Lori Silverstein Email & Phone Number

Kirkland, Wa, Us

Kirkland, Wa, Us

Seattle, Washington, Us

Sr consultant, FDA mock inspections for drug, device, and clinical inspection preparation.

Seattle, Wa, Us

Assoc director, audit vendors, Clinical investigator sites, GLP, clinical study team quality member, metrics, protocol review, clinical report review.

Silver Spring, Md, Us

Seattle District Supervisory Consumer Safety Officer -Drug TeamSupervised a team of nine drug investigators to conduct pre- and post-approval inspections, inspections of small volume parenterals, sterile drugs, compounding pharmacies, finished dosage drugs, active pharmaceutical ingredients, and biotechnology derived drugs, etc. Territory coverage for the Seattle District included Washington, Oregon, Idaho, Montana, and Alaska. Participated in the review and preparation of administrative actions in conjunction with the Compliance Branch including warning letters, untitled letters, and regulatory meetings.

Silver Spring, Md, Us

Medical Device Specialist, Consumer Safety Officer (Investigator) • January 2010-January 2016 Independently conducted complex domestic and foreign bioresearch monitoring inspections and medical device and combination product GMP inspections: Lead investigator for inspections of medical devices including interventional cardiology devices, AEDs, ultrasound, IVD, etc., auditing quality systems against cGMP. Trained new medical device investigators in the conduct of complex cGCP and cGMP inspections. Independently conducted and led teams to conduct domestic and foreign complex Bioresearch Monitoring inspections of sponsors, clinical investigators, sponsor-investigators, CROs and IRBs auditing research activities against cGCPs; advise investigators in the development of evidence during the conduct of cGMP and BIMO inspections.