Attend this webinar to understand the Clean Room regulations, design, classification, sources and types of particles. Learn how to create a common ground between these varying regulations and requirements. It will discuss the types of micro-organisms, routine monitoring processes, and typical mitigation steps to effective contamination control.
Why Should You Attend:
This 90-minute accredited training will offer a basic understanding of the Clean Room regulations, design, classification, sources and types of particles. The different classifications and limits for Clean room particles as it applies to various regulatory bodies’ and requirements (US, EU and ISO) will be addressed. Special attention will be given to understanding how to create a common ground between these varying regulations and requirements will be discussed. The types of micro-organisms, routine monitoring processes, typical mitigation steps in ensuring an effective contamination control through monitoring, sanitization, cleaning, personnel training, gowning, and material, product and personnel flow during a clean room operation will be addressed.
Areas Covered in the Webinar:
Module#1 (Basics, Background and Clean room Classification)
1.Summary of the Regulations Guiding Clean room Technology, Design and Verification
2.Types of Clean room Classifications and Requirements
3.Types and Sizes of Clean room Particles
4.Typical Uses of Various Levels of Clean room Classifications
5.Ensuring an Effective Design of Clean rooms
Module#2 (Basics of Microbiology, Sources of Contaminants and Contamination Control)
1.Clean room Microbes and Microbial Growth:
2.Sources of Clean room Particulate Contaminants
3.Contamination Control and Disinfection Processes within Clean rooms
4.Cleanroom HEPA Filtration
5.Cleanroom cleaning, sanitization and/or disinfection process
6.Other Best Practices - Control of Clean room Contaminants:
7.Cleanroom Personnel Training
8.Basic Aseptic Practices
9.Gowning Practices and Personnel Qualification
10.Personnel Clean room behavior
Module#3 (Cleanroom Cleaning Validation, Routine Monitoring and Investigation)
2.Process steps applicable to clean rooms
3.Routine Monitoring Programs Applicable to Cleanroom Particulates
Question and Answer Session
Who Will Benefit:
This webinar will provide a great resource to personnel involved within the following departments in the Pharmaceutical, Biotechnology, Diagnostics, Drugs, Cell Therapy, Biologics and Medical Device industries:
However, if you are already familiar with how to achieve an effective Clean room technology and contamination control, you may recommend this webinar to anyone in your company that may require additional knowledge about this subject.
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
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.