This course will educate you about various key elements of STERILITY
ASSURANCE AND CONTAMINATION CONTROL SUCH AS CLEANROOM REGULATIONS,
Classification, Sources and types of particles, Design Requirements,
Validation/Qualification, Operations, Environmental Monitoring Program
requirements, Excursion investigations, DataTrending, Microbiological
processes/methodology, CLEANROOM CLEANING/disinfection. The types of
micro-organisms, typical mitigation steps in ensuring an effective
contamination control through Personnel Training (Aseptic PRACTICES,
CLEANROOM BEHAVIOR AND CONTAMINATION CONTROL PROCEDURES),Gowning
Controls, Personnel Training, CLEANROOM TRAFFICKING (CLEANROOM
PERSONNEL MATERIAL, Product and Equipment Transfer PRACTICES AND
TRAINING (Entry and Exit Policy), CLEANROOM GOWNING, Contamination
Control, Cleaning and Disinfection Program and the Basics of
Sterilization Processes- Physical and Chemical Processes will also be
discussed. The various regulatory bodies’ requirements such as 21
CFR Part 211 (mostly relevant 211.113 “Control of microbiological
contamination”, ISO 14644 (Various Parts), FDA Guidance for
Industry: Sterile Drug Products Produced By Aseptic Processing -
Current Good Manufacturing Practice”) amongst others and the
criticality of aseptic processing and other key contamination control
evaluators during the manufacture and testing of products are
important to the quality determination and release of the finished
manufactured products. 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 FOR REGISTRATION :
https://www.complianceonline.com/cleanroom-microbiology-sterility-assurance-practices-drug-device-manufacturers-seminar-training-80618SEM-prdsmchannel=referral_ticketleap
[https://www.complianceonline.com/cleanroom-microbiology-sterility-assurance-practices-drug-device-manufacturers-seminar-training-80618SEM-prdsm?channel=referral_ticketleap]
Seminar One Registration - $1999.00
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06/12/2019 Last update