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PDA 853.1 Environmental Monitoring

Dec 01 - Dec 02, 2020
1:00 PM
-
4:00 PM
| AUS 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.

Trainers

Marc G. Glogovsky
Marc G. Glogovsky
Valsource LLC

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 intended for professionals who are involved in the design and execution of an environmental monitoring program in sterile drug manufacturing.

Departments
  • Quality Control
  • Quality Systems
  • Quality Compliance
  • Manufacturing
  • Quality Assurance Operations
  • Technical Operations
  • Validation

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

Registration Fees

Register Now
Registration Type Price
Member $200
Non-member $200
Gov't/Health Auth./Academic $200

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