HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.

Recorded Version Only

(PPT + Recorded Streaming Link)

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Apr-2020

CD or USB Drive Only

(PPT + Recorded Training File)

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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Why Should You Attend:

It is important that a cleanroom’s HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product. This webinar will:

  • Detail and explain the various US and international regulatory requirements for cleanroom classifications.
  • Provide a comprehensive overview of the mechanics of cleanroom HVAC including engineering diagrams and schematics, and:
    • HVAC equipment components will be detailed as well as the automated control systems that are available.
    • Cleanroom design considerations will be discussed.
    • How proper building construction and layout is necessary to achieve both optimum efficiency of the system and optimum cleaning and sanitization of the cleanroom.
  • Describe the principles of HEPA filtration along with:
    • Desired cleanroom airflow patterns and how to achieve them.
    • Proper procedures for HEPA filter leak testing.
  • Provide valuable information on differential pressure, air velocity, flow rates, and air pressure balancing. Temperature and relative humidity controls and specifications will also be detailed.
  • Review all current air monitoring systems for non-viable particulate and microorganism measurement.
  • Present comprehensive procedures for cleaning and sanitization of the cleanroom environment along with a review of the best disinfectants currently available along with their respective advantages and disadvantages.
  • Discuss the subject of cleanroom contamination due to personnel including both gowning technique and aseptic practices.
  • Detail a full set of requirements for HVAC system validation. Ongoing monitoring of the cleanroom environment will be discussed with respect to schedule, specifications and OOS (out-of-spec) actions that may be required.
Areas Covered in the Webinar:
  • GMP Compliance of Cleanroom Environment
  • Regulatory Cleanroom Classification and Requirements
  • HVAC System Components
  • Cleanroom Design and Layout
  • HEPA Filtration
  • Differential Pressure and Air Pressure Balancing Considerations
  • Temperature and Humidity Controls
  • Cleaning and Disinfection
  • Non-Viable Particulate Monitoring Systems
  • Microbial Monitoring Systems
  • Personnel Gowning and Aseptic Practices in Cleanroom
  • HVAC System Validation
Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering
  • Maintenance
Instructor Profile:
Roger Cowan Roger Cowan

Pharmaceutical Consultant, R Cowan Consulting Services LLC

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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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