Seminar on Applied Statistics for FDA Process Validation training seminars presented by Global Compliance Panel register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

** NOTE: All April seminars are live Virtual or Online click to view events.

Seminar on Applied Statistics for FDA Process Validation  

 Email information about this seminar Seminar on Applied Statistics for FDA Process Validation by Global Compliance Panel to yourself your manager or associates Email this event... View and register for other training seminars like Seminar on Applied Statistics for FDA Process Validation by Global Compliance Panel on FindaSeminar.com Find similar training.. Find and register for other training seminars by Global Compliance Panel on FindaSeminar.com Other seminars from Global Compliance Panel

By:

Global Compliance Panel   

For:

Process Scientist/Engineer, Design Engineer, Product Development Engineer, Regulatory/Compliance Professionals, Design Controls Engineers, Six Sigma Green Belt, Six Sigma Black Belt, Continuous Improvement Managers

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process development and validation program consistent with the FDA guidance.  (see full course description)

 

 Seminar / Training class dates & locations

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

FDA+Process+Validation+guidance+documents training seminars workshops conferences online training

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search

NEW  Don't miss training you want to attend

Receive a personal Training Alert when training you want to attend comes to your area. Create a personal Training Alert now  it's Free and only takes a minute!


 

 

 

share this page 

print the agenda print agenda for the Seminar on Applied Statistics for FDA Process Validation seminar

 

 

Training Course Syllabus:


Applied Statistics for FDA Process Validation

Overview:

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.

Why should you attend:

The Food and Drug Administration (FDA) provided a guidance for industry in 2011 that has established a framework for process validation in the pharmaceutical industry. This guidance, titled Process Validation: General Principles and Practices consists of a three-stage process. The three stages are 1) Process Design, 2) Process Qualification, and 3) Continued Process Verification.

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process development and validation program consistent with the FDA guidance. This course teaches the application of statistics for setting specifications, assessing measurement systems (assays), using design of experiments (DOE), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although established for the pharmaceutical industry, it also provides a useful framework for other industries.
Analyses in this course use the point-and-click interface of JMP software by SAS.

Areas Covered in the Session:

• apply statistics to set specifications and validate measurement systems (assays)
• develop appropriate sample plans based on confidence and power
• implement suitable statistical methods into a process validation program for each of the three stages
• Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)
• Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ
• Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

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

Speaker:

Richard (Rick) K. Burdick

Richard (Rick) K. Burdick is an Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc. for 10 years. He taught at ASU for 29 years at all levels including undergraduate business students, MBAs, Master of Statistics students, and doctoral candidates in both business and engineering. He received numerous teaching awards and taught a variety of courses for adult learners. His research and consulting interests consider several CMC statistical applications including comparability studies, stability data analysis, analytical method validation, quality by design process characterization, and analytical similarity for biosimilar products. He has written over 60 journal articles and three books, including Confidence Intervals for Random and Mixed ANOVA Models with Applications to Gauge R&R Studies, (with C. M. Borror and D. C. Montgomery) and Confidence Intervals on Variance Components, (with F. A. Graybill). Burdick is a Fellow of the American Statistical Association and a member of the American Society for Quality. He has served on the USP Statistics Expert Committee since 2010. He received his Bachelors Degree in Statistics from the University of Wyoming. He received his Masters and Doctorate degrees in Statistics from Texas A&M University.

Seminar Summary:

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process development and validation program consistent with the FDA guidance.  (see full course description)

print this agenda print agenda for the Seminar on Applied Statistics for FDA Process Validation training seminar

 view dates and locations for this seminar

 

 

 

Custom Search