Understanding Aseptic Technique and Cleanroom Behavior

In this webinar speaker will explain about proper cleaning, gowning and ways to avoid the common sources of contamination that exist in a clean room environment.

Danielle DeLucy
Instructor:
Danielle DeLucy
Date:
Friday, August 9, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 502693

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
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Overview:

In sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It is providing sterility, safety, and efficacy to the sterile product, especially various injections for patients. Cleaning, Gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.

Why should you Attend: Compounding sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination. The procedure involves the use of specialized equipment, sterile apparel, meticulous processing, and continuous cleaning.

This course will review proper cleaning, gowning and ways to avoid the common sources of contamination that exist in a clean room environment. This course is also a good refresher for those personnel that are familiar with the way to properly work in the clean room and why clean rooms are designed for proper contamination control.

Areas Covered in the Session:

  • Definition of Aseptic Processing (AP)
  • Terminal Sterilization vs. AP
  • Proper Personnel Behavior in a Cleanroom
  • Facility Design and how it impacts the product
  • A review of proper environmental monitoring practices and systems used
  • Aseptic Technique & clean room behavior

Who Will Benefit:
  • This course will benefit those Aseptic operators, Aseptic sample handlers, personnel who work in a Biological Safety Cabinet (BSC) and their management and Quality Assurance counterparts, in highlighting how to operate in a clean room environment, proper facility design, proper personnel gowning, and the equipment needed to conduct environmental monitoring
  • In addition, this course will review how Quality Systems help define requirements for aseptic technique and clean rooms and how to properly maintain these environments


Speaker Profile
Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.




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