GMP Environmental Monitoring Training Overview

Attend this GMP Environmental Monitoring Pharmaceutical webinar to various US and international regulatory requirements, the testing requirements for the various clean room classifications as well as the environmental monitoring of clean room environments. It will describe the Action and Alert Levels and how these levels are determined for a particular facility along with Corrective and Preventative Actions are defined.

Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room.

As the FDA Guideline on Aseptic Processing GMP (2004) states:

“In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.”

Therefore, ongoing environmental monitoring of a clean room environment is necessary to assure the quality and safety of the pharmaceutical product.

Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.  

Why Should You Attend

As per FDA Guideline on Aseptic Processing GMP (2004) one of the most important laboratory controls is the environmental monitoring program which provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.

Hence a proper understanding and testing of the clean room environment and ongoing environmental monitoring of a clean room environment is necessary from a product compliance perspective.

We will discuss all current air & surface monitoring systems for the measurement of non-viable particulate, microbial contaminants in the clean room . The subject of clean room contamination due to personnel is discussed including both gowning technique and aseptic practices. Then Ongoing monitoring practices for the clean room environment are discussed with respect to sampling frequency, sampling locations, and the investigation of action level excursions. This is followed by a discussion of how environmental monitoring data is reviewed (Data Trend Reports) for product release.


Why Should You Attend

This webinar first explains the various US and international regulatory requirements for the various clean room classifications as well as the environmental monitoring of clean room environments.

Next, the presentation details the benefits, the regulatory requirements and the testing requirements for a comprehensive Environmental Monitoring Program.

A description of Action and Alert Levels follows along with a discussion of how these levels are determined for a particular facility. Corrective and Preventative Actions are defined.

All current air monitoring systems for the measurement of non-viable particulate are fully reviewed.

All current air and surface monitoring systems for the measurement of microbial contaminants in the clean room are discussed in detail.

The subject of clean room contamination due to personnel is discussed. This includes both gowning technique and aseptic practices.

Ongoing monitoring practices for the clean room environment are discussed with respect to sampling frequency, sampling locations, and the investigation of action level excursions.

This is followed by a discussion of how environmental monitoring data is reviewed for product release.

Finally, a comprehensive look is taken of the current thinking about the generation and review of Environmental Monitoring Data Trend Reports.


Webinar Takeaway

This webinar will provide valuable assistance to all personnel in:

•     GMP Compliance of Clean Room Environment

•     Regulatory Clean Room Classification and Requirements

•     Environmental Monitoring Program

•     Action and Alert Levels

•     Non-Viable Particulate Monitoring Systems

•     Microbial Monitoring Systems

•     Personnel Gowning and Aseptic Practices in Clean Room

•     Clean Room Monitoring Practices - Frequency, Locations, and Investigations

•     Product Release

•     Environmental Monitoring Data Trend reports

Who will Benefit from GMP Environmental Monitoring Course

•     Quality Assurance

•     Environmental Monitoring

•     Microbiology

•     Manufacturing

•     Validation

•     Engineering

•     Maintenance 

Choose a Purchase Options

$249

Live Webinar - Single Participant 60-mins

You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$1,095

Live Group Up to 10 Participants

You get 10 log-in for the live 60-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email

$299

Recorded Access Single Participant 60-mins

You'll have 12 month single user access to log-in for an archived recording of the entire 60-minute webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$499

Recorded Access Corporate Group 60-mins

You'll have 12 month group access to log-in for an archived recording of the entire 60-minute webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

 FDA Faculty Roger Cowan

Faculty Roger Cowan

Pharmaceutical Consultant at R Cowan Consulting Services LLC

Arlington, Texas, United States

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 37 years experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada.   

Our Participants Testimonial


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Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

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The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

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