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.