- Datum:
-
- Webinar
Environmental Monitoring - Trending, Analysis and Data Management - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
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 )
- Plotting recovery rates and excursion rates
- Demonstration of contamination recovery rates per USP
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
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
