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HomeManufacturing (GMP)Aseptic Process Simulations – A Comprehensive Guide for Proper Execution

Aseptic Process Simulations – A Comprehensive Guide for Proper Execution

Teachers
Danielle DeLucy
Category:
Manufacturing (GMP)/ On-Demand Courses/ Quality/ Regulatory & Compliance/ Research & Development/
inspection
Clear
Duration: 90-Minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

Aseptic processing, the technique used to ensure sterile drugs are packaged in sterile containers, is one of the most important steps in biopharmaceutical manufacturing, because of the risk that contamination poses to patient safety.

An Aseptic Process Simulation is performed by these biopharmaceutical firms to ensure the process can be performed with minimal contamination. This is accomplished by using growth medium instead of the actual product in the processing steps.

Regulators look for these Aseptic Processing Simulations or Media Fills, as they are sometimes called, to demonstrate control of the process and also the operators executing the tasks. These simulations must be done periodically and with the knowledge of the regulations that govern them.

This course will help those using APS/media fills to determine their risks of contamination in the process and how they can prevent it. A complete review of what elements need to be included in the APS design will be discussed, which includes: frequency of performance, number of operators, what types of growth media to use, how slow or fast the filling line needs to operate and how to read the units after they have been incubated.

LEARNING OBJECTIVES

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

  • The current regulatory requirements for Aseptic Process Simulations (APS)
  • The elements of a successful APS (interventions, worst case conditions, etc.)
  • How to use an APS to qualify operators
  • What types of risk exist that could cause contamination in your process
  • How to properly examine the units once incubated

Who Should Attend

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:

  • Lab managers
  • Regulatory personnel
  • Quality control analysts and QA professionals
  • Manufacturing operators
  • Sterility assurance professionals

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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Clear
Duration: 90-Minutes
On-Demand
Includes handouts

CATEGORIES

  • Coronavirus / COVID-19 (4)
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Upcoming Live Courses

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