PDA 102.3 Technical Report No. 13: Fundamentals of an Environmental Monitoring Program
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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.
Upon completion of this training course, the attendee will be able to:
- Apply current regulatory guidance to your environmental monitoring program
- Implement improved environmental monitoring procedures
- Compare and contrast new and existing environmental monitoring equipment
- Outline how to best utilize current environmental monitoring definitions
- Define key environmental monitoring concepts
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Member Price
$2,199GovernmentMember Only
$1,539
Health AuthorityMember Only
$1,539
AcademicMember Only
$1,539
Non-Member
$2,639
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].
Featured Trainers
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Marc Glogovsky, MS
Business Unit Manager - Microbiology, ValSource, Inc.
Read BioMarc Glogovsky, MS
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 25 years and is presently serving on the Board of Directors and on the planning committee for the PDA/FDA Joint Regulatory Conference. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and served on the Education, Science and ATMP Advisory Boards. In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA's Training and Research Institute, the 2022 Michael Korczynski Award for his support of PDA's international activities and a Service Appreciation Award in 2023 for his time spent as the Microbiology/EM Interest Group Leader. Marc earned his BS in Biology from Monmouth University and his MS in Microbiology & Molecular Genetics from Rutgers University.
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4350 East West Highway, Suite 110Bethesda, MD 20814, USA
ACCOMMODATIONS
The following hotels are located near the training course location:
Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD
20814