Applied Statistics for FDA Process Validation 2018

Description:

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.

The first stage of process validation is process design. The Process Validation guidance document states, "A successful validation program depends on information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of a manufacturing process that results in products with desired quality attributes:

 

Why you should 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.

 

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)

Who Will Benefit:

  • 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

Speaker:

Heath Rushing

Co-founder and Principal, Adsurgo

Heath Rushing is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. Previously, he was the JMP and Six Sigma training manager at SAS. He led a team of nine technical professionals designing and delivering applied statistics and quality continuing education courses. He created tailored courses, applications, and long-term training plans in quality and statistics across a variety of industries to include biotech, pharmaceutical, medical device, and chemical processing. Mr. Rushing has been an invited speaker on applicability of statistics for national and international conferences.

 

Location:  Philadelphia, PA Date: December 6th & 7th, 2018 and Time: 9:00 AM to 6:00 PM

Venue: DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153

 

Price:

Until October 20, Early Bird Price: $2,000.00 Price: $2,000.00 (Seminar Fee for One Delegate)

From November 21 to December 05, Regular Price: $2,200.00

Register for 5 attendees Price: $10,000.00

Register for 10 attendees Price: $20,000.00

Register now and save $200. (Early Bird)

 

Sponsorship Program benefits for seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

 

 

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

 

Registration Link -  https://www.globalcompliancepanel.com/seminar/applied-statistics-for-FDA-process-validation-901927SEMINAR?seo

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7 Views

06 Dec 2018 - 07 Dec 2018

Event Serial
: ECA10529
Event Type
: Seminar
Contact Person
: Event Manager Send Message
Deadline for abstracts/proposals
: 04 Dec 2018
Organized by
: Netzealous LLC DBA - Globalcompliancepanel
Venue
: Philadelphia, PA, United States of America

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