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PDA 102.2 Technical Report No. 13: Fundamentals of an Environmental Monitoring Program

Apr 15 - Apr 16, 2021
8:30 AM
-
4:00 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

Environmental surveillance is a tool utilized to evaluate the effect of controls on the manufacturing environment. A process to assess the cleanroom and other controlled environments of a pharmaceutical facility can serve as an adjunct to the sterility assurance program for the microbial quality of drugs. The items addressed in this online training course include definitions, standards, surveillance support systems, system surveillance, validation systems, definitions and typical frequencies and levels.

This live online training course will review different types of environmental monitoring equipment and media. Participants will be able to determine appropriate sampling sites and methods based on area classification, activities performed and surface type. They will also be able to develop a surface and air environmental monitoring program for PDA's cleanroom.

For more options and/or related training courses, please visit the page(s) below.

PDA Environmental Monitoring Training Courses

Agenda

  • Day 1
  • Day 2
  • Introductions, Objectives and Expectations (30 min)


    Section 1: Introduction to TR13 (60 min)


    Section 2: Definitions and Acronyms (30 min)


    Break (15 min)


    Section 3: EM Classifications and Regulatory Expectations (90 min)


    Break (60 min)


    Section 5a: EM by Application and Rapid Technologies (90 min)


    Discussion/Q&A (45 min)

  • Section 5b: Personnel Monitoring (45 min)


    Section 5c: Monitoring During Sterility Testing (15 min)


    Section 4a: Cleaning, Disinfection and Sanitization (45 min)


    Break (15 min)


    Section 4b: Sample Site Selection - Activity (60 min)


    Section 4c: Sampling Frequency (45 min)


    Break (60 min)


    Section 4d: Levels/Limits, Data Collection and Interpretation - Activity (45 min)


    Section 4e: ID of Organisms and Investigations - Activity (45 min)


    Discussion/Q&A (45 min)

Trainers

Marc G. Glogovsky
Marc G. Glogovsky
Valsource Inc.
Dona B. Reber
Dona B. Reber
Pfizer

Learning Objectives

  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 training course is for professionals who are involved in design and execution of an environmental monitoring program in sterile drug manufacturing.

Departments
  • Quality Control
  • Manufacturing
  • Quality Assurance Operations
  • Validation

Roles
  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager
  • Analyst

Registration Fees

Register Now
Registration Type Price
All Participants $899

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