Process Development and Validation rest on the right Design of Experiments and Statistical Process Control

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The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies.

The Quality Unit needs to take a practical orientation when it sets out doing this work. An approach in which case studies and examples are sprinkled goes a long way in helping Process Validation professionals in their work. This is exactly what a seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will offer and help regulatory professionals in the Quality Control and Quality Assurance areas achieve their aims.

The Director of this two-day seminar is Dr. Steven Kuwahara, who Founder and Principal, GXP BioTechnology LLC. Want to understand ways by which to adapt the right approach to applying DoE and SPC to the development, design and monitoring of manufacturing and testing? Then, please register for this very useful session by logging on to Process Development and Validation rest on the right Design of Experiments and Statistical Process Control . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Completely interactive

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Dr. Kuwahara will do full justice to the role and importance of practical experiments in aiding an understanding of Design of Experiments. Theoretical information will be given only when it is needed to help gain an understanding of an experiment. At this highly interactive and practical session, Dr. Kuwahara will offer examples from real processes and testing procedures. He will intersperse these with examples that will be directly applicable to the areas of work that relate to the participants of this seminar.

An understanding of the way the process parameters relate to and work with each other is necessary for any pharmaceutical worker who is involved in performing, supervising or reviewing manufacturing or testing processes. The ability to monitor the performance of processes and test methods is also needed for such a worker. While this is true for a professional in any department of pharmaceuticals; it applies more to the worker who works in Quality Control and Quality Assurance, a requirement that has become necessary following the passage of recent FDA guidance document on Process Validation.

However, it is the development, manufacturing, or quality systems worker who carries out this work. In view of this fact, a high degree of coordination is needed between these two levels of employees. At this seminar, Dr. Kuwahara will arm these two levels of employees with the knowledge of the ways of designing the systems and studies, and then interpreting the results generated.

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Dr. Kuwahara has charted out the following agenda for this seminar:

Dietary Design of Experiments

  • Introduction
  • One Level, One Factor Designs. Simple Comparisons
  • Two-Level Multi-Factorial Design
  • Extracting Information from the Experiment

Statistical Process Control

Design of Experiments and Statistical Process Control

This seminar is designed for the benefit of professionals involved in the procedures and applications of DOE and SPC, such as Directors, Managers, Supervisors, Lead workers in Process Development, Manufacturing, Regulatory Affairs, Quality Assurance and Quality Control, and workers who participate in operations or the are involved in the supervision of the development, manufacturing, or testing of medicinal products.

To join us for more information, get in touch

Validation the complies with ICH guidelines

A clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures, and acceptance criteria in calibration limits is required from professionals in the field of statistical analysis. They also need to have a proper understanding of process and quality controls, as well as ICH Q8 and Q9.

The guideline the ICH has set out for analytical methods validation is the ICH tripartite-harmonized ICH Guideline on Text, which was previously coded as Q2A, finalized in October 1994 under Step 4. This guideline seeks to identify the validation parameters that are required for a number of analytical methods. The characteristics and parameters that need to be taken into consideration when validating the analytical procedures that are included in the registration applications are also laid down in this guideline.

When it comes to procedures and acceptance criteria in calibration limits, the ICH guideline is the ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B. This was finalized in November 1996 under Step 4. This guideline extends the ICH guideline on Text, or what is called Q2A (mentioned above) to comprise the actual experimental data required, along with the statistical interpretation, for the validation of a variety of analytical procedures.

Current Step 4 for process and Quality Control

The current guideline for process and Quality Control is the Current Step 4 version of the ICH-harmonized Tripartite Guideline. The final draft of this guideline has been recommended for adoption to the regulatory bodies of the three biggest pharmaceutical markets in the world, namely the US, the EU and Japan.

Meeting critical milestones is required for professionals who want to achieve harmonization in Quality, professionals. Conducting stability studies, the way the studies define relevant limits for the testing of impurities, and following a more malleable approach to pharmaceutical quality that is based on the principles of Good Manufacturing Practice (GMP) risk management are among these milestones. ICH’s Quality guidelines on harmonization relating to Quality cover the following areas:

o  Stability

o  Analytical Validation

o  Impurities

o  Pharmacopoeias

o  Quality of Biotechnological Products

o  Specifications

o  Good Manufacturing Practice

o  Pharmaceutical Development

o  Quality Risk Management

o  Pharmaceutical Quality System

o  Development and Manufacture of Drug Substances

o  Lifecycle Management.

A thorough training session on the areas of Validation in accordance with ICH guidelines

It is important and necessary for professionals in this area to get proper guidance, considering the complexity and the breadth of the issues associated with these techniques, which cover both the pharmaceutical and clinical applications, and considering that these techniques apply to a number of area such as stability testing, outlier analysis and risk management.

A seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will offer this learning. Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama, will be the Director of this seminar. Please visit Validation the complies with ICH guidelinesto register for this valuable learning session. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A clear and deep understanding of statistical concepts

Dr. Bartolucci will offer in-depth and clear learning of the statistical concepts used for investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and Quality Control, as well as with ICH Q8 and Q9.

Although not a course in statistics, this seminar will offer an applied approach to the statistical techniques used and will show how to reasonably interpret them. Participants can use this learning to address the various challenges facing pharmaceutical and biotechnology companies when they have to quantify results in a meaningful interpretable manner through tabulations and graphical presentations.

Another area of importance at this seminar is the expectations of different regulatory agencies regarding the quantification and development of a sound statistical monitoring of a properly utilized, effective, and efficient process control. It will familiarize the participants with the critical aspects of the statistical methods and explain to them the practical application of these guidelines.