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PDA 102.4 Technical Report No. 13: Fundamentals of an Environmental Monitoring Program

Nov 15 - Nov 16, 2022
11:30 AM
-
2:30 PM
| Singapore Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

Environmental Monitoring is a tool utilized to evaluate the effectiveness of the contamination control strategy in the aseptic and surrounding manufacturing environment. Equipment and tools to assess the clean room and other controlled environments of a pharmaceutical facility serves, in parallel, to the sterility assurance program for the microbial quality of drug products and drug substances. The ideology addressed in this live eLearning training course include regulations, current methodologies, equipment, identification, disinfection and cleaning, monitoring frequency and alert/action levels.

This live eLearning training course will include interactive discussion on current methods, best practices, and rapid methods. It will focus on utilizing monitoring to identify gaps in the contamination control strategy in order to improve the quality of the aseptic environment, support investigations and satisfy the global regulatory expectations from a risk-based viewpoint.

Participants will also receive a free copy of PDA Technical Report No. 13: Fundamentals of an Environmental Monitoring Program.

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

PDA Environmental Monitoring Training Courses

Agenda

  • Day 1
  • Day 2
  • Welcome, Introductions & Objectives (10 min)


    Basics of Microbiology (20 min)


    Introduction to Risk Assessments for Environmental Monitoring (20 min)


    ISO Classifications & Importance of Cleanrooms (30 min)


    Regulatory Documentation (10 min)


    Break (10 min)


    Cleaning & Disinfection; Material Transfer (30 min)


    Sampling Methodologies & Equipment; Introduction to Rapid Microbiological Methods (RMMs) (50 min)

  • Water Systems – Sampling & Monitoring (20 min)


    Sample Site Selection and Frequency (20 min)


    Personnel Monitoring (20 min)


    Media Selection, Incubation & Analytical Methods (30 min)


    Break (10 min)


    Identification of Microorganisms (20 min)


    Data Management (10 min)


    Establishing Alert Levels & Understanding Action Limits (15 min)


    Trending of EM Results (15 min)


    Conducting EM Investigations (20 min)

Trainers

Marc Glogovsky
Marc Glogovsky
Valsource, Inc.

Learning Objectives

  1. Apply current regulatory guidance to your environmental monitoring program
  2. Implement improved environmental monitoring procedures utilizing current methodologies and innovations
  3. Identify, select and apply appropriate monitoring methods to support your monitoring program
  4. Utilize trending to establish appropriate alert limits in your monitoring program
  5. Utilize identification data to support the contamination control strategy and aid in appropriate CAPAs for microbiology deviations/investigations

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

Registration Fees

Register Now
Registration Type Price
All Participants $599

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