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

Jul 23, 2020
Raleigh, NC

  • Education
  • The Americas

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.

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

PDA Environmental Monitoring Training Course Series
PDA Annual Training Course Series

Agenda

  • An agenda will be available soon. 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 LLC

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
    Manufacturing, Quality Assurance, Quality Control, Validation

    Roles
    Analyst, Manager, Specialist, Supervisor, Technician

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Travel

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Raleigh Convention Center

500 South Salisbury Street
Raleigh, NC

How to Get Here

By Air

The closest airport to the training course location is the Raleigh-Durham International Airport (RDU).

By Car

Parking is available at prevailing rates in parking lots and decks surrounding the Raleigh Convention Center. Parking in the Loading Dock or inside the center (except for loading or unloading) is strictly prohibited and violators will be towed at owner’s expense. Please click here for parking maps and additional details.

Other Options

N/A

Directions

Registration Fees

Regular Price
Registration Type Price
Member $999
Non-member $999
Gov't/Health Auth./Academic* $999



* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Jun 23, 2020, no fee will be charged. After Jun 23, 2020, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Jun 23, 2020, a full refund will be given minus a $200 fee. After Jun 23, 2020, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Contact

Program Inquiries
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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