Kenneth Daus Email & Phone Number

Audited complex and detailed custom assays for accuracy and compliance with the standard operating procedures and the regulations Conducted facility and in-process inspectionsPerformed critical document reviews of standard operating procedures, batch records, protocols, technical specifications and reports Trained new quality auditors to perform various study audits, conduct facility inspections and critical document review as a qualified trainerWorked with operation groups to implement procedures to improve data accuracy and reporting turnaround times

Audited nonclinical laboratory (Mycoplasma, Molecular, Invitro and Sterility) studies to assure compliance with the current Good Manufacturing Practice (cGMP) and/or Good Laboratory Practice (GLP) regulations as well as the protocol and standard operating proceduresInspected and audited laboratory personnel while performing and documenting assays; assuring the facilities are safe and in complianceDocumented and reported observations to the study directors and company management through the execution of system based inspections and reporting via an electronic quality management systemWorked with various levels of operations and management to implement quality throughout the process and give guidance when needed

Reviewed and verified the scientific accuracy of data submitted by manufactures, distributors, labelers and repackers through various FDA drug listing and registration formsAdvisor on industry requirements of the Drug Listing Act of 1972 (Title 21 of the CFR, Part 207) for foreign and domestic firmsInteracted with government officials and agencies regarding the interpretation of policy (CFR) and Drug Registration and Listing System (DRLS) informationProvided technical training to professional and entry level reviewers in processing establishment registration and drug listing formsPlanned and processed special projects including the verification, processing and mailing of over 2300 annual compliance verification reports (CVRs)