3-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behavior - Avoiding Human Error

Danielle DeLucy
Instructor:
Danielle DeLucy
Date:
Friday, February 19, 2021
Time:
09:00 AM PST | 12:00 PM EST
Duration:
3 Hours

More Trainings by this Expert   Product Id : 503554

Price Details
$290 Live
$490 Corporate Live
$340 Recorded
$540 Corporate Recorded
Combo Offers
Live + Recorded
$549 $630 Live + Recorded
Corporate (Live + Recorded)
$799 $1030 Corporate
(Live + Recorded)
Price Detail Options
Overview:

Aseptic techniques are used to create compounded sterile products. In Microbiological term; Aseptic technique refers to prevention of microorganism contamination.

This activity is most important for successfully manufacturing safe and sterile therapeutics. Continuous cleaning, meticulous processing, sterile apparel and use of specialized equipment are involved in these procedures. However, by overlooking these techniques by staff and firms results in sloppy production mostly caused by human error.

Why you should Attend: It is paramount to success, especially for injectables and biologics that depend on the sterility, safety and efficacy of products and there is no room for mistakes.

During this course we will also review how quality systems helps in defining requirements for cleanrooms / aseptic technique, and how these environments should be to properly maintained.

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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