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)
Summary of the Regulations Guiding Clean room Technology, Design and Verification
Types of Clean room Classifications and Requirements
EU Requirements and Classification
USP Requirements and Classification
ISO Requirements and Classification
Bridging the Gap between the various Regulatory Bodies’ and Requirements
Types and Sizes of Clean room Particles
Typical Uses of Various Levels of Clean room Classifications
Ensuring an Effective Design of Clean rooms
Module#2 (Basics of Microbiology, Sources of Contaminants and Contamination Control)
Clean room Microbes and Microbial Growth:
Bacteria as a Clean room Contaminant
Mold as a Clean room Contaminant
Sources of Clean room Particulate Contaminants
Sources of clean room particles contamination
Typical settling rates of particles contaminants within clean rooms
Contamination Control and Disinfection Processes within Clean rooms
Mitigating particulate contaminants
Cleanroom HEPA Filtration
Cleanroom cleaning, sanitization and/or disinfection process
Other Best Practices - Control of Clean room Contaminants:
Cleanroom Personnel Training
Basic Aseptic Practices
Gowning Practices and Personnel Qualification
Personnel Clean room behavior
Module#3 (Cleanroom Cleaning Validation, Routine Monitoring and Investigation)
Cleaning Validation
Summary of cleanroom qualification processes
Process steps applicable to clean rooms
Understanding the importance and utilizing the data from clean room cleaning validation
Monitoring Cleaning Procedure Effectiveness
Routine Monitoring Programs Applicable to Cleanroom Particulates
Testing Types
Typical cleanroom deviations and environmental monitoring excursions
Investigating and correcting deviations and environmental monitoring excursions
Question and Answer Session
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)
Summary of the Regulations Guiding Clean room Technology, Design and Verification
Types of Clean room Classifications and Requirements
EU Requirements and Classification
USP Requirements and Classification
ISO Requirements and Classification
Bridging the Gap between the various Regulatory Bodies’ and Requirements
Types and Sizes of Clean room Particles
Typical Uses of Various Levels of Clean room Classifications
Ensuring an Effective Design of Clean rooms
Module#2 (Basics of Microbiology, Sources of Contaminants and Contamination Control)
Clean room Microbes and Microbial Growth:
Bacteria as a Clean room Contaminant
Mold as a Clean room Contaminant
Sources of Clean room Particulate Contaminants
Sources of clean room particles contamination
Typical settling rates of particles contaminants within clean rooms
Contamination Control and Disinfection Processes within Clean rooms
Mitigating particulate contaminants
Cleanroom HEPA Filtration
Cleanroom cleaning, sanitization and/or disinfection process
Other Best Practices - Control of Clean room Contaminants:
Cleanroom Personnel Training
Basic Aseptic Practices
Gowning Practices and Personnel Qualification
Personnel Clean room behavior
Module#3 (Cleanroom Cleaning Validation, Routine Monitoring and Investigation)
Cleaning Validation
Summary of cleanroom qualification processes
Process steps applicable to clean rooms
Understanding the importance and utilizing the data from clean room cleaning validation
Monitoring Cleaning Procedure Effectiveness
Routine Monitoring Programs Applicable to Cleanroom Particulates
Testing Types
Typical cleanroom deviations and environmental monitoring excursions
Investigating and correcting deviations and environmental monitoring excursions
Question and Answer Session
Speakers
Charity Ogunsanya has over 26 years of extensive experience within the Pharmaceutical, Biotechnology, Biologics, Cell-Therapy, Diagnostics, Research and Development, Radio-pharmaceutical, Contract Manufacturing Organization (CMO) and Medical Device companies.Throughout her corporate career within these diverse industries, she held various high visibility and business critical roles within the Quality and Compliance division in major Fortune 100 companies both as a Subject Matter Expert (SME), Site Manager, Multi-site Manager and Director Levels receptively. She has been a sought after expert and have been consistently hired after several competitive efforts by major fortune 100 companies 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 difficult regulatory bodies inspectional findings which is always achieved with a successful outcome. She has also been a sought after expert by various companies requesting her expertise as a known industry expert to specifically assume roles in order to perform a total overhaul, restructure, compliance remediation, re-organization, start-up processes related to Quality Systems improvements and/or enhancements. In all cases, her remediation work resulted in several successful National and International regulatory bodies’ inspections, re-inspection and new product approvals.
Her technical expertise are not limited to the 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.
Ms. Ogunsanya is vast in 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. Her expertise has been sought after by several Fortune 100 Pharmaceutical, Biotechnology, Biologics and Medical Device companies as a Quality and Compliance SME during critical national and international regulatory bodies’ routine and new product approval inspections.
She is the CEO of Pharmabiodevice Consulting LLC (www.pharmabiodeviceconsultant.com) targeted towards Quality and Compliance related remediation, enhancements and consultant services for various companies within the industry. She is a well sought after high level consultant for several international professional expert networks such as Gerson Lehrman Group, Zintro Expert Network and Intota Expert Network. She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network.
