for completeness and accuracy.Interact with RPS Clinical Operations staff, investigative site personnel, and clients in order to obtain proper clinical site documentationSupport preparations and follow-up activities related to internal and client QA audits.Know current status of all projects.
Greater Philadelphia Area
Collect and review regulatory documents required for drug shipment.Review informed consents and assist study sites with IRB submissions.Maintain Trial Master Files on behalf of the sponsor.Review and update company web-based portal which tracks study start up activity and subject enrollment.Communicate with study sponsor and vendors regarding project.
Perform activities related to clinical study initiation which include Investigator Recruitment, Investigator Document Collection, Investigator Agreements, and Investigator Meeting Coordination.Review documents for clinical drug shipment including the following: Form FDA 1572’s and related critical documents, IRB Submission and Approval Documents, Draft and.
Perform activities related to clinical study initiation.Maintain contents of on site Trial Master Files.Interact with management to assure guideline and timeline adherence.Maintain familiarity with relevant FDA/ICH guidelines.
Assisted with the analysis of adverse events of transplant patients.Evaluated and archived study safety data using the client’s database.Performed general administrative tasks.
Courses Completed: Drug Development, IND/NDA Submissions, Good Clinical Practices, Good Manufacturing Practices, Quality Audit, Industrial.
Degree includes a minor in Computer Science. Dean’s List – Fall 1994, Fall 1996
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Dan Windfelder is listed as Regulatory Professional.
AeroLeads has found 1 work email signal at @prahs.com for Dan Windfelder.
Dan Windfelder is based in Huntingdon Valley, Pennsylvania, United States.
Dan Windfelder has worked for Research Pharmaceutical Services, Numoda Corporation, Omnicare Clinical Research, and Ibah, Inc..
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Dan Windfelder holds Ms, Quality Assurance/Reg. Affairs from Temple University.
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