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Event :Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

Date :Wednesday February 20th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

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

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

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
    • 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

Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes Management
sterility failure investigation training program, usp <71>, sterility failure notification process, personnel handling and cleanroom behavior, environmental monitoring, microbial identification of contaminant" /> <meta name="google-site-verification" content="xdtmmzpsgz_5ikkrz2hkxoofavrpmxjlvvq2qu2asfi
Professionals, 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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