Environmental Monitoring Fundamentals and 2019 FDA, EMA and Health Canada Key Regulatory Requirements of a Monitoring Program Within a cGMP Facility

Live, Interactive Training Webinar

Date: Tuesday February 5, 2019
Time: 10:30am - 12:30pm ET (New York Time)
Instructor: Barry A. Friedman Ph.D. Biography>>>

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Environmental monitoring of controlled and classified environments and utility systems is required to maintain compliance per EMA/FDA/Health Canada requirements. To perform this task, knowledge of the fundamentals of the systems and their requirements is a must. Doing this requires the ability to identify the "key" elements of the Monitoring Program. Understanding the regulations and the regulatory expectations must be accomplished to assure that all of the necessary SOPs, testing and appropriate specifications are developed, implemented and met. Relying on hearing from others that an activity must be executed in a specific way to "meet industry standards" or "meet industry expectations" leads only to disastrous consequences. Learning what documents form the foundation is required for the knowledge base. The necessary regulatory documents must be in place and translated into the various SOPs. Both non-sterile and sterile production facilities must possess these documents. Significant source documents include ISO 14644, Annex 1 (revised March 2009), FDA’s Aseptic Processing Guidance document (September 2004), USP 1116 (revised May 2012), PDA Technical Report No. 13 (revised 2014), etc.

Regulatory inspection approaches need to be understood and must extend beyond the testing and include reporting and storage. Can your facility readily retrieve two years of data in a readable form within a day of a request during a Regulatory audit? In addition, are all of the "Controlled" and "Classified" areas qualified/validated from an environmental monitoring standpoint to meet the requirements of the API or product that is being manufactured within those areas. And, what is the Regulatory position for a "classified" environment for non-sterile manufacturing?

The objective of this live training webinar is to explore and define the necessary elements required for the development and implementation of an Environmental Monitoring Strategy for a controlled/classified environment. Its further intent is to use the knowledge gained and apply it to the implementation of activities required to assure that your facilities maintains themselves within a state of readiness and have performed the cleaning, disinfection, testing and reporting to meet regulatory requirements. The overall instructor-led training webinar is designed to assist in assuring that your organization is maintaining itself within a GMP compliance framework. "Real life examples", i.e., Form FDA 483s and Warning Letters will be used to illustrate specifics.

Learning Benefits:
-A review of the fundamentals of an Environmental Monitoring program.
-Identifying key elements of an Environmental Monitoring Program.
-A review of the "Controlled" and "Classified" environment.
-Learning what the Regulatory expectations are -- not what others advise needs to be done "to meet industry standards".
-Interpretation of the Regulatory expectations within a cGMP facility.
-Inspection approaches to monitoring a "Controlled" and "Classified" environment.
-Key variables within a "Controlled" and "Classified" environment.
-Assure your understanding of the fundamentals of an Environmental Monitoring Program.
-Be able to identify the key elements of this Program.
-Understand how the regulations impact your cGMP facilities' "Controlled" and "Classified" environment.
-Understanding the various inspection approaches to monitoring a "Controlled" and "Classified" environment.
-Consideration required for the Design and Operation of a "Controlled" and "Classified" environment.
-Evaluating why a documented plan needs to be in place prior to the start of environmental monitoring and how it lends to being able to reduce testing through Risk Assessment.

Webinar outline and time breakdown:

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Fundamentals of an Environmental Monitoring Strategy,
Identifying key elements of an Environmental Monitoring Program,
A review of the Regulatory Expectations,
11:30 AM Break
11:40 AM Interpretation of Regulatory expectations within a CGMP facility,
Inspection approaches to monitoring a "Controlled" and "Classified" environment,
"Real life" examples -- FDA 483s and Warning Letters,
12:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Auditing Professionals
  • Microbiology Professionals
  • Facility Personnel

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Course Number: 225

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