Understanding Aseptic Technique & Cleanroom Behavior: Avoiding Human Error

Teachers
Danielle DeLucy
Category:
Manufacturing (GMP)/ On-Demand Courses/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90 minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

The sterility, safety, and efficacy of your products is paramount to success, especially in injectables and biologics, there simply is no room for mistakes.

Compounded sterile products utilize aseptic techniques that prevent microorganism contamination. This activity is critical for the successful manufacturing of safe, sterile therapeutics. The procedure involves using specialized equipment, sterile apparel, meticulous processing, and continuous cleaning.  But often, this technique is overlooked by firms and staff, leading to sloppy production that is most often caused by human error.

LEARNING OBJECTIVES

During this interactive session, you will learn simple steps to improve your aseptic efforts and be able to:

  • Define aseptic processing (AP)
  • Stated the differences between terminal sterilization and AP
  • Identify the proper personnel behavior in a cleanroom to keep human error out of the equation
  • Describe facility design and how it impacts the product
  • Explain proper environmental monitoring practices and systems used

Finally, this course reviews how quality systems help define requirements for aseptic technique/cleanrooms, and how to properly maintain these environments.

Who Should Attend

WHO SHOULD ATTEND

This course benefits aseptic operators, aseptic sample handlers, and personnel working in a Biological Safety Cabinet (BSC).  This course also assists management and quality assurance staff by highlighting how to operate in a clean room environment.

Proper facility design, personnel gowning, and the equipment needed to conduct environmental monitoring are highlighted to give context, so those responsible for these areas are encouraged to attend.

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.
Contact us at 215-675-1800, Option 3 (9am – 5pm EST, Monday-Friday).

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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