Mitigating Risk Factors in the Development and Implementation of an Environmental Monitoring Strategy for Controlled/Classified Environments - Meeting FDA and Global Regulatory Requirements

Environmental monitoring of controlled and classified environments and their systems is required to maintain compliance with 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, appropriate specifications and testing are developed, implemented and met. Relying on obtaining from others that a procedure 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 August 2023), FDA’s Aseptic Processing Guidance document (September 2004), USP 1116 (revised May 2012), 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 that area? And, what is the Regulatory position for a "classified" environment for non-sterile manufacturing?

The objective of this live, interactive training session 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, qualification and reporting to meet regulatory requirements. This 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. Please plan to attend with a cross-function group to gain the most from this interactive webinar.

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 suggest needs to be done "to meet industry standards"
• Interpretation of the Regulatory expectations within a cGMP facility
• Understand 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

Who Should Attend

The following individuals or disciplines will benefit from attending this webinar:

• Quality Assurance Personnel
• Quality Control Personnel
• Validation
• Project Management
• Manufacturing