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Date: 18th March, 2010

Location: On-Line, North America

Summary:
Pharmaceutical - Web Seminar

Click here to Register for this Seminar

Environmental monitoring of controlled and classified environments is required to maintain compliance per FDA/EU requirements. When a new or remodeled controlled and/or classified manufacturing area is established, a plan is required to determine the manufacturing surface and airborne testing (ISO 14644). This testing may extend to the media, personnel, incubators, refrigerators, development of SOPs, etc.

The program will involve the 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 determine the earliest possible date for initiation of production. Any equipment that is required to initiate monitoring along with their IQ, OQ, PQ and their SOPs need to be in place. The same is required for incubators and refrigerators that must be temperature mapped to include the setting up of alarms and 'offsets'.

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 version32/33), etc.

The objective of this live and interactive BenAstrum web training course is to explore and define the necessary elements in the development of an Environmental Plan for a controlled/classified environment, and assist in assuring that your organization is maintaining itself within a GMP compliance framework.

Discussion Points:

• Describing the regulatory requirements related to an environmental monitoring program
  


• Identifying key elements of an environmental monitoring program
  


• Determination of critical sampling locations, appropriate sampling methodologies and frequencies
  


• Determining appropriate Alert and Action Levels for different ISO classifications
  


• Determining an appropriate method of data trending
  


• Identifying criteria and procedures for initiating Non-Conformance Investigations
  

Developing an Environmental Plan for a Controlled/Classified Environment - Webinar