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Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes - Webinar (Recorded)

  • Webinar

  • 120 Minutes
  • September 2019
  • Compliance Online
  • ID: 4899962
Why Should You Attend:

This training session will provide an understanding of the regulations guiding the sterility testing program and the process of conducting an effective, robust and compliant sterility test investigation for various types of sterile products. Attendees will gain an understanding of:

The step by step investigational tool to apply when conducting sterility test failure investigation.
How to delineate between a probable and an affirmative root cause using the recovered contaminant based on the investigational findings.
Possible corrective and preventative actions and how to apply the results of the investigation (investigational findings) to other manufactured batches of products within the same cleanroom.
Disposition of the manufactured batch of product with a failed sterility test result, regulatory guidelines associated with a retest of the affected batch and handling a sterility failure associated with a commercially distributed product under stability testing program.
The content of a sterility test investigation form to provide robustness to an investigational process will be shared with the attendees as a tool that may be used when designing a sterility failure investigation program.

Areas Covered in the Webinar:

Module#1 (Requirements of a Sterility Testing Program and Initial Consideration during a Sterility Failure Investigation)

Regulations Guiding Manufactured Product Sterility Testing
USP < 71> Sterility Testing
Ensuring Adherence to Program Testing Requirements
Aseptic Processing
Contamination Control
Appropriateness of Testing Facility
Appropriateness of Testing Personnel
Initial Considerations During a Sterility Test failure Investigation
Affected Departments and Roles
Role of Quality Control
Role of Quality Assurance
Role of Manufacturing or Operations
Role of Facility or Engineering
Role of Regulatory Affairs
The Sterility Failure Notification Process
Initial Documentation Process during an Investigation
What Happens to the Affected Product Batch
Handling Affected Batch (or Batches) of the Product
Module#2 (Step by Step Process of Conducting an Effective, Robust and Compliant Sterility Test Failure Investigation)

Step by Step Process In Conducting Sterility Test Failure Investigation
What to Look for During the Investigational Process
Role of Personnel Handling and Cleanroom Behavior
Role of Testing Materials, Equipment and Media
Role of Environmental Monitoring or Testing
Role of Disinfection and Practices
Role of Testing Facility
Role of Laboratory Environment (Incubation)
Role of Training
Role of Environmental Controls
Role of Classified Testing Locations
Role of Room and Materials Qualification (Various)
Role or Microbial Identification
Role of Previous Product Sterility Test Failure Trends and Reports
Role of Previous Trends and Reports
Other Important Aspects
Role of Contaminant as a Key Tool During Investigational Process
Microbial Identification of Contaminant
Important or Not Important? Why or Why Not
Using a Process Map of Contaminant as a Tool for Root Cause Analysis
How to Utilize Identified Contaminant to Perform a Sterility Test Failure Investigation
Root Cause Analysis Process
Most Probable Root Cause versus Final Root Cause
Module#3 (Effective a Robust Corrective Actions, Preventative Actions, Sample of Investigation Forms, Product Disposition Process and Avoiding Common Mistakes)

Sample of Sterility Failure Investigation Forms
Important Sections
Effective Investigational Tools
Performing a Product Retest During a Sterility Failure Investigation
Regulatory Requirements Applicable to Product Retest
When to Perform a Product Retest
When not to Perform a Product Retest
Applying Corrective and Preventative Action Based on Findings of a Sterility Failure Investigation
Appropriateness of the Corrective Action
Appropriateness of the Preventative Action
Examples of Corrective And Preventative Actions
Disposition of the Products Based on Investigational Findings
How to Determine a False Positive Result
Dispositioning Products After a Sterility Failure Investigation
Avoiding Common Mistakes During Product Disposition
Role of QA
What Happens After Product Disposition
Impact of Sterility Failure for Commercially Distributed Products under a Stability Testing Program
Commercial Impact-Product Out in the Market
What Happens Next if a True Contamination or Failure is Discovered
Role of Regulatory Affairs
Agency Notification Process
Avoiding Common Mistakes During
When not to Ignore - An Early Warning Sign of a Systemic Issue
When not to Ignore - An Effective Implementation of Adequate Corrective Action and Preventative Action


Charity Ogunsanya has over 26 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.