Expert Details

Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality

ID: 729549 California, USA

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Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included laboratory management, Inspections management, QA/QC management, CMC submissions, Supplier Quality Assurance, Auditing, Methods development and validation, Cleaning and Process Validations, vendor selection and management, root cause analysis and CAPA. As Head of QA/QC for a Fortune 500 Healthcare company, he was responsible for all aspects of QC and QA for multi-site facilities producing tablets, capsules, liquids, sterile, cosmetics, medical devices. He successfully managed several FDA/ EU NDA product approval inspections. He also established Quality unit, including GXP systems, for a specialty pharmaceutical company. He establishes Quality Systems for FDA regulated firms that wish to introduce their products, manufactured overseas, into the US marketplace.

He has designed quality system for a US virtual pharmaceutical manufacturer to enable the firm introduce its products, manufactured in Asia, into the US marketplace. He has implemented SOPs, Quality and Supply Agreements and GMP Training programs for clients.He has conducted several audits of API and finished products manufacturers for clients. He has also helped clients select vendors. He has conducted audits in the United States, India, China, and Europe.He was a member of a client's Due Diligence team that evaluated acquisition targets. Provided QA/QC input to the team, including risk assessment.He has conducted a gap analysis of a client's Quality System, put together a Remediation Plan and guided the implementation of the plan.He is currently leading a team of experts that is conducting a feasibility study of building a Sterile Manufacturing plant in Nigeria.

Education

Year Degree Subject Institution
Year: 1988 Degree: PhD Subject: Industrial Pharmacy Institution: St. John's University, New York
Year: 1984 Degree: MS Subject: Industrial Pharmacy Institution: St. John's University, New York
Year: 1979 Degree: BS Subject: Chemistry Institution: University of Ibadan, Nigeria

Work History

Years Employer Title Department
Years: 2007 to 2011 Employer: OnyexxPharma LLC Title: CEO Department:
Responsibilities:
He is an independent compliance consultant specializing in pharmaceutical, biopharmaceutical, and medical device GMP-compliance issues. He guides pharmaceutical and allied product manufacturers in the U.S. and Asia in the introduction of new products and technologies in the U.S., Africa, and other emerging economies.
Years Employer Title Department
Years: 2005 to 2007 Employer: Spectrum Pharmaceuticals Inc. Title: Vice President, Global Quality Operations Department: QA/QC
Responsibilities:
He was responsible for quality assurance / quality control initiatives in support of global drug development, clinical supplies manufacturing, commercial drug manufacturing, pre-approval inspections for new product introductions, and due-diligence efforts for in-and out-licensing activities. He implemented systems that assured laboratory and study sites in the U.S. and Europe were in full compliance.
Years Employer Title Department
Years: 2003 to 2005 Employer: Purdue Pharma LP Title: Executive Director Department: External Manufacturing & Supplier Quality
Responsibilities:
He spearheaded quality and risk-management activities pivotal for the successful launch of multimillion-dollar products sourced from third-party manufacturers and packagers. He implemented supplier auditing and qualification programs and quality and supply agreements. He provided quality directions for potential acquisition targets.
Years Employer Title Department
Years: 2001 to 2003 Employer: Purdue Pharma LP Title: Executive Director Department: Manufacturing Quality
Responsibilities:
He led quality control and quality assurance activities for all plant operations for a $2,000,000,000.00, three-plant operation. He acted as company liaison during FDA Inspections and led the development of responses to inspection observations and implementation of corrective / preventive-action plans.
Years Employer Title Department
Years: 1997 to 2001 Employer: Ortho-McNeil Pharmaceuticals (J&J) Title: Site Director, QA/QC Department: Quality
Responsibilities:
He managed a staff of over 90 responsible for manufacturing quality and compliance development and oversight for two plants representing over $2,000,000,000 in annual sales. Provided leadership in designing and implementing "Lean Lab" at the Raritan site.
Years Employer Title Department
Years: 1994 to 1997 Employer: Hoffmann-La Roche Inc., New Jersey Title: Group Leader, Analytics Department: Quality Management
Responsibilities:
He led 40 scientists engaged in analytical R&D, troubleshooting of Operations' technical issues, stability testing and management, methods development and optimization and laboratory automation.
Years Employer Title Department
Years: 1991 to 1994 Employer: Hoffmann-La Roche Title: Associate Research Investigator Department: Quality Management
Responsibilities:
Led a team of chemists that developed and validated analytical methods, developed and compiled the CMC section of NDAs.

Career Accomplishments

Associations / Societies
AAPS (American Association for Pharmaceutical Scientists); ISPE; PDA

Fields of Expertise

analytical data quality assurance, auditing, biotechnology quality assurance, continuous quality improvement, contract compliance, Current Good Manufacturing Practice, drug product approval, Food and Drug Administration, Food and Drug Administration compliance, Food and Drug Administration food packaging regulation, global regulatory procedure, inspection, laboratory quality assurance, manufacturing documentation system, manufacturing quality assurance, manufacturing quality control, medical device, medical device auditing, medical device inspection, medical device manufacturing quality control, pharmaceutical analysis, pharmaceutical drug, pharmaceutical industry, pharmaceutical liquid, pharmaceutical manufacturer, pharmaceutical manufacturing facility auditing, pharmaceutical quality assurance, pharmaceutical quality control, pre-approval inspection, product approval, product evaluation, quality, quality assurance, quality assurance management system, quality assurance project plan, quality auditing, quality control, quality documentation product, quality evaluation, quality improvement, quality management, quality standard, regulatory compliance auditing, supplier quality assurance, supplier quality improvement, vendor quality auditing, vendor selection, active pharmaceutical ingredient, internal audit, ISO 9000 auditing, ISO 9000 series quality system standard, operational auditing, ophthalmic pharmaceutical product, quality statistical method, quality-by-design, risk based inspection, drug regulation, QS-9000 quality system requirements, qualification testing, manufacturing process development, biotechnology

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