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

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.

Charity Ogunsanya
Director of Quality Control, Pharmabiodevice Consulting LLC

Charity Ogunsanya has over 26 years of extensive experience within the Pharmaceutical, Biotechnology, Biologics, Cell-Therapy, Diagnostics, Research and Development, Radio-pharmaceutical, Contract Manufacturing Organization (CMO) and Medical Device companies.

Throughout her corporate career within these diverse industries, she held various high visibility and business critical roles within the Quality and Compliance division in major Fortune 100 companies both as a Subject Matter Expert (SME), Site Manager, Multi-site Manager and Director Levels receptively. She has been a sought after expert and have been consistently hired after several competitive efforts by major fortune 100 companies 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 difficult regulatory bodies inspectional findings which is always achieved with a successful outcome. She has also been a sought after expert by various companies requesting her expertise as a known industry expert to specifically assume roles in order to perform a total overhaul, restructure, compliance remediation, re-organization, start-up processes related to Quality Systems improvements and/or enhancements. In all cases, her remediation work resulted in several successful National and International regulatory bodies’ inspections, re-inspection and new product approvals.

Her technical expertise are not limited to the 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.

Ms. Ogunsanya is vast in 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. Her expertise has been sought after by several Fortune 100 Pharmaceutical, Biotechnology, Biologics and Medical Device companies as a Quality and Compliance SME during critical national and international regulatory bodies’ routine and new product approval inspections.

She is the CEO of Pharmabiodevice Consulting LLC (www.pharmabiodeviceconsultant.com) targeted towards Quality and Compliance related remediation, enhancements and consultant services for various companies within the industry. She is a well sought after high level consultant for several international professional expert networks such as Gerson Lehrman Group, Zintro Expert Network and Intota Expert Network. She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network.

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