Environmental Monitoring - Trending, Analysis and Data Management - Live Online

Environmental Monitoring - Trending, Analysis and Data Management - Live Online

Course No 18542

This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager". Learn more.

All times mentioned are CET.

Costs

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Raphael  Bar, BR Consulting
Sinéad Cowman, Lonza
Michael Schiffer, CSL Behring

Objectives

This Live Online Training will first present the basic methodology of evaluating the Environmental Monitoring (EM)data using elementary Statistical Process Control (SPC)tools as well as empirical approaches to set microbial control limits for clean rooms. This course will address  he following issues:
  • Overview of controlled rooms classifications, elements of an EM program and present EU and FDA regulations including the recent ISO 14664 changes.
  • How to organize and present an abundant amount of microbial data in meaningful Graphs
  • How to draw useful Control Charts with this data, using the software program Minitab® 19
  • To understand how action and alert control limits are set
  • How to demonstrate that the environmental microbial monitoring process is under a state of control
  • How to calculate and plot the newly proposed Contamination Recovery Rates in USP Chapter <1116>
  • To detect a trend in the environmental microbial monitoring process
  • How to apply risk assessment in investigations
All above issues will be demonstrated on examples and case studies of microbial counts generated in controlled rooms of manufacturing facilities of sterile products.

Background

Regulatory agencies require from manufacturing companies of pharmaceuticals and biopharmaceuticals, particularly of sterile drug products, to maintain an environmental monitoring program, whereby particulates as well as microorganisms in either air samples (active and passive sampling) or in surfaces (contact plates) are routinely tested and monitored.

Thus, a multitude of environmental microbial data is generated on a routine basis and it is recorded in a manner permitting trend evaluation. But collecting EM data is only the first challenge. The following challenge for the responsible person in quality is charting, analyzing data, setting action and alert limits, interpreting the overall monitoring process behaviour, detecting a trend or shift in contamination levels, monitoring excursion rates and contamination recovery rates, while conducting an ongoing risk analysis. According to the recent revision of EU Annex 1 (Dec. 2017), results from monitoring should be considered when reviewing batch documentation for finished product 1638 release. Therefore, this course is aimed at providing empirical tools for charting and trending EM data.

Target Group

  • Environmental Monitoring personnel in facilities of pharmaceuticals, biopharmaceuticals and medical devices
  • Microbiologists
  • Quality Assurance / Regulatory Affairs personnel
  • Production Managers / QC Managers
  • Senior Management

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Environmental Monitoring: Introduction and Regulations
  • Overview of current regulations
  • Draft Annex 1
Variability of Data
  • Standard deviation of a sample and of Population
  • Histogram
  • Standard deviations of the mean range
  • Relation between standard deviation and range
  • Short-term variation versus global Variation
  • Separating the signal from noise
Overview Control Charts of Grouped Data
  • Plotting Run chart and control chart (Process Behavior Chart)
  • Computation of three-sigma control Limits
  • Control charts of average, range and standard deviation
Contamination Recovery Rates
  • Contamination recovery rates (USP approach <1116>)
  • Plotting recovery rates and excursion rates
  • Limits of rates versus actual values
  • Calculations of contamination recovery rates per USP <1116>
Control Charts of Individual Microbial Counts
  • Moving range (mR)
  • Control charts of individual data (XmR)
  • Calculation of control limits
  • The three-way Chart
    • Examples of three-way charts
Trending Tool Applications
  • Trending tool examples from industries
  •  Data collection tools
  •  Reaction and measures on negative trends
  •  Responsibilities
Overview of Control Charts of Attributes (Microbial Counts)
  • Poisson Distribution
  • c Chart
  • u Chart
  • I-MR versus c Chart
Demonstration of Building Control Charts of Real-Life Microbial counts in Classified Rooms (with StatGraphics®)
 
Investigation and Risk Assessment
  • Practical aspects of Environmental Monitoring
  • How to set up an structured EM program and gain strong data
  • Risk-based Approach
  • Handling of big data amounts
  • EM program examples from Industrial clean rooms
How to Minimize False Alarms in Environmental Monitoring Data
  • Why we need to minimize false alarms
  • Why traditional SPC rules are rarely met for microbial data
  • State of control versus state of statistical control
  • Practical SPC rules
  • Examples: Control charts of real-life EM data
Data Strategies and Environmental Monitoring – MODA System
  • Data requirements for the evaluation and selection of an electronic System
  • How to maximise the value of your data
  • Trend analysis tools and tips
  • Setting alert and action Limits
  • Data integrity issues
Strategy for Monitoring a State of Control under Ongoing Process Verification Plan
  • Phase 1 and Phase 2 in process Monitoring
  • Is your EM process under a state of control?
  • Trending and continued process verification
  • Real-time continuous LIF  monitoring of  viable and inert particles

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