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, the host will also review how quality systems helps in defining requirements for cleanrooms / aseptic technique, and how these environments should be to properly maintained.
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
Speakers
Danielle DeLucy,
Owner ,
ASA Training and Quality Consulting LLCDanielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy 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.
Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, 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 lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.
Who Should Attend
- Aseptic Operators
- Quality Assurance Departments
- Manufacturing Departments
- Microbiology Quality Control Departments
