Guideline to Aseptic Technique and Clean Room Behavior

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Category online training courses for hr professionals,online training programs for hr professionals, HR Training and Development

Deadline: March 26, 2019 | Date: March 26, 2019

Venue/Country: Online Event, U.S.A

Updated: 2019-02-28 16:07:40 (GMT+9)

Call For Papers - CFP

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 in the Session

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

Learning Objectives

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

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

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.

Event link: https://www.traininng.com/webinar/-200811live?channel=ourglocal-march_2019_SEO

Contact Info

Traininng.com LLC

Email: traininngdotcomgmail.com

Phone: US: (510) 962-8903

Phone: Zurich: +41 - 43 434 80 33

Website : https://www.traininng.com