Our
Projects
This is an example of what we have helped our clients/affiliates achieve so you could understand the context, background, depth/breath of our services and end product deliverables.
Project Name
USFDA Pre-PAI Audit of Aseptic/Sterile Sites, GXP, GVP, 2 Dossiers’ & QS’ Remediation
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Co-led Pre-PAI Audit with another consultant, comprising investigation and recommended solution alternatives for remediation of found QS/site/dossier deficiencies.
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Appointed Project Manager by client for the pre-PAI Audit remediation project: deliverables for 5 senior consultants and 12 of client’s personnel.
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Client received US market approval of a generic drug and a combination drug-medical device upon completion of each PAI.
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Trained client’s personnel and then led the evaluation of client’s two new drug dossiers for proper safety/effectiveness per own QbD NPD Method/Toolset - see above “2017-Present” project statement. Discovered, investigated and properly remediated found deficiences.
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Authored new SOPs and Execution Forms for Nonconformance, CAPA and Change Control. Directed the proper development of SOPs for Risk Management, Data Integrity, Chromatographic Manual Integration, Quality Metrics, CSV - 21CFR Part 11, Annex 11 and GAMP V (DCS, PLCs and SCADA), Statistics, SOP-on-SOP, Personnel Training, Re-Qualification of Analytical and Microbiology Laboratory Personnel.
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Eliminated 30% of SOP redundancy in client’s QS and began to implement plan for transforming client’s QS into only one level risk-based, disposition decision system.
Project Name
FDA Audit/ Remediation & QS Improvement of API’s R&D Facility, GxP, GVP Sites
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Completed QS audit of an API R&D facility comprising investigation and recommendation alternatives for remediation of found deficiencies.
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Led the fundamental revision and/or creation/development of client’s Change Control, Nonconformance/CAPA (TrackWise), Data/Record Documentation and Control, Calibration, Maintenance and Validation sub-system SOPs.
Project Name
FDA Audit/ Remediation & Quality System Improvement of API’s Manufacturing Aseptic/Sterile GXP Facility
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Completed QS audit of a large API manufacturing facility comprising investigation and recommendation alternatives for remediation of found deficiencies.
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Identified LSS Quality System and manufacturing opportunities for significant reduction of complexity, contamination/mixup potential and related risk: estimated 18% reduction in the number of SOPs, nearly 100% control and audit of sample custody, significant improvements in data integrity and risk based disposition decisions.
