Environmental Monitoring Training Certificate Program (PDA 102)

OVERVIEW

The Environmental Monitoring (EM) Training Certificate Program is a specialized, competency-based program designed to provide a comprehensive understanding of environmental monitoring practices in pharmaceutical cleanroom environments. Grounded in the principles outlined in PDA Technical Report No. 13, this program equips participants with the knowledge and practical skills necessary to design, implement, and maintain a robust EM program that supports contamination control and regulatory compliance.

Environmental monitoring is a critical component of aseptic processing and sterile product manufacturing. It provides ongoing assurance that cleanroom environments are operating within qualified parameters and that the risk of microbial and particulate contamination is effectively controlled. This training program explores the scientific rationale, regulatory expectations, and operational strategies that underpin a successful EM program.

Participants will learn how to identify appropriate monitoring locations, select and validate sampling methods, interpret EM data, and respond to excursions. The program emphasizes risk-based decision-making, data trending, and integration of EM into the overall contamination control strategy. It also addresses the human factors, equipment design, and procedural controls that influence environmental quality.

The curriculum is aligned with global regulatory requirements, including FDA, EU GMP Annex 1, and ISO 14644, and reflects current industry best practices. Through a combination of lectures, case studies, hands-on demonstrations, and assessments, participants will gain practical insights into the design and execution of EM programs across different cleanroom grades and manufacturing scenarios.

Participants who complete the program and pass the final assessment will receive a Certificate of Completion in Environmental Monitoring.

LEARNING OBJECTIVES

Upon completion of this event, the attendee will be able to:

1. Apply current regulatory guidance to your environmental monitoring program
2. Implement improved environmental monitoring procedures
3. Compare and contrast new and existing environmental monitoring equipment
4. Outline how to best utilize current environmental monitoring definitions
5. Define key environmental monitoring concepts

WHO SHOULD ATTEND

This event is intended for professionals involved in quality assurance, microbiology, manufacturing, validation, and regulatory compliance. It is particularly valuable for those responsible for establishing or maintaining EM programs in sterile manufacturing facilities.

RELATED EVENTS

PDA TRI Environmental Monitoring Events