Dr. Raphael Bar
BR Consulting
Referent:innen
Michael Schiffer
CSL Behring
All times mentioned are CET.
Zielsetzung
This Live Online Training will 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 the 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
- 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.
A prior knowledge of control charts is an Advantage.
A prior knowledge of control charts is an Advantage.
Hintergrund
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 (Draft 2020/2021), results from monitoring should be considered when reviewing batch documentation for finished product release. Therefore, this course is aimed at providing empirical tools for charting and trending EM data.
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 (Draft 2020/2021), results from monitoring should be considered when reviewing batch documentation for finished product release. Therefore, this course is aimed at providing empirical tools for charting and trending EM data.
Zielgruppe
- Environmental Monitoring personnel in facilities of pharmaceuticals, biopharmaceuticals and medical devices
- Microbiologists
- Quality Assurance / Regulatory Affairs personnel
- Production Managers / QC Managers
- Senior Management
Date & Technical Requirements
Tuesday, 12 November 2024, 09.00 – 18.00 h CET
Wednesday, 13 November 2024, 09.00 – 17.00 h CET
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a Standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Wednesday, 13 November 2024, 09.00 – 17.00 h CET
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a Standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Environmental Monitoring: Introduction, Regulations and Practical Aspects
- Overview of current regulations, Draft EU Annex 1
- Practical aspects of environmental Monitoring
- How to set up a structured EM program to gain strong data and handle big data amounts
- Industry best practices
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 of Control Charts of Attributes (Microbial Counts)
- Poisson Distribution
- c Chart
- u Chart
- I-MR versus c Chart
Contamination Recovery Rates
- Contamination recovery rates (USP approach <1116>)
- Plotting recovery rates and excursion rates
- Demonstration of contamination recovery rates per USP <1116>
Overview of Control Charts of Individual Microbial Counts
- Moving range (mR)
- Control charts of individual data (XmR)
- Calculation of control limits
Trending Tool Applications
- Trending tool examples from industries
- Data collection Tools
- Investigation and risk assessment for negative trends
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
- The three-way Chart
- Examples of three-way charts
Demonstration of Building Control Charts of Real-Life Microbial Counts in Classified Rooms (with StatGraphics®)
Interactive Case Studies
In this case study, Michael Schiffer will deepen and discuss in detail the contents of previous lectures using practical examples.
In this case study, Michael Schiffer will deepen and discuss in detail the contents of previous lectures using practical examples.
How to Minimize False Alarms in Environmental Monitoring Data
Part1: Adjusting SPC rules to pharmaceutical process data
Part1: Adjusting SPC rules to pharmaceutical process data
- Why traditional SPC rules are rarely met for microbial data
- State of Control versus State of Statistical Control
- Practical SPC rules
Part 2: Detecting variation and trends in control Charts
- 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
Data Management and Digitalization by Novatek International
- Digitalization of Environmental Monitoring Processes
- Global EM
- Risk Based Environmental Monitoring
- Addressing EU cGMP / Annex 1 /data integrity requirements
- Smart Trending and Reporting using AI
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
Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Übersicht nach Thema..
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Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager"
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E-Mail: info@concept-heidelberg.de
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