Cleanroom Behavior 2020 - Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
Topics/Call fo Papers
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.
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.
Definition of aseptic processing (AP)
Terminal sterilization vs. AP
Proper personnel behavior in a cleanroom – keeping human error out of the equation
Speaker:
Danielle DeLucy, MS, is currently the owner of ASA Training & Quality Consulting, LLC, an Independent Consultant Agency to the Biologics and Pharmaceutical Industries specializing in the areas of Quality Assurance and Quality Systems.
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.
Definition of aseptic processing (AP)
Terminal sterilization vs. AP
Proper personnel behavior in a cleanroom – keeping human error out of the equation
Speaker:
Danielle DeLucy, MS, is currently the owner of ASA Training & Quality Consulting, LLC, an Independent Consultant Agency to the Biologics and Pharmaceutical Industries specializing in the areas of Quality Assurance and Quality Systems.
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- A Critical Step in Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
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Last modified: 2020-10-14 18:58:44