Understanding Cleanroom Microbiology – Building A Foundation For Compliance

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Danielle DeLucy, MS, has been in the industry for 15 years serving in numerous Quality Management Roles"

Contamination control and clean room management

Description

This course provides practical information on contamination control and clean room 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
•     Clean room Design
•     Controlling Microbiological Contamination in the Clean room
•     Clean room Operations and Personnel Behavior
•     A review of environmental monitoring of the clean room

Who will Benefit

This course is designed for management and staff involved in clean room operations who will benefit from a better understanding of how microbiology impacts clean room operations.
•     The course focuses on basic microbiology
•     clean room 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

 


Speaker Profile

Danielle DeLucy

Danielle 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.

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