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PDA 102.3 Technical Report No. 13: Fundamentals of an Environmental Monitoring Program

Dec 12 - Dec 14, 2023
Carlsbad, CA

  • Education
  • The Americas
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Overview

Please note that this training course has hands-on lab activities. Please wear long pants and closed-toe shoes.

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 training course include definitions, standards, surveillance support systems, system surveillance, validation systems, definitions and typical frequencies and levels.

During this training course, you will have the opportunity to work hands-on with environmental monitoring (EM) equipment and media and develop a surface and air EM program for PDA's cleanroom. You will utilize the information presented in the lectures to determine appropriate sampling sites and methods based on area classification, activities performed and surface type.

Additional topics that will be discussed:

  • Risk assessments to support EM program
  • Rapid micro method implementation for EM applications
  • EMPQ creation and execution
  • Routine room re-certification as per draft Annex 1
  • Grade A air supply

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

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast will not be provided, but lunch will be provided.

Trainers

Marc Glogovsky
Marc Glogovsky
ValSource, Inc.
Bio
Marc Glogovsky
ValSource, Inc.

Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 25 years in the pharmaceutical industry, in various microbiology and management roles. In his current position, Marc focuses on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs.

He has been an active PDA member for over 20 years and is presently serving on the Board of Directors, both the Science and ATMP Advisory Boards and is the co-chair of the Microbiology/EM Interest Group. Marc is also co-chairing the Microbial Data Deviation Investigations conference and participating on the planning committee for PDA/FDA and Global Microbiology conferences. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and is currently supporting multiple PDA global chapters.

In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA’s Training and Research Institute, and the 2023 Michael Korczynski Award for his work with PDA’s international chapters.

Marc earned his BS in Biology from Monmouth University and his MS in Microbiology & Molecular Genetics from Rutgers University.

Additional Information

  • Learning Objectives

    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 the 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

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Open Biopharma Research and Training Institute

1958 Kellogg Avenue
Carlsbad, CA

How to Get Here

By Air

The nearest airport to the training course location is the San Diego International Airport (SAN).

By Car

There is a parking lot available at the training course location.

Other Options

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Registration Fees

Early Registration
Registration Type Price By October 28, 2023
Member $2,699
Non-member $3,239
Gov't/Health Auth./Academic $2,099
Regular Registration
Registration Type Price After October 28, 2023
Member $2,999
Non-member $3,599
Gov't/Health Auth./Academic $2,099

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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