Advanced HVAC & GMP Compliance: Environmental Control for Pharmaceutical Cleanrooms

Is Your Cleanroom HVAC Ready for the Future?

Instructor :
Roger Cowan

Webinar ID:
11562

Date: NOV 25, 2024 (MON)

Start Time: 10 AM PT - 11:30 AM PT

Duration: 90 Mins.

What will you learn

    • Regulatory Cleanroom Classification And GMP Compliance Requirements
    • Cleanroom Design, Layout, And HVAC System Components
    • HEPA Filtration And Airflow Management Techniques
    • Differential Pressure And Air Pressure Balancing Essentials
    • Temperature And Humidity Control Strategies
    • Non-Viable Particulate And Microbial Monitoring Systems
    • Personnel Gowning And ….
    • Regulatory Cleanroom Classification And GMP Compliance Requirements
    • Cleanroom Design, Layout, And HVAC System Components
    • HEPA Filtration And Airflow Management Techniques
    • Differential Pressure And Air Pressure Balancing Essentials
    • Temperature And Humidity Control Strategies
    • Non-Viable Particulate And Microbial Monitoring Systems
    • Personnel Gowning And Aseptic Practices For Cleanrooms
    • Cleaning, Disinfection, And Effective Sanitization Procedures
    • HVAC System Validation And Ongoing Environmental Monitoring

Course Description

Environmental control in pharmaceutical cleanrooms is critical to ensuring the production of high-quality products. Maintaining and monitoring key factors such as airborne particulates, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is essential to prevent contamination.

This course covers:

    • Design, validation, and monitoring of cleanroom HVAC systems.
    • Compliance with international regulatory standards.
    • Best practices for maintaining cleanroom integrity.
    • Testing requirements for a compliant cleanroom environment.

By attending this training, participants will:

    • Gain a comprehensive understanding of cleanroom environments.
    • Learn the latest HVAC strategies to ensure product safety and quality.
    • Understand the regulatory landscape and how to stay compliant.

This 60-minute webinar is designed for professionals in the pharmaceutical industry looking to enhance their knowledge of GMP environmental controls and HVAC systems to maintain a sterile production environment. Ensure your cleanroom operations meet the highest standards of quality and safety.

Join Now!

Environmental control in pharmaceutical cleanrooms is critical to ensuring the production of high-quality products. Maintaining and monitoring key factors such as airborne particulates, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is essential to prevent contamination.

This course covers:

    • Design, validation, and monitoring of cleanroom HVAC systems.
    • Compliance with international regulatory standards.
    • Best practices for maintaining cleanroom integrity.
    • Testing requirements for a compliant cleanroom environment.

By attending this training, participants will:

    • Gain a comprehensive understanding of cleanroom environments.
    • Learn the latest HVAC strategies to ensure product safety and quality.
    • Understand the regulatory landscape and how to stay compliant.

This 60-minute webinar is designed for professionals in the pharmaceutical industry looking to enhance their knowledge of GMP environmental controls and HVAC systems to maintain a sterile production environment. Ensure your cleanroom operations meet the highest standards of quality and safety.

Join Now!

Why you should attend

Understanding, designing, and validating a cleanroom’s HVAC system is crucial to achieving the environmental control needed to meet regulatory standards for particulate and microorganism levels, ensuring the production of high-quality pharmaceutical products.

This webinar will:

    • Detail US and international regulatory requirements for cleanroom classification.
    • Provide a comprehensive overview of cleanroom HVAC mechanics, including:
      • Engineering diagrams and schematics to illustrate system components.
      • An in-depth look at HVAC equipment components and automated control systems.
      • Key considerations for cleanroom design to ensure optimal efficiency and sanitization.
      • The importance of proper building construction and layout in achieving system efficiency.
    • Explain HEPA filtration principles, including:
      • Achieving desired cleanroom airflow patterns.
      • HEPA filter leak testing procedures.
    • Offer valuable insights on differential pressure, air velocity, flow rates, and air pressure balancing, along with controls and specifications for temperature and relative humidity.
    • Review current air monitoring systems for non-viable particulate and microorganism measurement.
    • Present comprehensive procedures for cleanroom cleaning and sanitization, including:
      • An overview of the best disinfectants available, with their respective advantages and disadvantages.
    • Address cleanroom contamination risks due to personnel, focusing on gowning techniques and aseptic practices.
    • Detail the full set of requirements for HVAC system validation, including:
      • Ongoing monitoring of the cleanroom environment.
      • Handling out-of-spec (OOS) actions as needed.

Enroll Now!

Understanding, designing, and validating a cleanroom’s HVAC system is crucial to achieving the environmental control needed to meet regulatory standards for particulate and microorganism levels, ensuring the production of high-quality pharmaceutical products.

This webinar will:

    • Detail US and international regulatory requirements for cleanroom classification.
    • Provide a comprehensive overview of cleanroom HVAC mechanics, including:
      • Engineering diagrams and schematics to illustrate system components.
      • An in-depth look at HVAC equipment components and automated control systems.
      • Key considerations for cleanroom design to ensure optimal efficiency and sanitization.
      • The importance of proper building construction and layout in achieving system efficiency.
    • Explain HEPA filtration principles, including:
      • Achieving desired cleanroom airflow patterns.
      • HEPA filter leak testing procedures.
    • Offer valuable insights on differential pressure, air velocity, flow rates, and air pressure balancing, along with controls and specifications for temperature and relative humidity.
    • Review current air monitoring systems for non-viable particulate and microorganism measurement.
    • Present comprehensive procedures for cleanroom cleaning and sanitization, including:
      • An overview of the best disinfectants available, with their respective advantages and disadvantages.
    • Address cleanroom contamination risks due to personnel, focusing on gowning techniques and aseptic practices.
    • Detail the full set of requirements for HVAC system validation, including:
      • Ongoing monitoring of the cleanroom environment.
      • Handling out-of-spec (OOS) actions as needed.

Enroll Now!

Areas Covered

    • Regulatory Cleanroom Classification and Requirements
    • GMP Compliance of Cleanroom Environment
    • Cleanroom Design and Layout
    • HVAC System Components
    • HEPA Filtration
    • Differential Pressure and Air Pressure Balancing Considerations
    • Temperature and Humidity Controls
    • Non-Viable Particulate Monitoring Systems
    • Microbial Monitoring Systems
    • Personnel Gowning and Aseptic Practices in Cleanroom
    • Cleaning and Disinfection
    • HVAC System Validation

BONUS:

  1. PDF copy of the presentation handout for your future reference.
  2. Soft copy of the certificate of completion on request.
  3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
    • Regulatory Cleanroom Classification and Requirements
    • GMP Compliance of Cleanroom Environment
    • Cleanroom Design and Layout
    • HVAC System Components
    • HEPA Filtration
    • Differential Pressure and Air Pressure Balancing Considerations
    • Temperature and Humidity Controls
    • Non-Viable Particulate Monitoring Systems
    • Microbial Monitoring Systems
    • Personnel Gowning and Aseptic Practices in Cleanroom
    • Cleaning and Disinfection
    • HVAC System Validation

BONUS:

  1. PDF copy of the presentation handout for your future reference.
  2. Soft copy of the certificate of completion on request.
  3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

Who is this course for

Maximize the Learning Experience in A Group Setting!

    • Quality Assurance Manager
    • Cleanroom Validation Engineer
    • HVAC System Designer
    • Regulatory Affairs Specialist
    • Pharmaceutical Manufacturing Supervisor
    • Environmental Monitoring Technician
    • GMP Compliance Officer
    • Facility Maintenance Manager
    • Cleanroom Operations Manager

Maximize the Learning Experience in A Group Setting!

    • Quality Assurance Manager
    • Cleanroom Validation Engineer
    • HVAC System Designer
    • Regulatory Affairs Specialist
    • Pharmaceutical Manufacturing Supervisor
    • Environmental Monitoring Technician
    • GMP Compliance Officer
    • Facility Maintenance Manager
    • Cleanroom Operations Manager

Instructor Profile

Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years’ experience in pharmaceutical quality assurance and manufacturing. In his career, Mr Cowan has held various manager / director positions in quality assurance, QC laboratory, technical services validation, manufacturing, and clinical supply manufacturing and distribution. He has taught courses in microbiology at Seneca College (pharmaceutical technology program) in Toronto, Canada. His areas of expertise include...

Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years’ experience in pharmaceutical quality assurance and manufacturing. In his career, Mr Cowan has held various manager / director positions in quality assurance, QC laboratory, technical services validation, manufacturing, and clinical supply manufacturing and distribution. He has taught courses in microbiology at Seneca College (pharmaceutical technology program) in Toronto, Canada.

His areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US/international regulatory requirements, regulatory submissions, and quality assurance/control.

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