Online Webinar 2019 - Live Webinar Understanding Cleanroom Microbiology – Building A Foundation For Compliance
Topics/Call fo Papers
Overview
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.
Session Highlights
• 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 Should Attend
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.
Your Expert Instructor
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, 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 and consent decrees establish more robust quality systems so that the company can succeed.
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.
Session Highlights
• 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 Should Attend
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.
Your Expert Instructor
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, 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 and consent decrees establish more robust quality systems so that the company can succeed.
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Last modified: 2019-08-29 15:21:33