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Langue du site : Français - English
Réf : 31586
Evènement :Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

Dates :Lundi 25 Mai 2020 - Mardi 26 Mai 2020

Lieu :Dallas, Texas, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

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.
 

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


 

Program

Day 01(8:30 AM - 5:00 PM)
  • 08.30 AM - 09.00 AM: Breakfast and introduction
  • 9:00 AM – 11:00 AM: Module 1
    • Cleanroom Guidelines, Regulations and Definitions
    • Summary of Key Areas of Cleanroom Technology and Classifications
    • Define the EU, ISO and USP Recommended Limits for Microbial Contamination
    • Cleanroom Design and Initial Design Considerations
    • Cleanroom Design Guidelines - Facility Layout, Airlocks or Anteroom, Windows and Speaking Diaphragms, Pass-through and Gowning Rooms
    • Cleanroom Design Guidelines - Cleanroom Location, Make-up Air, Cleanroom Walls- Seamless, Non-porous Surface
  • 11:00 AM – 11:15 AM: Break
  • 11:15 AM – 12.00 PM: Module 2
    • Review Cleanroom Design Guidelines (Material of Construction for Cleanroom Ceilings), Cleanroom Doors and Cleanroom Floors
    • Discuss the Design Guidelines (HVAC & Filtration Systems) and the types of Cleanroom Airflow
  • 12:00 PM – 01:00 PM: Lunch Break
  • 01:00 PM – 02.30 PM: Module 2
    • Summary of the principles and regulations guiding Cleanroom Validation (OQ/PQ) and Operation testing
    • Performing Cleanroom Effectiveness Verification Tests and utilizing Cleanroom Cleaning Validation Data in a PQ Process
    • Designing a Cleanroom Performance Qualification (PQ) Protocol and Report
    • Applying the Fundamentals of Environmental Monitoring (EM) Program, Limits, Requirements, Excursion Investigation and Data Trending
    • Perform a correlation between Contamination Control and Environmental Monitoring
    • Understand the Causes of Adverse Trends
  • 02:30 PM – 02:45 PM: Break
  • 02:45 PM – 04.00 PM: Module 3
    • How to Use the principles of Aseptic Practice regulation to set up an Aseptic Environment and for the manufacturing of a product
    • Cleanroom Practices - Personnel Health and Cleanliness, Personnel Practices (Sterile Gloves, Sterile Gowns and Operator Technique)
    • Step-wise approach in performing workstation and Equipment Cleaning and Disinfection
    • Process flow/Trafficking Patterns for Equipment, Materials, Personnel, Supplies and Waste within a Cleanroom
  • 04:00 PM – 05.00 PM: Question and Answers
Day 02(8:30 AM - 5:00 PM)
  • 08:30 AM – 09:00 AM: Breakfast
  • 09:00 AM – 11.00 AM: Module 1
    • Cleaning/Disinfection Program Guidance and Regulations
    • The Basics of Microbiology and Contamination Control and Mitigation
    • GMP Cleanroom Cleaning and Primary Cleanroom Contaminants
    • Cleanroom Gowning Guide, Garment Recommendations, Gowning/Degowning and Requirements by ISO Classification
  • 11:00 AM – 11:15 AM: Break
  • 11:15 AM – 12.00 PM: Module 2
    • Sterilization Processes and Methods (Physical and Chemical)
    • Terminologies and factors influencing Thermal (Heat) Sterilization
    • Examples of Dry Heat Sterilization (Hot air oven, Flaming (AKA Red Hot Sterilization), Incineration, Dry Heat Tunnels, Infra-red Radiation
    • Moist Heat Sterilization and Examples - Pasteurization, Boiling, Tyndallization, Autoclave/Steam Sterilizer.
  • 12:00 PM – 01:00 PM: Lunch Break
  • 01:00 PM – 02.30 PM: Module 2
    • Advantages and Disadvantages of various types of dry heat and moist heat sterilization processes
    • How to Differentiate between Ionizing and non-ionizing Radiation including microwave Radiation, Ultraviolet Radiation, Gamma Rays/Gamma Sterilization
    • Use and Disadvantages of Ionizing Radiation-Gamma Radiation
    • Chemical Sterilization Methods using various types of liquid sterilants such as Phenolic , Hydrogen Peroxide, Halogens, Chlorine and Alcohols, Heavy Metals, Quatenary, Peroxygens and Aldehydes
  • 02:30 PM – 02:45 PM: Break
  • 02:45 PM – 03.45 PM: Module 3
    • Chemical Sterilization using Gaseous Method such as Ethylene Oxide, Formaldehyde and Glutaraldehyde Sterilization
    • Sterilization by Filtration and various types of Filters
    • Monitoring of Sterilization Processes using Mechanical and internal chemical Indicators
    • Routine Monitoring of Steam Sterilizers and Ethylene Oxide Sterilizers - Bowie Dick Type Tests and Test Results
    • Installation & Repair Testing and Sterilization Process Monitors
  • 03:45 PM – 04.45 PM: Review of case studies
  • 04:45 PM – 05.00 PM: Question and Answers

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.


 

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Précisions

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers Pharmacie
cleanroom regulations, cleanroom classifications, cleanroom design considerations, cleanroom qualification, cleanroom cleaning validation ioq/pq, cleanroom routine monitoring and excursion investigation, cleanroom environmental monitoring program, environmental monitoring program
Professionnels
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