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PDA 102 Technical Report No. 13: Fundamentals of an Environmental Monitoring Program

Nov 15 - Nov 16, 2021
Bethesda, MD

  • Education
  • The Americas

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Overview

Please note that this training course will take place in person and has hands-on lab activities. Please read our COVID-19 Facility Access Rules before registering for this training course.

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 equipment and media and develop a surface and air environmental monitoring 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.

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

PDA Environmental Monitoring Training Courses

Agenda

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

Trainers

Marc G. Glogovsky
Marc G. Glogovsky
Valsource Inc.
Dona B. Reber
Dona B. Reber
Pfizer

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

    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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By October 1, 2021
Member $2,249
Non-member $2,699
Gov't/Health Auth./Academic* $1,749
Regular Registration
Registration Type Price After October 1, 2021
Member $2,499
Non-member $2,999
Gov't/Health Auth./Academic* $1,749

* 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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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Contact

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Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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