GlobalCompliancePanel Seminar “Applied Statistics for FDA Process Validation” successfully done in Philadelphia, PA at May 17th & 18th, 2018.

GlobalCompliancePanel have been successfully organized the 2 days seminar in Philadelphia, PA from May 17th & 18th, 2018 by NetZealous LLC.

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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 Seminar 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.

The seminars organized In Guidance for Industry Process Validation: General Principle and Practices and On the First day of the seminars which was 17th of May 2018, GlobalCompliancePanel had covered Introduction to Statistics for Process Validation, Primer on Statistical Analysis (cont.) with Mr. Heath Rushing is cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery.

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On the second day of the GlobalCompliancePanel Seminar which was 18th of May 2018, was covered Foundational Requirements for Process Validation, Stage 1 – Process Design, Stage 2 – Process Qualification and Stage 3 – Continued Process Verification with Mr. Heath Rushing is cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery.

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The use of Applied Statistics for FDA Process Validation

Why you Should be Worried about HIPAAThe use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA prescribes a three-stage process that any organization in the pharmaceutical industry has to set up:

  1. Process Design
  2. Process Qualification
  • Continued Process Verification.

The Process Design stage, which is called Stage 1, is when the organization defines the commercial manufacturing process. The knowledge that the organization has gained through development and scale-up activities serves as the basis for the development of this definition.

The Process Qualification, or Stage 2, involves evaluating the process design for the purpose of determining if the process defined in Stage I has the capability for reproducible commercial manufacturing.

The next stage of the FDA process validation stage is to determine if the Process Design stage and the Process Qualification stage give the ongoing assurance that the process remains in a state of control during routine production. This is what Stage 3, the Continued Process Verification, does.

Thorough understanding of how to implement Applied Statistics for FDA Process Validation

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The ways of using Applied Statistics for FDA Process Validation will be the topic of a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing. At this seminar, Richard Burdick, Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc., will be the Director.

Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901132SEMINAR?wordpress-SEO to register for this meaningful and highly valuable seminar on applied statistics for process validation. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A methodical approach to implementing statistical methodologies

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The focus of this two-day course on Applied Statistics for FDA Process Validation is the various ways by which a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance can be established.

Dr. Burdick will begin with a primer on statistics, where he will explain how the methods of Applied Statistics for FDA Process Validation seminar can be applied in each remaining chapter.

The two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays), will be taken up next.

The next aspect of applied statistics Dr. Burdick will move on to is how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Since the methods taught through all these three stages are recommended by regulatory guidance documents; this seminar on Applied Statistics for FDA Process Validation will provide references to the specific citations in the guidance documents.

The aim of this learning on Applied Statistics for FDA Process Validation is to lead participants into ways of establishing a systematic approach to implementing statistical methodologies into a process development and validation program that is consistent with the FDA guidance.

Complete learning on Applied Statistics for FDA Process Validation

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Over the two days of this seminar, the participants will learn how to:

  • Apply statistics for setting specifications
  • Assess measurement systems (assays)
  • Use Design of Experiments (DOE)
  • Develop a control plan as part of a risk management strategy, and
  • Ensure process control/capability.

All concepts at this Applied Statistics for FDA Process Validation seminar are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although aimed at the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation provides a useful framework for other related industries, as well.

In this important learning on Applied Statistics for FDA Process Validation; Dr. Burdick will cover the following areas:

  • 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.

keep enhancing FDA Process Validation

FDA guidance on process validation

FDA guidance on process validation

The FDA guidance on process validation is an important document that offers guidelines on Process Validation (PV), a critical aspect of medical device and pharmaceutical manufacturing.

In November ’08, the FDA issued a draft guideline that revised the old guidelines on PV. The FDA guidance on process validation was now the standard that replaced the FDA guidance on process validation that was in force from 1987.  FDA guidance on process validation underwent another revision in January 2011, which is now the current standard. It has altered the spirit of the earlier documents in a few ways.

January 2011 changes

  • It now gives greater emphasis to use ICH Q 8, 9 and 10;
  • The term ‘commercial manufacturing’ has come to replace the old word, ‘commercial production’. This means a significant change in the scope of the ICH.
  • The January 2011 FDA guidance on process validation has also given a slightly different definition of PV and Stage 1 and Stage 2.
  • The new FDA guidance on process validationdescribes PV as “The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”

Why did the FDA change guidelines on PV?

The FDA guidance on process validation underwent changes because it was observed during its investigations that drugs of inferior quality were being marketed even though they were manufactured under less demanding processes, which were being passed off as “validated”.

Manufacturers need to ask these:

In essence, FDA guidance on process validation requires manufacturers to ask themselves these questions:

  • Which scientific evidence I have used gives me the confidence that my process is capable of consistently and repeatedly delivering quality product?
  • Can I show that my process works as intended?
  • What are the ways by which I can know that my process has remained in control?

References:

http://www.gmp-compliance.org/eca_news_2380_6764,6864,6917,6971.html

http://www.gmp-compliance.org/eca_news_2600.html

 

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