PDA 612.1 Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines

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This live eLearning training course offers a deep dive into the analysis required for Environmental Monitoring (EM) with specific consideration to cGMP and Data Integrity guidelines. As such, the training course is two-fold. The first portion focuses on primarily data analysis for EM. This is for both routine data analysis as well as the analysis required for excursions and investigations with respect to process risks and industry requirements/guidelines. The second portion deals with assessing and maintaining compliance to data integrity guidelines. These two seemingly independent subjects are tied together when we consider that data integrity best practices are required for compliant and meaningful data analysis. Data analysis performed for EM must be risk based, including assessment of data integrity. Furthermore, data integrity tools - such as accurately tracing actions through audit trails - can be crucial to investigations, an area cited by regulators.

Upon completion of this training course, the attendee will be able to:

  1. Conduct detailed EM data analysis for both routine, state of control monitoring, including frequency, filtering data, grouping data and selection of the meaningful analysis types (e.g. tabular, regression, control chart etc.)
  2. Conduct detailed EM data analysis as well as non-routine data analysis for excursions and investigation with an understanding of the regulatory expectations
  3. Explain the inherent risks in EM data management and their counter measures
  4. Define an overview of the general data integrity guidelines from all organizations and identify possible causes of a breach. Demonstrate true understanding of Quality Culture with respect to its effects on data integrity
  5. Demonstrate the ALCOA+ principles including the reason behind each principle and its applicability in routine operations and root cause analysis

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