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

Dec 01, 2020
1:30 PM
-
4:30 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online
Register Now

Overview

This 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 interdependent subjects are tied together when we consider that data integrity best practices are required for complaint 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.

Trainers

Sheba Zaman
Sheba Zaman
Novatek International
Bio
Sheba Zaman
Novatek International

Sheba Zaman has been serving in a technical role at Novatek International for over 18 years. With university degrees in both Health Science and Computer Science, she is an expert in the data management and analysis of critical pharmaceutical computer systems such as Environmental Monitoring, Utility Monitoring, Cleaning Validation, LIMS, Stability and Quality Management Systems. Currently Head of Product Specialists and Training Services, she is experienced in helping companies manage and analyze their analytical data. She has worked with clients globally for over a decade managing change and implementation of software solutions, including establishing procedures, work instructions, validation scripts and training programs. Key areas of expertise include Data Integrity, Process Improvement, FDA compliance and Software Implementation and Optimization in a regulated environment. She also serves as a President-Elect for the PDA Southern California Chapter.

Learning Objectives

  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

Who Should Attend

This training course is intended for professionals who are involved in viable and non-viable environmental monitoring, particularly for those investigating or performing data analysis, including supervision of such analysis.

Departments
  • Quality Control
  • Quality Systems
  • Quality Compliance
  • Engineering
  • Manufacturing
  • Quality Assurance Operations

Roles
  • Operator/Technician
  • Supervisor
  • Manager
  • Scientist
  • Auditor/Inspector
  • Microbiologist

Registration Fees

Register Now
Registration Type Price
Member $300
Non-member $300
Gov't/Health Auth./Academic $300

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