Expert Details

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

Expert 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.

Expert may consult nationally and internationally, and is also local to the following cities: Los Angeles, California - San Diego, California - Long Beach, California - Santa Ana, California - Anaheim, California - Riverside, California - Glendale, California - Huntington Beach, California - San Bernardino, California - Chula Vista, California

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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 Responsibilities
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: 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: 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: 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: 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: 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: 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.

International Experience

Years Country / Region Summary
Years: 1996 to 1997 Country / Region: Rome Summary: QA/QC representative on strategic partnership meetings with an Italian pharmaceutical company.
Years: 2002 to 2010 Country / Region: India Summary: Several trips to India on audits of API and Excipient manufacturers. Trips to qualify and select finished products and API manufacturers.
Years: 2003 to Present Country / Region: China Summary: Trip to audit an API manufacturer and to investigate another for material failure.
Years: 2003 to Present Country / Region: Spain Summary: Part of a Due Diligence team for an acquisition target.
Years: 2007 to Present Country / Region: Germany and the Netherlands Summary: Audit of Laboratories for GLP studies. Visit with study partner for follow up audit and close out of previous audit findings and review of CAPA.

Career Accomplishments

Associations / Societies
AAPS (American Association for Pharmaceutical Scientists); ISPE; PDA
Professional Appointments
Former Editor: Pharmaceutical Quality and Control and Dissolution Technlogies

Additional Experience

Training / Seminars
Provided company-wide training on Good Manufacturing Practices, Good Laboratory Practices, General Regulatory Agency Inspection Readiness. Have provided targeted training on Supplier Qualification and Selection, Development of SOPs and Product Complaint Handling.
Vendor Selection
As Executive Director Supplier Quality, he led the qualification and selection of contract manufacturers and contract testing laboratories for company. Led the development of strategies for selecting contract testing laboratories at Hoffmann-La Roche.

He has helped source, qualify and select API and finished products contract manufacturers for clients. Vendors evaluated were located both within the United States, Europe and Asia.

Other Relevant Experience
He has traveled to developed and emerging economies, including the USA, India, Japan, China, Nigeria, Brazil, Spain and Germany for projects.

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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