Environmental Monitoring: A Contamination Control Tool

Environmental Monitoring:
A Contamination Control Tool

February 9th, 2021
11:00 AM — 12:00 PM EST

The draft revision to EudraLex Annex 1 emphasizes the importance of a well-defined contamination control strategy. Environmental monitoring (EM) is an essential component of a site’s contamination control toolkit. In this webinar, we will discuss what EM does (and doesn’t do), and how to develop or refine an EM program to achieve a well-rounded contamination control strategy. This webinar is ideal for quality assurance, quality control, and manufacturing personnel seeking to understand how EM fits into a contamination control strategy, to learn how to data-mine from an EM program, and to identify improvement opportunities.

Top Five Benefits

  1. Learn the purpose of EM, and the role EM does and does not play in the contamination control
  2. Understand the impact of room cleaning on contamination control
  3. Understand the importance of personnel in a controlled environment, from aseptic behavior to gowning to interventions
  4. Identify potential red flag practices with the aid of real-world examples
  5. Learn how to use your EM program to identify and control sources of contamination
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FDA Discusses Data Integrity – The Challenges & CSA Application

FDA Discusses Data Integrity:
The Challenges & CSA Application

January 26th, 2021
1:00 PM — 2:00 PM EST

There are two parts to this webinar:

  1. Data Integrity Challenges and Avoiding Compliance Issues
  2. Computer Software Assurance (CSA) Application to Data Integrity

Beyond the conversation of ALCOA and ALCOA+, the panelists will discuss data integrity challenges the industry is facing and the importance of controls around application-related data followed by several of the most common FDA non-compliance findings, where the DI guidance may not have covered. Speakers typically tend to talk about the ways that facilities fail to meet regulatory requirements, however, these panelists will talk about ways that the industry may exceed regulatory requirements (i.e., best practices).

The second and hottest topic of this webinar is CSA –

  • “Computer System Validation” (CSV) has remained mostly unchanged for the past two decades. General Principles of Software Validation (GPSV), issued by the FDA in 2002, has been and continues to be the primary tool industry uses as guidance on this topic. CSV, as it stands today, is a documentation heavy exercise Documentation is done at the expense of critical thinking and testing.
  • “Computer Software Assurance” (CSA) is a new way of thinking that emerged from a collaboration between the industry and the FDA’s new “Case for Quality” (CfQ) initiative. CSA brings about a paradigm shift in this approach by encouraging critical-thinking over documentation.

During this webinar you will understand how CSA can be adapted to benefit your organization and be applied to Data Integrity.

Top Ten Benefits

  1. Hear from industry thought leaders on their data integrity experiences
  2. Latest Updates on the FDA CSA draft guidance from FICSA Team
  3. FDA’s tips on how companies can meet regulatory requirements
  4. The intent of the Data Integrity guidance
  5. Establishing and maintaining Data Integrity
  6. Handling perceived Data Integrity challenges
  7. See where applying CSA is acceptable regarding data integrity
  8. How Data Integrity (DI) requirements should be treated
  9. Utilizing opportunities to align regulatorily, enforcement and compliance approaches
  10. Understanding Data Integrity as a business process
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