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

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.

 

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.

Seminar Agenda:

  • Definition of aseptic processing (AP)
  • Terminal sterilization vs. AP
  • Proper personnel behavior in a cleanroom – keeping human error out of the equation
  • Facility design and how it impacts the product – mitigating risks, reaping reward
  • A review of proper environmental monitoring practices and systems used
  • Aseptic technique & clean room behavior – the final word
Who Should Attend:

  • Aseptic Operators
  • Quality Assurance Departments
  • Manufacturing Departments
  • Microbiology Quality Control Departments

FDB3586

Danielle DeLucy

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 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.

membership

JUST RELEASED
SEMINARS
&
WORKSHOPS
 





  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.