This 90-minute webinar will discuss various broad and critical aspects of an effective EM program such as the Phases of a cleanroom EM Program–Pre-Monitoring of a Cleanroom prior to Facility Validation, Facility Validation, Implementation of Routine EM using Facility Validation data and Post-validation. Procedural Steps, Content of a robust EM program such as handling, incubation, setting alert and action limits, Documentation, Management and Trending of Data, EM Excursion investigation, and Product Impact and Disposition will be discussed.
Upon completion of this training, you will be able to:
- Describe how Cleanroom Environmental Monitoring (EM) Program fits into the Regulations
- Explain the basis of the Four (4) Phases of Cleanroom transitional monitoring (Pre-qualification through post-qualification EM) and what each type stands for
- List the basic content of a well-designed, effective and compliant EM Program
- How to set alert and action limits and Explain the relationship between an EM Excursion Program and CAPA
Who will benefit:
This webinar will provide a great resource to product manufacturers with personnel in the Pharmaceutical, Biotechnology, Biologics, Drugs, Diagnostics, Cell Therapy, and Medical Device Industries.
- Quality Control,
- Quality Assurance
- Microbiologist, Facilities
- Chemist, Analysts
- Sterility Assurance
- Testing Technicians
- Environmental Testing Personnel
- Raw Materials Manufacturers
- Clinical, Research and Development
Course Outline: Agenda
- Applicable Regulations – Where does the EM Program fit in the Regulation? – Role of Cleanroom Environmental Monitoring Program?
- Basics of Setting a Robust and Effective EM Program – Key Considerations – Relevant Material Verification Processes – Steps and Content of an EM Program Testing Procedure
- Processing a Completed Environmental Monitoring Test Media – Sample Handling and Incubation – Documentation and Data Management of EM Test Results – What is the EM Test Data used for? – Retention of EM Test Results – Interpretation of EM Test Results
- Basics of Designing an Effective and Compliant EM Trend Reports – Types; Content – Using Trend Report as a Critical Tool and Quality Metrics
- Basics of Designing an Effective and Compliant EM Excursion Program – Types; Content – Handling EM Excursion Investigation – Handling Impacted Manufactured Batches – Disposition of Affected Products with Failed Cleanroom EM Test Results
- Corrective and Preventative Action (CAPA) – Relationship between CAPA and EM Test Data Excursion Investigations Question and Answer Session