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PDA 102.1 Technical Report No. 13: Fundamentals of an Environmental Monitoring Program

Oct 07, 2021
Washington, DC

  • Education
  • The Americas

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Overview

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 training course include regulations, current methodologies, equipment, identification, disinfection and cleaning, monitoring frequency and alert/action levels.

This 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

Agenda

  • Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

Marc G. Glogovsky
Marc G. Glogovsky
Valsource Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    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
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in 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.

Grand Hyatt Washington

1000 H St NW
Washington, DC

  • Accommodations

    The PDA room block is not currently open. Please check back June 2021.

  • Amenities

    More information coming soon.

How to Get Here

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Directions

Registration Fees

Early Registration
Registration Type Price By August 23, 2021
Member $899
Non-member $1,079
Gov't/Health Auth./Academic* $699
Regular Registration
Registration Type Price After August 23, 2021
Member $999
Non-member $1,199
Gov't/Health Auth./Academic* $699

* 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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Tel: +1 (301) 656-5900
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