Live Webinar Understanding Aseptic Technique and Cleanroom Behavior

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate by the speaker ,Q/A and 60 mins Live Webinar

"Hear by Danielle DeLucy Principal/Owner, ASA Training & Quality Consulting, LLC"

Aseptic technique, in sterile compounding, contributes in preventing microbiological contamination.

Description

 Aseptic technique is being used to provide safety, efficacy and sterility to the products that are sterile in nature, especially when it comes to various patient injections.

This course by expert speaker Danielle DeLucy 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.

Cleaning, Gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are. 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.

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 Cleanrooms are designed for proper contamination control.

Areas Covered

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.

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.

Industries who can attend

Key Learning Objectives of your Topic:

•    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


Speaker Profile

Danielle DeLucy

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy has been in the industry for 15 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.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, 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 lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she 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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