Two Day Applied Statistics for FDA Process Validation Course - Chicago, IL, United States - February 16th-17th, 2017 - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Applied Statistics for FDA Process Validation" conference to their offering.

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, "...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle:

Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

Who Should Attend:

- Process Scientist/Engineer

- Design Engineer

- Product Development Engineer

- Regulatory/Compliance Professional

- Design Controls Engineer

- Six Sigma Green Belt

- Six Sigma Black Belt

- Continuous Improvement Manager

Agenda:

Day 1 Schedule

Lecture 1: Introduction to Statistics for Process Validation

- Principles of process validation

- Stages of process validation

- Primer on Statistical Analysis

- Basic statistics

Lecture 2: Primer on Statistical Analysis (cont.)

- Statistical intervals and hypothesis testing

Lecture 3: Primer on Statistical Analysis (cont.)

- Statistical intervals and hypothesis testing

- ANOVA

Lecture 4: Primer on Statistical Analysis (cont.)

- Regression

- Run charts

Day 2 Schedule

Lecture 1: Foundational Requirements for Process Validation

- Setting specifications

- Analytical methodology

- Stage 1 - Process Design

- Steps to DOE

- Screening designs

Lecture 2: Stage 1 - Process Design

- Response surface designs

- Establishing a strategy for process qualification

Lecture 3: Stage 2 - Process Qualification

- Introduction

- Incorporation of large-scale data

- Development of PPQ acceptance criteria

- Development of sampling plans

Lecture 4: Stage 3 - Continued Process Verification

- Statistical process control

- Process capability

For more information about this conference visit http://www.researchandmarkets.com/research/htmqpc/applied

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Pharmaceutical Manufacturing

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Pharmaceutical Manufacturing