Expert Profile
Charity Ogunsanya
Director of Quality Control, Pharmabiodevice Consulting LLC
Charity Ogunsanya has over 30 years of extensive experience within the Pharmaceutical, Biotechnology, Biologics, Cell-Therapy, Diagnostics, Research and Development, Radio-pharmaceutical, Contract Manufacturing Organization (CMO) and Medical Device companies.
Throughout her corporate career within these diverse industries, she held various high visibility and business critical roles within the Quality and Compliance division in major Fortune 100 companies both as a Subject Matter Expert (SME), Site Manager, Multi-site Manager and Director Levels receptively. She has been a sought after expert and have been consistently hired after several competitive efforts by major fortune 100 companies to assume key roles specifically related to remediation and difficult Quality and Compliance related deficiencies associated with FDA’s Consent Decree, FDA’s Warning Letters and difficult regulatory bodies inspectional findings which is always achieved with a successful outcome. She has also been a sought after expert by various companies requesting her expertise as a known industry expert to specifically assume roles in order to perform a total overhaul, restructure, compliance remediation, re-organization, start-up processes related to Quality Systems improvements and/or enhancements. In all cases, her remediation work resulted in several successful National and International regulatory bodies’ inspections, re-inspection and new product approvals.
Her technical expertise are not limited to the interpretation, administration and set up of Quality Assurance, Quality/Compliance, Quality Engineering, Aseptic Processing, Contamination Control, Quality Control, Microbiology, Sterility Assurance, Stability, Vaccine Development, New Product Design, Product Release Testing and Medical Device Sterilization (Ethylene Oxide (EtO), Gamma, Radiation, VHP sterilization) systems and operations for compliance to various regulations.
Ms. Ogunsanya is vast in the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization and post-approval inspections. Her expertise has been sought after by several Fortune 100 Pharmaceutical, Biotechnology, Biologics and Medical Device companies as a Quality and Compliance SME during critical national and international regulatory bodies’ routine and new product approval inspections.
She is the CEO of Pharmabiodevice Consulting LLC (www.pharmabiodeviceconsultant.com) targeted towards Quality and Compliance related remediation, enhancements and consultant services for various companies within the industry. She is a well sought after high level consultant for several international professional expert networks such as Gerson Lehrman Group, Zintro Expert Network and Intota Expert Network. She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network.
Trainings by Expert
Product Stability Testing Program - Designing and Sustaining New and Existing Programs
Category:
Drugs and Chemicals (Pharma)
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Medical Devices
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Biotechnology
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Laboratory Compliance
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All FDA Regulated Industry
,
Testing and Validation
,
Quality and Safety
,
QMS, ISO 13485, CAPA
,
Laboratory
,
Quality & Safety
,
Technologies and Processes
,
Drugs Regulations
,
Biotech Regulations
,
Life sciences QA/QC
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
Category:
Drugs and Chemicals (Pharma)
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Medical Devices
,
Biotechnology
,
Laboratory Compliance
,
All FDA Regulated Industry
,
Quality and Safety
,
Sterilization
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Laboratory
,
Contamination Control
,
Quality & Safety
,
Drugs Regulations
,
Biotech Regulations
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Biotechnology
,
Laboratory Compliance
,
All FDA Regulated Industry
,
Quality and Safety
,
Sterilization
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Laboratory
,
Contamination Control
,
Quality & Safety
,
Drugs Regulations
,
Biotech Regulations
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Biotechnology
,
All FDA Regulated Industry
,
Testing and Validation
,
Documentation and IT
,
Quality and Safety
,
Sterilization
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Laboratory
,
Contamination Control
,
Quality & Safety
,
Technologies and Processes
,
Life sciences QA/QC
,
Life Sciences
,
QA/QC
Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)
Category:
Drugs and Chemicals (Pharma)
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Medical Devices
,
Biotechnology
,
Laboratory Compliance
,
All FDA Regulated Industry
,
FDA Validation
,
Testing and Validation
,
Documentation and IT
,
Quality and Safety
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Laboratory
,
Contamination Control
,
GLP & Other Best practices
,
Microbiology Laboratory
,
Clinical Laboratory
,
Analytical Laboratory
,
Quality & Safety
,
Technologies and Processes
,
Drugs Regulations
,
Biotech Regulations
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Food Safety & Quality
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
Common FDA Regulations
,
QA/QC
Performing an Effective Out-of-Specification Result Investigation
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Biotechnology
,
All FDA Regulated Industry
,
GXP Pharmaceutical
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GXP Medical Devices
,
FDA Validation
,
Testing and Validation
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Laboratory
,
Microbiology Laboratory
,
Quality & Safety
,
Drugs Regulations
,
Biotech Regulations
,
Life sciences QA/QC
,
Regulations & Guidances
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
CGMP controlled Raw Materials
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Risk Management
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All FDA Regulated Industry
,
Testing and Validation
,
Quality and Safety
,
Audits & Inspections
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Cosmetics
,
Food & Dietary Supplements
,
Manufacturing & Contamination control
,
Drugs Regulations
,
Food Safety & Quality
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
Pharmaceutical Water System: Design, Testing and Data Management
Category:
Drugs and Chemicals (Pharma)
Basic Cleanroom Technology, Operation and Contamination Control in a Nutshell
Category:
Drugs and Chemicals (Pharma)
The Relationship of Designing an Effective Environmental Monitoring Program and Determining a Cleanroom State of Control
Category:
All FDA Regulated Industry
