Frederick Andersen - Asq Cqa Email & Phone Number

Andover, Ma, Us

Tokyo, Jp

April2023-October2024Execution Lead - Capital Project for Installation and Qualification of new Chromatography Skid & Supporting Utilities (Mechanical and DeltaV)~Generation of Validation Change Control Assessment & Validation Project Plan~Generation of Validation IQ, IOQ and IPQ protocols for new Chromatography Skid and modified critical utilities~Lead execution activities and provided project management with Validation status updates~Lead and provided guidance to Junior Validation ConsultantsMay2022-April2023Execution Lead - Capital Project for Installation and Qualification of new Ultrafiltration Skid & Supporting Utilities (Mechanical and DeltaV)~Generation of IQ, IOQ and IPQ protocols for new Ultrafiltration Skid and modified critical utilities~ Generation and closure of protocol discrepancies for new Ultrafiltration Skid and modified critical utilities~Lead execution activities and provided project management with Validation status updates~Lead and provided guidance to Junior Validation Consultants

Amsterdam, Nl

~Enhanced CIP Cleaning OQ Project Team Member~Suite C Autoclave Project Contributor

Salem, Nh, Us

Sr. Validation Lead Consultant ~Organized and Executed Chamber Qualification Remediation Project~Executed all monthly chamber RQs and new equipment IOPQs~Modified chamber RQ schedule from biannual to annual and created matrix to synch chamber RQ and Calibration scheduling~Revised majority of site validation protocols to streamline validation efforts, eliminate unnecessary testing and correct built-in protocol deviations~Created new equipment/ instrument onboarding procedure utilizing the USP<1058> and ASTM E2500 Standards. Procedure provided guidance for, equipment classification/criticality and validation, calibration and maintenance requirements. Procedure was required to work in tandem with a site wide Microsoft Access database system. ~Worked with Calibration Vendor to transfer all on-site balances from an annual RQ protocol execution to an annual calibration performed in accordance with USP<41> and USP<1251>~Wrote and closed CAPAs, Change Controls, and Site Deviations~Drafted and Executed IOPQ Protocols for Multiple Systems including New Clean Compressed Air System, Manufacturing Suite Door Interlocks, Existing and New Autoclave Load Patterns, Assorted Environmental Chambers

~Member and Lead of Site Wide Autoclave Remediation Project ~Validation Support for Sustainable Operations Including: -SOP and Protocol Document Generation for Multiple Systems (i.e., UF Skid SIP Modifications, Project Verification Plans, SIP PQs, Validation SOPs) -Provided Validation Support as Member of Validation Compliance Project Team -Execution of IOPQ for Clean Steam Generator, CS Distribution, Environmental Chambers, SIP PQ -Data Compilation for Site Wide Validation Master Plans

Downingtown, Pennsylvania, Us

~Provided Validation support for Sustainable Operations ~Protocol Generation/Execution~IOQ Kaye Validator 2000 Systems~Gowning Protocol Qualification~Assisted in Depyrogenation Tunnel, Vial Washer and Lyophilizer RQ Activities ~Chamber Validation (Incubators, Freezers, Refrigerators)~Shipping Validation (Cryo-Dewar, Cryo and Dry Ice Shippers, Bottle Cap Torque Degradation Study)~Equipment/Instrument Validation within new Media/Buffer Suite (FITs, Bench Top instruments, Chambers/ Mixing Vessels)~Autoclave New Load Items PQ~QC Instrument Relocations/ Vendor Revalidations (UPLC, HPLC, Blood Analyzer)~Legacy TCU Validation Remediation~IQ WFI Generation, Distribution and Storage System, Facilities/HVAC/Compressed Air/Bottle Gas System

New York, New York, Us

~Kaye Validator SME / Trainer~SIP and CIP~Cleaning Verifications for Change Over, Clean Hold Studies and Clean Monitoring Activities~Steam Quality Testing~Media/Buffer Mixing Qualification Studies~Phase Table Review for Suite Automation PLC Upgrades~Generated and Executed IQ/OQ and/or PQ Protocols on Various Environmental Chambers ~Chamber Relocation and Re-Validation Assessments~Chamber Re-Qualifications on Depyrogenation Ovens and Autoclaves~Depyrogenation Oven and Autoclave New Load Items (NLIs) PQs