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

Available for your Consulting and Expert Witness Needs

California (CA)
USA

Education

Work History

Career Accomplishments

Consulting Services

Expert Witness

Summary of Expertise:

Listed with other top experts in:

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.

•	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

Show Secondary and Basic Areas of Expertise

Localities:
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; and Chula Vista, California.

Education:

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

Work History:

Years	Employer	Department	Title	Responsibilities
2007 to 2011	OnyexxPharma LLC		CEO	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.
2005 to 2007	Spectrum Pharmaceuticals Inc.	QA/QC	Vice President, Global Quality Operations	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.
2003 to 2005	Purdue Pharma LP	External Manufacturing & Supplier Quality	Executive Director	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.
2001 to 2003	Purdue Pharma LP	Manufacturing Quality	Executive Director	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.
1997 to 2001	Ortho-McNeil Pharmaceuticals (J&J)	Quality	Site Director, QA/QC	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.
1994 to 1997	Hoffmann-La Roche Inc., New Jersey	Quality Management	Group Leader, Analytics	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.
1991 to 1994	Hoffmann-La Roche	Quality Management	Associate Research Investigator	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

Professional Appointments

Former Editor: Pharmaceutical Quality and Control and Dissolution Technlogies

Consulting Services:

Selected Consulting Examples:

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.

Recent Client Requests:

Expert business for specialty pharmacy for consulting on specialty pharmacy.

Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs. Expert is available for consulting to corporate, legal and government clients. Remember, your initial screening call to speak with Expert is free.

Expert Witness:

Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services. A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening call to speak with Expert is free.

International Experience:

Years	Country / Region	Summary
1996 to 1997	Rome	QA/QC representative on strategic partnership meetings with an Italian pharmaceutical company.
2002 to 2010	India	Several trips to India on audits of API and Excipient manufacturers. Trips to qualify and select finished products and API manufacturers.
2003 to	China	Trip to audit an API manufacturer and to investigate another for material failure.
2003 to	Spain	Part of a Due Diligence team for an acquisition target.
2007 to	Germany and the Netherlands	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.

Additional Skills and Services:

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.

Supplier and Vendor Location and 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 Skills and Services

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


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