A key for cleaning validation is that data demonstrates consistency and effectiveness initially and over time. There is an increasing call for the use of statistics for use in cleaning validation programs. Statistics can be appropriately used to evaluate data to determine variability. Statistics are widely used in the pharmaceutical industry including such programs as process validation. From evaluating data in the design of a cleaning process to routine monitoring of a validated cleaning process, statistics conceivably could be used in many situations.

This instructor-led training course will start with a detailed review of statistical principles and practices, including process capability indexes. It will then cover the use (and mis-use) of statistics in pharmaceutical cleaning validation. Practical illustrations will be given including process capability indexes, histograms (bar charts) and line charts to assess the “health” of the data obtained in a facility’s cleaning validation program.

Learning Benefits:

• Understanding fundamentals of statistics.
• Learning the appropriate use and limitations of statistics.
• Seeing how to calculate and use a capability index.
• Modeling the use of histograms and line charts for evaluating data and your program’s “health”.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Reasons why this is a “hot topic”,
Principles and basics of statistics,
Process capability indexes,
Use and mis-use of statistics,

11:30 AM 10 Minute Break

                Modeling process capability indexes for cleaning validation data,
Modeling histograms for cleaning validation data,
Use of histograms for qualification protocol data,
Use of line and bar charts to evaluate ongoing control and consistency,

12:30 PMLive Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

• A copy of the presentation slides
• A certificate of training for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

• Statisticians/Information Technology
• Quality Control, Quality Assurance, Manufacturing Personnel
• Regulatory Affairs Personnel
• Toxicologists/Pharmacologists
• Senior Management responsible for cleaning validation
• Technical Support, Engineering

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.