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Langue du site : Français - English
Réf : 30415
Evènement :Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

Date :Jeudi 12 Septembre 2019

Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.

Objectives

  • Discuss the regulations guiding manufactured product sterility testing such as USP <71> Sterility Testing and how to ensure adherence to program testing requirements.
  • Step by step process in conducting sterility test failure investigation and what to look for during the entire investigation process.
  • Discuss the role of contaminant as a key tool during investigational process such as microbial identification of contaminant and if it is important or not important - why or why not?
  • Performing a product retest during a sterility failure investigation and how to apply corrective and preventative action based on the findings of a sterility failure investigation.
  • How to disposition impacted products based on investigational findings while avoiding common mistakes during product disposition.
  • Impact of sterility failure investigation for commercially distributed products under a stability testing program.

 

Program

  • 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
    • Training/Competencies
  • 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

Speakers

Charity Ogunsanya
Director of Quality Control, Pharmabiodevice Consulting LLC
 

Lieu

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

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Précisions

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes Pharmacie
"sterility failure investigation training program, usp <71>, sterility failure notification process, personnel handling and cleanroom behavior, environmental monitoring, microbial identification of contaminant"
Professionnels, This webinar will provide a great resource to personnel involved within the following departments in the pharmaceutical, Biotechnology, Diagnostics, Drugs, Cell therapy, Biologics, Raw material, Excipients, Chemicals and API suppliers, And medical device industries: Quality Control Sterility Assurance Manufacturing/Production Senior Management Raw Materials Tester Supplier Quality Regulatory Affairs Quality Assurance Compliance Design Engineers Facility, Maintenance and Engineering Contract Manufacturing Organizations (CMO) Active Pharmaceutical Ingredients Suppliers Chemical Suppliers Excipient Suppliers
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English

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