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

Nov 16 - Nov 17, 2020
8:30 AM
-
4:00 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online
Closed

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 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

Trainers

Marc G. Glogovsky
Marc G. Glogovsky
Valsource LLC
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

Closed
Registration Type
Member $2,799
Non-member $3,359
Gov't/Health Auth./Academic* $1,959


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