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

Aseptic techniques, the shield against microorganism contamination, are pivotal in the creation of safe and sterile therapeutics. Our course illuminates the critical role of continuous cleaning, meticulous processing, sterile apparel, and specialized equipment in ensuring impeccable production standards. Neglecting these techniques leads to sloppy production, often due to human error, jeopardizing the sterility, safety, and efficacy of injectables and biologics. Our training emphasizes the non-negotiable importance of flawless execution in this realm.

Discover how quality systems define the prerequisites for cleanrooms and aseptic techniques, and learn the art of maintaining these environments to perfection. Join this course to master the art and science of aseptic techniques, safeguarding the integrity of your products and paving the way for unparalleled success in the pharmaceutical landscape.

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

Course Director: 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.