Understanding Aseptic Technique and Clean room Behaviour

Product Id : FDA25
Instructor : Danielle DeLucy
Jun 23, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Description:

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.

Session Highlights:

This environmental control in pharmaceutical industry webinar is a good refresher for those personnel that are familiar with the way to properly work in the clean room and why environmental control rooms are designed for proper contamination control.

Key Objective of 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 keeping in mind FDA audit training, FDA CGMP compliance and FDA environmental monitoring, along with why clean rooms are designed the way they are.

  • 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

Target Audience:

  • Aseptic operators
  • Aseptic sample handlers
  • Personnel who work in a Biological Safety Cabinet (BSC) and their management
  • Quality Assurance counterparts,
  • 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,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 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. 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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