Simple Linear Regression in Recovery Studies

WEBINAR

Course description

This course focuses on one of the most significant and at the same time overlooked aspects of cleaning validation: recovery. During the course we shall discuss about the main design aspects of a recovery study by following a practical approach.

A case study will be presented including a recovery study with the participation of three analysts, of different experience level in recovery studies. We will present a methodology based on the simple linear regression model and we will show how it can be applied to create a simple linear model per analyst. In addition, we shall demonstrate how the analysts can be assessed in terms of their qualification for participating in sampling. Finally, we will demonstrate how the attendees can utilize the template in order to estimate residues on equipment at the end of cleaning operations.

The methodology will be demonstrated in python, a free development software via a template with step by step instructions for the user. Instructions shall be provided to the users not familiar with python and the template will be made available to attendees at the end of the course. We will demonstrate how the attendees can import their results in a “ready-to-use” python template in order to create a simple linear model which shall describe the recovery results.

Note that the methodology that will be presented can be used by practicioners in any type of statistical software (Excel, Minitab, R).

Course outline

• The basics of designing and setting in place a recovery study
• A real case study including “real-life” sampling results for three Analysts
•  Introduction to the basics of simple linear regression
• Explaining the metrics which shall provide the recovery method and analyst qualification
• Demonstration of the simple linear regression methodology for the case study
• Comparison and assessment of Analysts
• Converting real sampling results from equipment at the end of cleaning operations into residues based on the simple linear regression model
• Discussion, Q&A

Learning Objectives

• Recovery studies: basics, methodology
• Analyst Qualification for sampling activities via Recovery studies
• Connection between recovery and sampling as part of cleaning validation planning
• Assessment of residues on equipment at the end of cleaning operations
• Basics of Simple Linear Regression

Who should attend

• Quality Assurance teams/ employees who manage cleaning validation and supervise cross contamination activities,
• Quality Control teams/ employees who design and/or participate in recovery studies as well as supervise and/or perform sampling of equipment at the end of cleaning operations,
• Validation teams/ employees who design, manage, run and/ or supervise cleaning validation activities,
• Production Supervisors/ Team members who supervise and/ or perform cleaning and/or sampling operations and/or train personnel in cleaning and/or sampling operations,
• Any roles/ employees involved in the overall management of cross contamination activities in Pharmaceutical, Biotechnology, APIs Manufacturing Facilities.

This course has been designed for entry-level as well as experienced professionals in cleaning validation and recovery.

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