Developing an Environmental Monitoring Strategy for a Non-Sterile and Aseptic Processing Area | October 5, 2015 8:30 AM - October 6, 2015 4:00 PM | Automation.com

Developing an Environmental Monitoring Strategy for a Non-Sterile and Aseptic Processing Area

Event Summary

DATE:
October 5, 2015 - October 6, 2015
LOCATION:
San Francisco, CA 94108
COUNTRY:
USA
START DATE/TIME:
October 5, 2015 8:30 AM
END DATE/TIME:
October 6, 2015 4:00 PM
EVENT TYPE:
Training
HOST:
ComplianceOnline
PHONE:
888-717-2436
EMAIL:
[email protected]
WEBSITE:
Click here to Visit

Description

Course Description:
Environmental monitoring of non-sterile and aseptic processing areas (controlled/classified environments) and utility systems is required to maintain compliance per EU/FDA/Health Canada requirements. When a new or remodeled controlled and/or classified manufacturing area is established, a validation plan is needed to determine manufacturing surfaces, airborne testing (ISO 14644) and the utility monitoring that is required. This testing may extend to the media, personnel, incubators, refrigerators, development of SOPs, etc. The program will involve the DQ, IQ, OQ and PQ of the site and all of its equipment. Since the facility’s environmental and utility plan must be established and in compliance prior to the initiation of manufacturing, an extensive Gantt chart is a prerequisite to assure all activities are completed in a predetermined order and that the earliest possible date for initiation of production may be met.

The necessary regulatory documents also need to be in place and translated into the various SOPs. Significant source documents include ISO 14644, Annex 1 (revised March 2009), FDA’s Aseptic Processing Guidance document, USP (current version), and USP<1111> (for non-sterile products), etc.

The highly interactive two day seminar will explore and define the necessary elements in the development and implementation of an environmental monitoring strategy for a non-sterile and an aseptic processing area to include utility systems (controlled and controlled/classified environment). It will assist in assuring that your organization is maintaining itself within a cGMP compliance framework. Case studies that include Warning Letters will be discussed to illustrate regulatory environmental issues.



Learning Objectives:
Upon completing this course on developing environmental monitoring strategy participants will:

Assure their understanding of the fundamentals of an environmental monitoring program
Be able to identify the key elements
Understand how the regulations impact their cGMP non-sterile or aseptic processing areas and their "Controlled" and "Classified" environment
Understanding the various inspection approaches to monitoring a "Controlled" and "Classified" environment
Learn how to determine the regulatory requirements required for an environmental monitoring program
Be able to develop and initiate the use of a purified water, WFI and steam system
Recognize the issues of their water system before the system is commissioned
Learn how to use Failure Mode Effects Analyses to determine the critical sampling locations, appropriate sampling methodologies and frequencies for both environmental and utility systems
Be able to develop DQ/IQ/OQ/PQ requirements
Learn how to determine appropriate Alert and Action Levels for different ISO and water classifications
Understand the movement from a “paper” method of data trending


Who will Benefit:
Quality professionals
Regulatory professionals
Compliance professionals
Manufacturing engineers
Quality engineers
Quality auditors
Quality Control
Microbiology
Document control specialists



For Registration - http://www.complianceonline.com/environmental-monitoring-strategy-for-a-non-sterile-and-aseptic-processing-area-hvac-and-utility-systems-seminar-training-80216SEM-prdsm?channel=automation


Note: Use coupon code 232082 and get 10% off on registration.

MORE EVENTS

  • Avnet IoT Workshop on How to start your next IoT project

    Getting the right start when you’re implementing IoT in your business is critical. Our IoT readiness workshop is designed by industry experts who...

  • Green Datacenter Conference

    Green Datacenter Conference will feature all new talks, and interactive sessions designed to help you implement secure, efficient data center...

  • PLM Certificate Program

    For 35 years, CIMdata has been working in the Product Lifecycle Management (PLM) industry. Our consulting services and research expertise are known...

  • Tire Technology Expo 2019

    Tire Technology Expo is Europe's most important tire manufacturing technology exhibition and conference. Exhibits cover the complete spectrum of...

  • Industry of Things World USA

    The Industry of Things World team invites you to connect with over 500 Industrial Internet experts on Mar 07-08, 2019 at the Marriott Marquis San...

VIEW ALL

RELATED