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 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
- 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
- The three-way Chart
- Examples of three-way charts
Trending Tool Applications
- Trending tool examples from industries
- Data collection Tools
- Investigation and risk assessment for negative Trends
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®)
Interactive Case Studies
Workshop
- In this workshop, 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
- 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
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