Why Should You Attend:
This 90-minute training will provide participants an understanding of:
The regulations guiding cleanroom facilities
What constitutes an effective design
Cleanroom classification
How a cleanroom validation should be structured
Routine monitoring of cleanrooms after the facility validation has been completed
Attendees will also gain an understanding of the different classifications and limits specific to the requirements stipulated by the USP, EU and ISO. The ways and types of materials of construction to be used within a cleanroom during the design and construction for an effective design and continuous contamination control will also be discussed.Areas Covered in the Webinar:
Module#1 (Basics Background of a Cleanroom Regulation, Classification and Design)
Summary of the Regulations Guiding Cleanroom Technology, Design and Validation
Types of Cleanroom Classifications and Requirements
EU Vs. ISO Vs. USP Requirements and Classification
Types and Sizes of Cleanroom Particles
Typical Uses of Various Levels of Cleanroom Classifications
How to Ensure an Effective Design of a Cleanroom
Initial Consideration and Roles
What Constitutes an Effective Cleanroom Design
What Materials of Construction to Use in the Design
Specific Design Concept Applicable to Processes
Planning a Cleanroom Design
Who Should be Involved/Roles
Process Steps in the Design of a Cleanroom
Module#2 (Cleanroom Cleaning Validation, Routine Monitoring and Excursion Investigation)
Summary of Cleanroom Validation Process
Process Steps Applicable to Cleanroom Validation
Cleanroom Facility Validation Protocol-Content
Cleanroom Validation Report-Content
Role of Various Departments During the Validation Process
Facility Engineers in the Process
Validation in the Process
Quality Control in the Process
Quality Assurance in the Process
Utilizing Cleanroom Validation Data for Routine Environmental Monitoring Program
Routine Environmental Monitoring Programs Applicable to Cleanroom
Testing Types
Typical Cleanroom Environmental Monitoring Excursions
Investigating and Correcting Cleanroom Environmental Monitoring Excursions
Module#3 (Contamination Control and Disinfection Processes)
Cleanroom Contamination Control and Disinfection Processes
Mitigating Particulate Contaminants
Cleanroom HEPA Filtration
Cleanroom Cleaning, Sanitization and/or Disinfection Process
Other Best Practices - Control of Cleanroom Contaminants:
Cleanroom Personnel Training
Basic Aseptic Practices
Gowning Practices and Personnel Qualification
Personnel Cleanroom Behavior
Question and Answer Session
This 90-minute training will provide participants an understanding of:
The regulations guiding cleanroom facilities
What constitutes an effective design
Cleanroom classification
How a cleanroom validation should be structured
Routine monitoring of cleanrooms after the facility validation has been completed
Attendees will also gain an understanding of the different classifications and limits specific to the requirements stipulated by the USP, EU and ISO. The ways and types of materials of construction to be used within a cleanroom during the design and construction for an effective design and continuous contamination control will also be discussed.Areas Covered in the Webinar:
Module#1 (Basics Background of a Cleanroom Regulation, Classification and Design)
Summary of the Regulations Guiding Cleanroom Technology, Design and Validation
Types of Cleanroom Classifications and Requirements
EU Vs. ISO Vs. USP Requirements and Classification
Types and Sizes of Cleanroom Particles
Typical Uses of Various Levels of Cleanroom Classifications
How to Ensure an Effective Design of a Cleanroom
Initial Consideration and Roles
What Constitutes an Effective Cleanroom Design
What Materials of Construction to Use in the Design
Specific Design Concept Applicable to Processes
Planning a Cleanroom Design
Who Should be Involved/Roles
Process Steps in the Design of a Cleanroom
Module#2 (Cleanroom Cleaning Validation, Routine Monitoring and Excursion Investigation)
Summary of Cleanroom Validation Process
Process Steps Applicable to Cleanroom Validation
Cleanroom Facility Validation Protocol-Content
Cleanroom Validation Report-Content
Role of Various Departments During the Validation Process
Facility Engineers in the Process
Validation in the Process
Quality Control in the Process
Quality Assurance in the Process
Utilizing Cleanroom Validation Data for Routine Environmental Monitoring Program
Routine Environmental Monitoring Programs Applicable to Cleanroom
Testing Types
Typical Cleanroom Environmental Monitoring Excursions
Investigating and Correcting Cleanroom Environmental Monitoring Excursions
Module#3 (Contamination Control and Disinfection Processes)
Cleanroom Contamination Control and Disinfection Processes
Mitigating Particulate Contaminants
Cleanroom HEPA Filtration
Cleanroom Cleaning, Sanitization and/or Disinfection Process
Other Best Practices - Control of Cleanroom Contaminants:
Cleanroom Personnel Training
Basic Aseptic Practices
Gowning Practices and Personnel Qualification
Personnel Cleanroom Behavior
Question and Answer Session
Speakers
Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies.She has been a much sought after SME to assume key roles specifically related to remediation and difficult quality and compliance related deficiencies associated with FDA’s Consent Decree, FDA’s Warning Letters and other regulatory bodies’ inspectional findings. Her remediation work has constantly resulted in several successful national and international regulatory bodies’ inspections, re-inspections and new product approvals.
Her technical expertise covers and goes beyond interpretation, administration and set up of quality assurance, quality/compliance, quality engineering, aseptic processing, contamination control, quality control, microbiology, sterility assurance, stability, vaccine development, new product design, product release testing and medical device sterilization (ethylene oxide (EtO), gamma, radiation, VHP sterilization) systems and operations for compliance to various regulations.
She has a keen working knowledge of the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization and post-approval inspections.
She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and she is currently attaining her Masters in Biotechnology (Biodefense Concentration) at the Johns Hopkins University Advanced Academic Program.
