Guideline to Aseptic Technique and Clean Room Behavior

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

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

"Hear By 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"

Refresher for those personnel that are familiar with the way to properly work

Description

This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, 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

•           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 and Clean Room Behavior

Who will Benefit

This course will highlight 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. This course will benefit:

•           Aseptic operators
•           Aseptic sample handlers
•           Personnel who work in a biological safety cabinet (BSC) and their management
•           Quality assurance counterparts

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


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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