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

Unravelling the DHF, Technical File and Design Dossier

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Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD.

The Design History File

The history of the Design History File is an interesting one. It evolved out of the FDA’s realization, over time and experience; that the major part of a device’s problems was happening during the design stage and change phases, regardless of whether it was a new product or a changed one. This led to the birth of the concept of Design Control, aimed at tracking, monitoring and correcting the design elements at every stage from start to finish.

 

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Outstanding characteristics of the Design History File

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What should the Design History File contain?

The DHF should contain the following:

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Now, the Technical File and Design Dossier

In short and simple terms, one can understand the Technical File and the Design Dossier as the EU’s version of the Design Control and the DHF. In other words, what Design Control and Design History File are for the FDA; the Technical File and Medical Device (MDD) are for the Medical Device Directive.

What should the TF and DD contain?

These files should have all the basic sections needed to support the requirements of the Medical Device Directive (MDD), Essential Requirements (for that product), and the company’s “Declaration of Conformity” for that product:

  • General Information/Product Description/EC Authorized Representative
  • Classification Determination
  • Essential Requirements
  • Risk Analysis
  • Labeling
  • Product Specifications
  • Design Control
  • Clinical Evaluation
  • System Test Reports
  • Functional Bench Testing
  • Lab Testing
  • Sterilization validation (or AAMI TIR 28 Analysis)
  • Packaging Qualifications
  • Manufacturing
  • Sterilization
  • Conclusion
  • Declaration of Conformity
  • Appendix

Differences between the Technical File and Design Dossier

At a broad level, in general terms, while the Technical File is for MDD Class I and Class II a or II b; the Design Dossier is for MDD Class III devices

While Technical Files are retained in the premises of the manufacturer or the Authorized Representative for review of the Competent Authorities or/and Notified Body; Design Dossiers need to be submitted to the Notified Body for review before the product gets its CE-marking.

 

Learn more on this topic by visiting  :  http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900746SEMINAR?wordpress-SEO

 

 

Technical file vs design dossier

One of the important points that a medical device professional encounters is this: the technical file vs design dossier. The reason for the confusion about these two is that there are different names of the same concept and vary according to the class of device and the Notified Body that approves it. This is what has given rise to the technical file vs design dossier.

Depends on class of device

At a basic level, there is a difference between the two: the medical device manufacturer must have technical documentation for each device. Called the conformity assessment annex of the MDD, IVD and AIMD directives; this is a basic requirement of these regulatory bodies and statues. The important element of the technical file vs design dossier aspect is that the terminology technical file/design dossier sometimes varies depending on whom the directive has come from, and the annex in which it is placed. This is why there is some confusion on this technical file vs design dossier matter.

The two terms are interrelated

The following description should give a perspective: by the term “technical file” is meant the description of the documentation that demonstrates the ways by which the device complies with essential requirements. Among these devices, some devices require a design examination. The Technical Construction File (TCF) of such devices is called a design dossier. This explains the fundamentals of the technical file vs design dossier debate.

Depends on the Notified Body

To recap, the technical file, which the MDD refers to as “technical documentation”, is a bunch of documents that the medical device manufacturer has to put in place and furnish to their Notified Body for assessment. This is to show that the medical device conforms to the Essential Requirements of the directive. While this much is clear, some Notified Bodies require different methods of documentation for certain class of medical devices. These are to be presented as a design dossier. This is what has given rise to some confusion about the technical file vs design dossier issue.

Reference:

http://www.tuvamerica.com/tuvnews/newsletters/searchdetail.cfm?ID=552

http://elsmar.com/Forums/showthread.php?t=28968

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