This course provides practical information on contamination control and cleanroom management. Information is presented for the critical daily aseptic maintenance and housekeeping functions necessary to maintain required cGMP cleanliness levels.
Areas Covered
- Elements of Basic Microbiology
- Cleanroom Design
- Controlling Microbiological Contamination in the Cleanroom
- Cleanroom Operations and Personnel Behavior
- A review of environmental monitoring of the cleanroom
Please Note:
Recorded Version will be available within 24 hours after completion of the live Webinar and will allow unlimited viewing for 3 months.
CD Version can be dispatched after 72 hours on completion of live Webinar.
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
Who will Benefit
This course is designed for management and staff involved in cleanroom operations who will benefit from a better understanding of how microbiology impacts cleanroom operations.
- The course focuses on basic microbiology
- cleanroom standards
- cleaning, monitoring
- operating procedures
Industries who can attend
This 90-minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel
