The Relationship of Designing an Effective Environmental Monitoring Program and Determining a Cleanroom State of Control

Charity Ogunsanya

Starting at

$279

Premier price: $251 (save 10%)

Single registration

Buy Now
This course will discuss the various steps associated with the EM program from the Phases, through Validation, Implementation, Procedural Steps, Documentation Practices, Data Management, Trending of Data, EM Excursion and the relationship of the cleanroom state of control and product impact and analysis.

Why Should You Attend:

The importance of designing an effective Environmental Monitoring program cannot be overemphasized. The data from this program provides an effective measuring tool that determines an effective cleanroom controls from a Facility design, validation, implementation, disinfection, disinfectant effectiveness, gowning controls, cleanroom trafficking, aseptic controls, personnel training and practices. This webinar will you understand the requirements of an effective Environmental Monitoring (EM) program - a key determining factor of a cleanroom state of control that helps product manufacturers in preventing an inadvertent loss of product from contamination during the production process or to rule out a product contamination arising from the cleanroom facility during an investigation if an effective program is designed.

It also serves as a critical program that supports and guides other contamination control key evaluators and other production and testing processes that helps in ruling out cleanroom contamination using the data generated. This webinar will help the attendee understand the requirements of an effective Environmental Monitoring (EM) program - a key determining factor of a cleanroom state of control that helps product manufacturers in preventing an inadvertent loss of product from contamination during the production process or to rule out a product contamination arising from the cleanroom facility during an investigation if an effective program is designed. This important course will discuss various broad aspects including the relationship of the effective design of an EM program and its relationship with the Production and Process Controls per 21 CFR Parts 211.113 “Control of Microbiological Contamination” and 21 CFR Subpart G Section 820.70.

Learning Objectives:

This webinar will enhance the attendee skills in the following areas:

  1. The applicable regulations guiding the environmental monitoring program, its association with contamination control and a state of cleanroom controls.
  2. The four (4) phases of the Environmental Monitoring (EM) program, types of media used for the program and how to choose the different types of media per frequency of testing.
  3. Choosing an effective and compliant Environmental Monitoring sampling plans, sampling sites, alert and action levels, testing procedures, testing types as well as how to handle a completed EM test media plates.
  4. Process and relate the adequacy of an effective Environmental Monitoring excursion investigation to a continued cleanroom contamination and state of control.
  5. Evaluate and write an effective Environmental Monitoring trend report to using the data effectively from the testing program.

Areas Covered in the Webinar:

Complying with the requirements of Below are specific topics and sub-topics that will be discussed:

  1. Regulations Guiding the Environmental Monitoring Program
    • Contamination and Control Process (Production and Process Controls)
    • 21 CFR Part 211.113 “Control of Microbiological Contamination”
    • 21 CFR Subpart G Section 820.70.
  2. 4 Phases of the Environmental Monitoring (EM) Program:
    • What constitutes Phase I of an Environmental Monitoring Program
    • What constitutes Phase II of an Environmental Monitoring Program
    • What constitutes Phase III of an Environmental Monitoring Program
    • What constitutes Phase IV of an Environmental Monitoring Program
  3. The Importance of an Environmental Monitoring Program and Cleanroom State of Control
  4. The Importance of an Environmental Monitoring Program and a Contamination Control Program
  5. Environmental Monitoring Program Test Media
    • Types of Media Used for Program
  6. Minimizing Cleanroon Contamination
    • Trafficking within a Classified Area
  7. Environmental Monitoring Program Testing or Sampling Procedure
    • Dynamic Monitoring or Testing Procedure
    • Static Monitoring or Testing Procedure
  8. Environmental Monitoring Sampling Plans
    • Details of Performing an Environmental Monitoring Sampling Plans
    • Content of an Environmental Monitoring Sampling Plan
  9. Environmental Monitoring Sample Site Selection
    • Guidelines for Routine Sampling Sites Selection
    • Minimum Routine Environmental Monitoring FrequenciesSample Types Designation
  10. Alert and Action Levels
    • Setting Alert Levels
    • Setting Action Levels
  11. Training as a Key Criteria
    • Quality Control Personnel Training
  12. Types of Sampling
    • Types of Environmental Sampling
    • Types of Personnel Sampling
    • Other Types of Sampling
  13. Processing a Completed Environmental Monitoring Test Media
    • Incubating Viable EM Samples
    • Documentation and Retention of Environmental Monitoring Results
    • Interpretation of an Environmental Monitoring Results
  14. Evaluation of Environmental Monitoring Excursion Trend Data
    • Writing an Environmental Monitoring Trend Reports
    • Summary of how to Draft an Effective Trend Report
    • Content of an Environmental Monitoring Trend Report
    • What to do with an Environmental Monitoring Trend Report
  15. Processing an Effective Environmental Monitoring Excursion Investigation
    • Types of Environmental Monitoring Excursions
      • Non-viable Particulate Excursions
      • Temperature and Relative Humidity Excursions
      • Air Pressure Differentials Excursions
      • Environmental Excursion Report
    • How to draft an effective Environmental Monitoring Excursion Investigation
    • Content of an Environmental Monitoring Excursion Investigation
    • What to do with an Environmental Monitoring Excursion Investigation
    • Link between an Environmental Excursion Investigation and Product Impact
    • Performing an Effective Microbial Identifications
  16. Corrective and Preventative Action (CAPA)
    • The Link between CAPA and EM Excursion Investigation

Who Will Benefit:

This webinar will provide a great resource to product manufacturers with personnel in the Pharmaceutical, Biotechnology, Biologics, Drugs, Diagnostics, Cell Therapy, Medical Device, In-vitro Diagnostics industries within the following functions:

  • Quality Control, Quality Assurance, Microbiologist, Facilities, Chemist, Analysts, Manufacturing, Validation, Facilities, Materials Management, Engineering, Vendors/Suppliers, Regulatory Affairs and all levels of management.

However, if you are already familiar with this subject, you may recommend this webinar to other professionals that may require additional knowledge about this subject.

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Premier price: $ 539 (save 10%)

Recorded video

Recorded video session

Premier price: $ 314 (save 10%)


Speaker: Charity Ogunsanya, CEO and Founder, Pharmabiodevice Consulting LLC

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.