ComplianceOnline

Expert Profile


Charity Ogunsanya
Director of Quality Control, Pharmabiodevice Consulting LLC

Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies.

She has been a much sought after SME 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 other regulatory bodies’ inspectional findings. Her remediation work has constantly resulted in several successful national and international regulatory bodies’ inspections, re-inspections and new product approvals.

Her technical expertise covers and goes beyond 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.

She has a keen working knowledge of 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.

She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and she is currently attaining her Masters in Biotechnology (Biodefense Concentration) at the Johns Hopkins University Advanced Academic Program.

Trainings by Expert

Product Stability Testing Program - Designing and Sustaining New and Existing Programs
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , Laboratory Compliance , 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) , 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) , 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 , 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 , 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 Clean Room 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