Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

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

Description

COURSE DESCRIPTION

OVERVIEW

Compounded sterile products are made utilizing aseptic technique.  Aseptic technique is a microbiological term referring to the prevention of microorganism contamination.  Most importantly, this activity is critical for the successful manufacture of safe and sterile therapeutics. The procedure involves the use of specialized equipment, sterile apparel, meticulous processing, and continuous cleaning.  However, this technique is often overlooked by firms and staff leading to sloppy production caused – most often – by human error.

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

LEARNING OBJECTIVES

If you and your colleagues want to learn simple steps to improve your efforts, then join our interactive online training course where you will learn:

  1. Definition of aseptic processing (AP)
  2. Terminal sterilization vs. AP
  3. Proper personnel behavior in a cleanroom – keeping human error out of the equation
  4. Facility design and how it impacts the product – mitigating risks, reaping reward
  5. A review of proper environmental monitoring practices and systems used
  6. Aseptic technique & clean room behavior – the final word

In addition, this course will review 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 will benefit aseptic operators, aseptic sample handlers, personnel who work in a Biological Safety Cabinet (BSC), plus 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.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Danielle DeLucy
Assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

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