Live Online Training - Handling OOT Results

Live Online Training - Handling OOT Results

Course No 18329

All times mentioned are CEST

Costs

ECA-Member: EUR 890,--
Non ECA Member: EUR 990,--
EU/GMP Inspectorates: EUR 495,--
APIC Member Discount: EUR 950,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Christopher Burgess, Burgess Analytical Consultancy, UK

Objectives

This new online Training Course participants will get practical advice on how to identify OOT Results. You will get to know how to use the statistical tool box for detecting OOT data. During the training the following aspects will be discussed:
  •  Regulatory concern for the control of processes
  •  Data types and distributions
  •  Variations and statistical control
  •  Statistical tool box
  •  Process stability versus process capability
  •  Recommendations for process control of variables and attributes
Participants will get a worksheet document and a preparation document for pre-reading upfront. During the training feedback related to the worksheet is requested which will be discussed by the speaker. Possible solutions will be suggested and recommendations will be provided.

Background

Laboratory tests are performed on active pharmaceutical ingredients, excipients and other components, inprocess materials, and finished drug product. In these tests a trend can occur and a trend analysis has to be performed by applying techniques for detecting an underlying pattern of behaviour in a time or batch sequence which would otherwise be partly or nearly completely hidden by noise.

There are two distinct types of trend situations:
  •  No trend is expected, for example for production or analytical process data which are known or assumed to be under statistical control.
  •  A trend is expected, for example in stability testing.
There is a fundamental difference between these two situations in that the variance increases with time in the second Situation.

Trend analysis is of regulatory relevance and a key aspect in both in EU guidelines (e.g. Annex 15, EU GMP-Guide) and FDA Guidances (e.g. Guidance for Industry, Process Validation: General Principles and Practices).

The ECA Working Group on Analytical Quality Control decided to address these aspects and developed a harmonised guideline SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results. It encourages the application of  a consistent and scientifically sound approach to trend analysis as part of a QMS. The current Version 2 is available for all ECA members on the ECA members area.

Target Group

This training is recommended for all levels of technical staff and managerial personnel dealing with out-of-trend results, including analytical laboratories, contract laboratories, and Quality Assurance/Quality Control personnel.

Programme

09.00 – 09.15 h Introduction

09.15 – 09.45 h 
Regulatory Importance of Trend Analysis
  •  Expectations
  •  Process capability and performance
  •  Regulatory references
  •  Future requirements
09.45 – 10.30 h 
An Introduction to the Statistical Tool Box; Distribution of Data and its Characterisation
  •  Specifications and processes
  •  Data types and models
  •  Populations and samples
  •  Data distributions
  •  Errors and confidence intervals
10.30 – 10.45 h 
Questions & Answers

10.45 – 11.00 h Break

11.00 – 12.00 h 
Trending for Process Control of Variables
  •  Statistical Process Control
  •  Individual and moving range charts
  •  Process capability indices
  •  CUSUM & EWMA charts
  •  Investigation using CUSUM
12.00 – 12.15 h 
Questions & Answers

12.15 – 13.15 h  Break

13.15 – 13.55 h 
Workshop 1 on Variables
SPC of continuous individual and grouped monitoring data using the moving range and mean and range methods
  •  Interpretation
  •  Conclusions
13.55 – 14.15 h 
Feedback from Workshop 1
 
14.15 – 15.15 h 
Trending for Process Control of Attributes
  •  Basic differences between attributes and variables
  •  Distributional requirements
  •  AQLs & sampling for attributes [OOE attributes with a batch]
  •  Control charts for attributes; an overview
15.15 – 15.30 h 
Questions & Answers

15.30 – 15.45 h Break

15.45 – 16.25 h 
Workshop 2 on Attributes
ATP bioluminescence is used to provide a rapid and simple method to monitor the microbiological cleanliness of a process plant at a Critical Control Point (CCP). The data, in the form of discrete Relative Light Units (RLU), measure the amount of microbial ATP.
  •  Interpretation
  •  Conclusions
16.25 – 16.45 h 
Feedback from Workshop 2
 
16.45 – 17.00 h 
Overall Questions & Answers Session

17.00 h End of training

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