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3-hr Virtual Seminar: Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

5029
Duration : 3 Hours

Danielle DeLucy, Pharmaceuticals, Biotechnology

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, suc Read more


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.

Course Objectives:

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.

Course Outline:

• 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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• QA and QC managers
• Disinfectant validation managers
• Operations managers
• Cleanroom managers
• Personnel and contractors that clean and disinfect cleanrooms
• EH&S managers
• Regulatory compliance managers and environmental monitoring managers
• Aseptic Operators
• Manufacturing Departments
• Microbiology Quality Control Departments

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : 3-hr Virtual Seminar: Aseptic Technique and Cleanroom Behavior – Avoiding Human Error


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