Sterility Failure Investigations – A Step-by-Step Process for Success

Teachers
Danielle DeLucy
Category:
Manufacturing & Good Manufacturing Practices (GMP) Training/ On-Demand Courses/ Quality/ Regulatory & Compliance/ Research & Development/
Duration: 90-Minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include: water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, and the general manufacturing environment. As such, there is no one size fits all investigation.

Microbiological testing covers a wide range of products, processes and environments, therefore representative samples from each of these categories forms the basis of what gets investigated. The role of QC Microbiology in the identification and investigation of various results from manufacturing areas and finished product testing is extremely important.

When the need for an investigation arises, it is common for a cross functional team to convene involving all levels of management from various departments:

  • Quality Control Chemistry & Microbiology
  • Manufacturing
  • Quality Assurance
  • Facilities & Engineering

One of the important elements of the investigation is to decide which failing result comes from the appropriate category: product, process or environment. Once you determine where the failure has occurred, the investigation begins into finding out why it failed and how to correct it.

LEARNING OBJECTIVES

This course will describe the actions that should be taken when a sterility test failure occurs. What happens when a suspect microbial result is reported? What does it look like, and how should you react? This webinar will review when it is appropriate to investigate a result that may seem “out of the ordinary.”

By attending this interactive, 90-minute session, you will learn:

  • FDA Regulations and Guidance on Sterility Failure Investigations
  • Stages of Investigation: Lab Investigation vs. Manufacturing Investigation
  • Tools to use to help determine Root Cause
  • How to categorize sterility results
  • How to address impact to lots affected
  • Areas, parameters and variables to investigate as part of the investigation
  • Proper documentation of the Investigation
  • CAPA plans that address root cause

Who Should Attend

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

WHO SHOULD ATTEND

This course will be of benefit to anyone working in a GMP regulated environment on global or domestic scale that is responsible for – or affected by – Sterility control and deviations. This includes the following personnel:

  • QA and Manufacturing staff and management
  • QC Lab personnel
  • Microbiologists

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Danielle DeLucy
Danielle is a subject matter expert specializing in quality assurance and quality systems. She assists companies facing warning letters and consent decrees as well as those wishing to improve GxP practices and establish more robust quality systems.

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