Expert Details

QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing

ID: 728217 Maryland, USA

Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. Microbiology Release Testing-Bioburden, Sterility Test, Growth Promotion, Materials Control, Microbial Identification, Bacteria Endotoxin, Biological Indicators Testing, Potency Assays, Identity testing, Tissue Culture Assay, pH, Osmolarity, Conductivity, Sterilization (EtO & Ebeam), Biocompatibility Testing. Cleanroom Facility Design and Validation- Basis of Design, User Requirement Specification, Cleanroom Design, Facility Validation Protocol and Reports, EM Sample Site Selection, Specifications, Room Parameters, Air Exchange, HVAC, Temperature Requirements, Humidity Requirements. CAPA, OOS, Invalid Assay, Sterility Failure, Departure from QC Procedures, Environmental Excursion Investigation. Quality Control Microbiology Audit-Internal and External Auditing, Vendor Audits. FDA, USP, ISO, MCA, CFR, ICH, and EU Guidelines and Regulations. FDA, ISO, BSi, TGA, KEMA Audits- SME, Corrective Action Response for Audit Findings. QC Microbiology Lab Restructuring, Reorganization and New Lab Set up. Standard Operating Procedures (SOP), Detailed Operating Procedures (DOP), and Standard Test Methods (STM’s) Writing, Revision and compliance requirements. Test Method and Equipment Validation (MicroSeq, Vitek Compact II, VHP Sterilizer, Milliflex etc). Sterilization Experience- EtO, Terminal, Radiation Sterilization, Ebeam, VHP Decontamination. Biocompatibility Testing (USP Biological Reactivity Tests). Quality Assurance Release/Batch record review, stability test, raw materials testing, analytical testing and document control processes. Product Compliant, CAPA, Out of Specifications, Product Non-conformance Investigations/Tracking/Trending. Equipment Skills-ELISA, HPLC, VHP, Steritest, MilliflexTM, Abbott Quantum IITM Analyzer, ThinPrepTM 2000 System, Vitek Compact II, MicroSeq DNA Sequencing Equipment, Kinetic LAL Testing- ELX 808 Plate Reader, Sterilizers etc. Animal Testing/Potency Assays-Worked with Guinea Pigs, Mice, Rabbits, Injections Proficiency- Intra-cranial injections (IC), Intra-dermal injection (ID), Intra-peritoneal injection (IP) and subcutaneous (SC) Intra-venal (IV).

General Consultant for different investment firms and personal consultation within the pharmaceutical and Biotech Industries. Consultant in different areas of Quality Control, Assurance, Medical Device Sterilization, Healthcare etc for Investment firms and other clients. Expert on different topics within Sterility Assurance and Pharmaceutical manufacturing.

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Education

Year	Degree	Subject	Institution
Year: 1990	Degree: BSc	Subject: Microbiology	Institution: University of Benin-Nigeria

Work History

Years	Employer	Title	Department
Years: 2009 to Present	Employer: Undisclosed	Title: Consultant	Department:
Responsibilities: Consultant in the Pharmaceutical, Biotech, Medical Device manufacturing and testing industries. performs consultation in all areas of Quality Control/ Assurance, Sterility Assurance, Aseptic manufacturing and Testing etc.
Years	Employer	Title	Department
Years: 2006 to 2008	Employer: Abbott Vascular	Title: QC Microbiology Manager	Department: Quality
Responsibilities: High level multi-site Quality Systems/Microbiology Manager with over 45 reports overseeing a total of four (4) Quality Control Laboratories. Report to the Director of Quality Services.
Years	Employer	Title	Department
Years: 2009 to 2006	Employer: Tyco Healthcare	Title: Sterility Assurance Manager	Department: Quality
Responsibilities: I was recruited to manage and completely restructure the Quality Systems/Sterility Assurance/Control laboratory with over 35 reports in order to effect adequate change in the organization’s Quality Systems/Sterility Assurance/Control laboratory with specific emphasis on Sterility Assurance in the Aseptic and Non-Aseptic Manufacturing areas. Reported to the Director of Quality.
Years	Employer	Title	Department
Years: 2003 to 2004	Employer: Cell Genesys Inc.	Title: QC Manager	Department: Quality Control
Responsibilities: I was recruited to start up the Quality Control laboratory with more than 6 reports in order to situate the Quality Control laboratory for Phase III operation. Reported to the Director of Quality Control.
Years	Employer	Title	Department
Years: 2001 to 2003	Employer: Wyeth Pharmaceuticals	Title: QC Microbiology/Sterility Manager	Department: Quality Control
Responsibilities: I was recruited to work for Wyeth to effect total compliance in the Quality Control lab due to the Consent Decree status of the facility prior to my hire. Reported to the Director of QC/Microbiology.
Years	Employer	Title	Department
Years: 1997 to 2001	Employer: BioPort Corporation	Title: QC Bioassay Supervisor	Department: Quality Control/Bioassay
Responsibilities: QC/Bioassay Supervisor. Quality Control/Bioassay laboratory with over 20 reports with specific emphasis on QC and Bioassay (Animal Testing). Reported to the Manager of Quality Control.
Years	Employer	Title	Department
Years: 1995 to 1995	Employer: Michigan State University	Title: Research Assistant	Department: Department of Medicine
Responsibilities: Worked as a Research Assistant for the Professor of Medicine with specific emphasis on a Prothrombin time testing. Collected patient's serum samples form two major hospitals and well as from the clinical center of Michigan State University for use in the Coagulation studies. Tested the serum samples for prothrombin time (Coagulation time) using the Coagulab 40A, 60S, 32S, ACL 300, Electra 700 and Electra 1600 and reported results generated for use in the research project.
Years	Employer	Title	Department
Years: 1990 to 1995	Employer: Wuramond Hospital	Title: Assistant Microbiology Manager	Department: Microbiology
Responsibilities: Assistant Manager in the hematology and Microbiology divisions of the hospital with routine task of scheduling lab employees, assisting in managing the day to day activities of the laboratory function. Routine lab test not limited to Hematology and Clinical Microbiological Assays

International Experience

Years	Country / Region	Summary
Years: 2005 to 2005	Country / Region: Amsterdam-Holland	Summary: Conducted audits, guidance and consultation with former Dutch and Irish inspectors in areas of Quality Control, Quality Assurance and Sterility Assurance in Pharmacuetical Manufacturing process.
Years: 2007 to 2007	Country / Region: Ireland-Clonmel and Galway	Summary: Performed consultation with Quality Control/Microbiology methods.

Additional Experience

Training / Seminars
Container Closure Testing and Requirements.

Vendor Selection
Performs vendor/supplier assessments, qualification, requalification and corrective action programs.

Marketing Experience
Microbiology, Compliance, Quality Control, Quality Assurance, Sterility Assurance, Aseptic Manufacturing.

Other Relevant Experience
All areas within the Environmental Monitoring (EM) program not limited to EM Plans, Design of an EM program, EM Remediation, EM Trend Reporting, EM Excursion Investigation etc. All areas within the Gas Monitoring program not limited to Site Plans, Design of a Gas Monitoring program, Remediation, Trend Reporting, Excursion Investigation etc. All areas within the WFI Monitoring program not limited to Design of a WFI System, PM, Disinfection Plans, Remediation, Trend Reporting, Excursion Investigation etc. All Quality Control/Microbiology Testing as follows: LAL/Bacterial Endotoxin Testing, Product Validation and Suitability Tests; Bioburden Testing Program; WFI and other water testing programs (RO, Distilled, Steam, Purified); Growth Promotion Tests; GMP Testing of Raw Materials, API, and other materials and reagents used in the manufacturing and testing of products; Sterility Testing programs not limited to the design of the tests, direct and membrane filtration testing, sterility test failure investigation; Bacteriostasis and Fungistasis Testing as it relates to sterility test; Disinfectant Efficacy Testing (DE Test-In-vitro and In-vivo Tests); Biological Indicator Testing Program not limited to receipt, handling, storage, reconciliation, testing and failure investigations; Potency Assays within the Biologics manufacturing; Bioassay Testing not limited to animal testing; Virology Testing/Tissue Culture Assays; Different Media preparation, storage, expiration dating etc. pH Testing, Osmolarity, GC, HPLC, Conductivity Testing. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. Stability Testing Design, Requirements, Protocol and Report generation etc. Media Fill Program not limited to protocol/reporting design, media fill issues, failure investigation etc. Design of a Disinfection Program not limited to design, management and disinfectant and materials management. All areas of production and Process Controls. Microbial Identification systems (Vitek Compact II, MicroSeq etc) and all test procedures associated with Microbial identification Testing. All failure investigations not limited to Sterility, Environmental, Media Fill, Bacterial Endotoxin, OOS, Invalid Assays, Gas Monitoring etc. Experienced in the design, use, disinfection and validation of different types of Isolators (Soft Wall and Hard Wall), Transfer Isolators etc. Areas within validation as it relates to design, testing, Protocol/Report style and content within the areas of Method, Cleaning, Facility and Barrier Isolator validation. All Quality Systems/QA requirements and expectations as it relates to the Lab not limited to CAPA, Complaint Investigations, Document Control, Supplier Quality, Batch Record/Release, Deviation, and others. Biocompatibility Testing Requirements. EtO, Steam, VHP and Ebeam Sterilization Validation and Testing Requirements. Startups and Restructuring of a non-compliant lab into a very compliant QC Lab. Experienced in a vast array of QC Lab Procedural Revision, Writing and Design as well as all Forms associated with each procedure to meet the USP, ISO, EP, JP etc expectations. SME in all areas of Quality Systems as it relates to the Labs, Microbiology, Virology etc. SME in all areas of Pharmaceutical, Biotechnology, Radiopharmacuetical, Drugs, Biologics and Aseptic Manufacturing and Microbiological Assays.

Other Relevant Experience

All areas within the Environmental Monitoring (EM) program not limited to EM Plans, Design of an EM program, EM Remediation, EM Trend Reporting, EM Excursion Investigation etc. All areas within the Gas Monitoring program not limited to Site Plans, Design of a Gas Monitoring program, Remediation, Trend Reporting, Excursion Investigation etc. All areas within the WFI Monitoring program not limited to Design of a WFI System, PM, Disinfection Plans, Remediation, Trend Reporting, Excursion Investigation etc. All Quality Control/Microbiology Testing as follows: LAL/Bacterial Endotoxin Testing, Product Validation and Suitability Tests; Bioburden Testing Program; WFI and other water testing programs (RO, Distilled, Steam, Purified); Growth Promotion Tests; GMP Testing of Raw Materials, API, and other materials and reagents used in the manufacturing and testing of products; Sterility Testing programs not limited to the design of the tests, direct and membrane filtration testing, sterility test failure investigation; Bacteriostasis and Fungistasis Testing as it relates to sterility test; Disinfectant Efficacy Testing (DE Test-In-vitro and In-vivo Tests); Biological Indicator Testing Program not limited to receipt, handling, storage, reconciliation, testing and failure investigations; Potency Assays within the Biologics manufacturing; Bioassay Testing not limited to animal testing; Virology Testing/Tissue Culture Assays; Different Media preparation, storage, expiration dating etc. pH Testing, Osmolarity, GC, HPLC, Conductivity Testing. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. Stability Testing Design, Requirements, Protocol and Report generation etc. Media Fill Program not limited to protocol/reporting design, media fill issues, failure investigation etc. Design of a Disinfection Program not limited to design, management and disinfectant and materials management. All areas of production and Process Controls. Microbial Identification systems (Vitek Compact II, MicroSeq etc) and all test procedures associated with Microbial identification Testing. All failure investigations not limited to Sterility, Environmental, Media Fill, Bacterial Endotoxin, OOS, Invalid Assays, Gas Monitoring etc. Experienced in the design, use, disinfection and validation of different types of Isolators (Soft Wall and Hard Wall), Transfer Isolators etc. Areas within validation as it relates to design, testing, Protocol/Report style and content within the areas of Method, Cleaning, Facility and Barrier Isolator validation. All Quality Systems/QA requirements and expectations as it relates to the Lab not limited to CAPA, Complaint Investigations, Document Control, Supplier Quality, Batch Record/Release, Deviation, and others. Biocompatibility Testing Requirements. EtO, Steam, VHP and Ebeam Sterilization Validation and Testing Requirements. Startups and Restructuring of a non-compliant lab into a very compliant QC Lab. Experienced in a vast array of QC Lab Procedural Revision, Writing and Design as well as all Forms associated with each procedure to meet the USP, ISO, EP, JP etc expectations. SME in all areas of Quality Systems as it relates to the Labs, Microbiology, Virology etc. SME in all areas of Pharmaceutical, Biotechnology, Radiopharmacuetical, Drugs, Biologics and Aseptic Manufacturing and Microbiological Assays.

Fields of Expertise

applied microbiology, aseptic filling, aseptic packaging process, aseptic pharmaceutical process validation, bio-clean room, bioburden, decontamination equipment, environmental air sampling, Food and Drug Administration, FDA medical device regulation, Food and Drug Administration regulation, medical device, medical device manufacturing quality control, medical device sterility, nonaseptic pharmaceutical process validation, pharmaceutical aseptic filling room, pharmaceutical manufacturing facility auditing, pharmaceutical quality assurance, pharmaceutical quality control, quality control, sterile, sterile packaging process, sterile processing, sterile product aseptic manufacture, sterility, sterility assurance level, product compliance, biological testing, product evaluation, compliance, active pharmaceutical ingredient, pre-approval inspection, supplier quality engineering, biocompatibility testing, Bacillus subtilis, product approval, environmental air quality, medical device auditing, pharmaceutical product shelf life testing, medical device clinical research, ISO 9000 series quality system standard, biotechnology quality assurance, biofilm, environmental site auditing, auditing, European standard, quality assurance management system, sterilant, quality improvement, environmental testing, pharmaceutical water treatment system validation, testing, quality auditing

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Expert Details

QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing

Education

Work History

Responsibilities:

Responsibilities:

Responsibilities:

Responsibilities:

Responsibilities:

Responsibilities:

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International Experience

Additional Experience

Fields of Expertise