Online Safety Community

“Understanding the practical application of statistics?”

The application of statistical methods is specified all through 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries for these activities:

o  Setting validation criteria and specifications

o  Performing Measurement Systems Analysis (MSA)

o  Conducting stability analysis

o  Using Design of Experiment (DOE) for process development and validation

o  Developing process control charts

o  Determining process capability indices.

The Quality System Regulation (QSR) for medical devices states that manufacturers should take steps, where appropriate, for establishing and maintaining procedures with which to identify valid statistical techniques needed to establish, control, and verify that the process capability and product characteristics are acceptable.

Methods are specified in 21 CFR and guidance documents

Both 21 CFR and guidance documents emphasize the need for statistical methods from discovery through product discontinuation. While 21 CFR specifies the suitable statistical procedures needed to establish both in-process and final specifications; the guidance documents require applying statistical methods for development and validation of measurement systems, process understanding using Quality by Design (QbD) principles, process validation, as well as ensuring that the manufacturing process is in a state of control and is capable.

Even though many statistical methods may be applied to fulfil this part of the QSR; there exist a few commonly accepted methods that all companies can and preferably should use for: 

o  Developing acceptance criteria

o  Ensuring accurate and precise measurement systems

o  Fully characterizing manufacturing processes

o  Monitoring and controlling process results, and

o  Selecting an appropriate number of samples.

Learn the dynamics of statistical methods

The nitty gritty of application of statistical methods will be the teaching a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be offering. At this seminar, Heath Rushing, who is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP; will be the Director.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. To understand the areas of implementation of statistical methods that comply with the requirements set out in CFR 21 and guidance documents, please enroll for this session by visiting "Understanding the practical application of statistics"

A full description of statistical processes

This course provides instruction on the statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries. The Director will explain the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building need to be applied. Upon establishment of competence in each of these areas; he will present the way these need to be applied in an industry-specific manner.

During the course of these two days, Heath will cover the following areas:

·        Describe and analyze the distribution of data

·        Develop summary statistics

·        Generate and analyze statistical intervals and hypothesis tests to make data-driven decisions

·        Describe the relationship between and among two or more factors or responses

·        Understand issues related to sampling and calculate appropriate sample sizes

·        Use statistical intervals to setting specifications/develop acceptance criteria

·        Use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility

·        Ensure your process is in (statistical) control and capable.

Views: 109

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Martin walker is now a member of Online Safety Community
3 hours ago
Nakul Pratap posted a blog post

How to become an expert Safety Consultants

If you want safety culture at your workplace, you should have certified safety consultantA Safety consultant is the person who gives advices and aides the employees with respect to health and safety of both small and large size such as manufacturing factories, engineering, construction, mining and so on  Likewise the safety consultant guides you to rectify the solution for issues by enhancing the health and safety standards, policies as well as by limiting injuries and mishaps at work…See More
7 hours ago
Adam Fleming posted a blog post

What do Your Customers Really Think About Your Complaint Handling?

Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Complaint Handling” on February 6. Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar.Please visit http://bit.ly/2GFGiXr to enroll for this webinar.—————————————————————————————————————A complaint says a lot about a product. It helps the manufacturer to reflect on where it…See More
8 hours ago
kate smith posted events
Wednesday

Forum

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade 13 hours ago.

Important of Warning sign 1 Reply

Warning sign is a type of traffic sign that guide a hazard ahead on the road. Having proper warning sign on the road provide a healthy environment.Continue

Tags: Signs, Workplace, Safety, Sign, Warning

Started by healthandsafetysigns. Last reply by Jen McDade Jan 14.

Workers paticipation in safety management 2 Replies

Workers paticipation in safety management is the aspect which is required to be implemented in the OHSAS 18001 2007 version. , I invite our experience community members to share their views on the…Continue

Tags: management, safety, in, paticipation, Workers

Started by SafetyRaja. Last reply by Tara safe Dec 27, 2018.

How to improve safety culture of factories 4 Replies

How to improve safety culture of factories having mostly contract and casual ever changing workers for whom training and monitoring both are major issues. Such qorkers are mainly meeting accidents in…Continue

Started by Harkant Dave. Last reply by Jen McDade Dec 24, 2018.

[General Industry] What is your workplace's policy on headphones? Working on one currently. 1 Reply

I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their…Continue

Tags: general, industry, distraction, music, phone

Started by Kyle C. Johnson. Last reply by Jen McDade Dec 19, 2018.

Badge

Loading…

© 2019   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service