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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Early Bird Pricing
Register before 19 October 2024
Early Bird Member Price
$2,699GovernmentMember Only
$2,099
Health AuthorityMember Only
$2,099
AcademicMember Only
$2,099
Non-Member
$3,239
Standard Pricing
Register after 19 October 2024
Standard Member Price
$2,999GovernmentMember Only
$2,099
Health AuthorityMember Only
$2,099
AcademicMember Only
$2,099
Non-Member
$3,599
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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James Wamsley
ValSource, Inc.
Read Bio
James Wamsley
ValSource, Inc.
James Wamsley has nearly 20 years experience in aseptic and low-bioburden operations, quality, training, contamination control and environmental monitoring. He spent more than 11 years at PDA's Training and Research Institute responsible for management and delivery of laboratory training courses. He has since spent time in roles with progressively more responsibility including aseptic performance improvement for clinical drug product manufacturing, development lead for contamination control and EM program at a new high-throughput SVP manufacturing facility, and as site lead for contamination control and environmental monitoring at clinical/commercial vaccine and gene therapy drug substance and drug product site.
James earned his Bachelor of Science in Biological Sciences from the University of Maryland, Baltimore County and is currently a Microbiology Consultant for ValSource, Inc.
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Open Biopharma Research and Training Institute
1958 Kellogg AvenueCarlsbad, CA 92008, USA
Accommodations
The following hotels are located near the training course location:
Courtyard by Marriott
5835 Owens Ave
Carlsbad, CA 92008
Hampton Inn Carlsbad-North San Diego County
2229 Palomar
Airport Rd
Carlsbad, CA 92011
Homewood Suites by Hilton Carlsbad-North San Diego County
2223 Palomar Airport Rd
Carlsbad, CA 92011
Fairfield Inn & Suites by Marriott San Diego Carlsbad
1929
Palomar Oaks Way
Carlsbad, CA 92011