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

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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

  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

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Standard Pricing

Standard Member Price

$599

GovernmentMember Only

$599

Health AuthorityMember Only

$599

Early Career ProfessionalMember Only

$599

StudentMember Only

$599

AcademicMember Only

$599

Non-Member

$599

See Qualifying Criteria for Member Types.

Day 1

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)

Day 2

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)

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