Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
Added by Referral on 2019-07-30
Conference Dates:
Start Date: 2019-09-10Last Day: 2019-09-11
Conference Contact Info:
Contact Person: Ashutos SwainEmail: [email protected]
Address: Venue to be announced shortly, Philadelphia, PA, 19019, United States
Tel: 8887172436
Fax: +1-650-362-2367
Conference Description:
Learning Objectives:Discuss Cleanroom Classification, Regulations and Guidelines
Summarize how to Perform Cleanroom Design, Validation/Qualification, Operation, Environmental Monitoring Program and ensuring a state of control
Describe Aseptic Practices, Personnel Health Practices, Gowning and Trafficking Patterns in a Cleanroom
Establish and describe the Requirements of Cleanroom Cleaning/Disinfection and Contamination Control Practices
Summarize various Sterilization Processes, Advantages and Disadvantages –both Physical and Chemical
Describe the Sterilization Processes and Controls
Who will Benefit:
This training will benefit those involved in the manufacturing, processing, testing and release of sterile and non-sterile products. It will provide the attendee an understanding of the basic concept of microbiology, microbiological and contamination control practices, cleanroom design, routine testing, qualification/validation and use of cleanrooms as well as the typical sterilization processes (Physical and Chemical) within various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries, especially personnel and management in:
Quality Assurance
Quality Control
Manufacturing
Validation
Supplier Quality Assurance
Regulatory Affairs
Shipping and Receiving
Facility and Maintenance
Engineering
Materials Management
Analysts
Analytical Chemists
All levels of management
Microbiologists