Design of Experiments (DoE) for Process Development and Validation

Design of Experiments (DoE) is a very important process development and validation component in several kinds of industries. DoE for process development and validation involves carrying out a number of tests recurrently and steadily over a period of time. Its responses are then observed.

DoE is important for process development and validation as it offers an understanding of the predictability and reproducibility of an experiment. Fundamentally, Design of Experiments for process development and validation seeks to rule out fluke or chance in the methods needed for bringing about control for a product.

DoE in medical devices

In the area of medical devices, guidelines for Design of Experiments for process development and validation are set out in the Global Harmonization Task Force (GHTF) Process Validation Guidance for Medical Device Manufacturers. This document offers guidance in the area of Design of Experiments for process development and validation by suggesting the exact areas in which design of experiments should be applied during Process Validation.

The GHTF guidance also suggests the use of both screening and response surface designs during Operational Qualification. It further requires Design of Experiments for process development and validation to be used during various phases of design controls. These include:

o  Design and development planning

o  Design verification

o  Design validation

o  Design transfer

o  Design changes.

Get a full understanding of Design of Experiments for process development and validation

The ways of approaching Design of Experiments for process development and validation will be topic of a two-day seminar that is being organized by GlobalCompliancePanel, a highly respected provider of professional trainings for the areas of regulatory compliance.

Jim Wisnowski, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director at this seminar. In order to gain a full understanding of the principles and application of Design of Experiments for process development and validation; please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900794?linkedin-SEO .

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All about Design of Experiments for process development and validation

This seminar will offer total and all-round understanding of all the aspects of Design of Experiments for process development and validation.

Process development studies need to be completed before a process control plan is developed as part of an overall risk management strategy. These process development studies help gain knowledge and understanding about the impact of variation in process parameters on the variation in the product quality characteristics of the product.

An explanation of the methods used

The methodology of Design of Experiments for process development and validation offers a means for identifying process parameters, which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes.

Design of Experiments for process development and validation uses screening designs such as 2k factorial and D-optimal designs to determine critical process parameters. Design of Experiments for process development and validation use response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs for fashioning the functional relationship between those critical process parameters and the critical quality attributes.

A primer on statistical analysis

This seminar on Design of Experiments for process development and validation will present a primer on statistical analysis, during which it will focus on the methods required for analysis of designed experiments. Jim will then move on to the steps to a proper DoE, during the process of which he will demonstrate the nature and uses of important risk management tools such as Ishikawa and FMEA, which can be used pre and post DOE studies.

The Director will also teach how to generate and analyze multiple screening and response surface designs, and why and how each are used. After teaching participants how to present the results, Jim will explain how to update the risk management tools using the results of the studies.

This session on Design of Experiments for process development and validation will cover the following areas:

o  Identify critical quality attributes (CQAs) that will be used as responses in your designs

o  Utilize risk management tools to identify and prioritize potential critical process parameters

o  Identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs) using both screening and response surface designs

o  Be able to design and analyze screening designs including a factorial, fractional factorial, and D-optimal design

o  Understand the need for adding center points to a design

o  Be able to design and analyze response surface designs including central composite designs (CCDs), Box-Behnken designs, and I-optimal designs

o  Present results of DOE studies

o  Use systematic understanding from DOE studies to update the control plan that is part of the overall risk management plan.

GlobalCompliancePanel Professional Training and Development Courses with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till March 31. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit http://www.globalcompliancepanel.com/ and use MGCP50 Promo Code.

This offer is valid till March 31, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

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Article on Effective techniques for extracting information from geochemical data are largely ignored by the industry

In the area of geochemical data analysis techniques and obtaining geochemical extracting information; most mining specialists strongly recommend an approach that goes beyond merely asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis. There, however, exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information. But these are largely ignored by the industry.

As a result of following only one method and technique for geochemical data analysis and obtaining geochemical extracting information, an average geologist is not generally well trained on the necessary techniques and methods. Whenever a request for such data mining techniques analyses comes up, the geologist is short of the techniques and methods needed for geochemical extracting information, including the use of compositional data analysis. This results in failure in the endeavor of extracting all the geochemical data analysis information contained in the data.

Insight into how to use geochemical data analysis techniques and obtaining geochemical extracting information

Noting the deficiency in the methods used for optimal geochemical data analysis techniques and obtaining geochemical extracting information; GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, is organizing a two-day learning session that inculcates the right learning in this area.

At this seminar, Ricardo Valls, a professional geologist with thirty years in the mining industry, will be the Director. He brings the vast wealth of experience of the extensive geological, geochemical, and mining experience, managerial skills, research techniques, and training he has gained by carrying out various projects globally, into this seminar. To benefit from this seminar, please register for it by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900828?linkedin-SEO . This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Simplifying the geochemical extracting information to make sense

Geologists, Geochemists, Exploration personnel, Graduate students and Postgraduate students will find this course very useful, as it will give them an understanding of how to simplify and make sense of the geochemical extracting information. The speaker will demonstrate all types of analyses that can be requested. This will help participants in their exploration goal of finding the new ore body.

This seminar will help mining professionals understand how to extract all the important information of their data, including the use of compositional data analysis.

Valls will cover the following areas at this seminar on obtaining geochemical extracting information:

–       How to determine the type of sampling

–       How to determine the type of assays

–       General processing of the data

–       Compositional Data Analysis

–       Representing the results

In the process of explaining the ways of obtaining geochemical extracting information; Valls will set the following agenda for this seminar:

How to determine the type of sampling

·                    Mechanical anomalies

·                    Chemical anomalies

·                    Chemo-mechanical anomalies

·                    Scale of work

How to determine the type of assays

·                    What are you looking for?

·                    What the laboratory can offer?

QA&QC in the field and in the laboratory

·                    QA&QC in the field

·                    QA&QC in the laboratory

General processing of the data

·                    Preparing the data

·                    The problem of zeros and b.d.l. data

·                    Hurricane values

·                    Distribution law

·                    Preparing the data for further analysis.

Compositional Data Analysis

·                    Brief introduction

·                    Comparing CDa with normal statistics

·                    ALR

·                    CLR

·                    ILR

Processing major elements

·                    Statistical processing

·                    Determining the most probable magmatic event.

Processing trace elements

·                    Statistical processing

·                    Estimating the erosional level

·                    Determining geochemical indexes

Graphical representation of the results

·                    Variograms

·                    SURFER

Complaint Handling, Medical Device Reporting and Recalls

Complaint Handling, Medical Device Reporting and Recalls are important aspects of a medical device.

Complaint handling is a crucial element of any Quality System. If a complaint comes out from a user about a product after it has passed through FDA scrutiny, it is an indication that something needs to be looked at and that the complaint has to be addressed.

Putting in place an effective complaint handling system is an imperative for the medical device manufacturer and a requirement from the FDA. Complaints are an important indicator of the kind of products manufacturers release into the market. They are a very important standpoint from which devices are evaluated, investigated and analyzed, so that corrective action can be taken.

The complaint evaluation should serve as an indicator

A complaint handling system has to be put in place to help the manufacturer comprehend a gamut of issues concerning complaints. The validity of the complaint, the root cause of the complaint, and preventive action taken are important ones among these.

Look for the trend

Ignoring or glossing over complaints is something no medical device manufacturer that is serious about its business and is professional can afford to do. In fact, medical device manufacturers should look to complaints as being an important pointer of problems and issues with the design, use and/or manufacture of a product. It is possible that just one complaint that is fully investigated and properly handled could lead to corrective action from the manufacturer.

So, the trend is an important aspect of a medical device complaint handling system. The trend helps the manufacturer zero in on the specific cause for complaints. This, however, is not easy as it appears, because the medical device manufacturer may need to analyze a wide variety of complaints. It is only this comprehensive exercise that may sometimes lead to swooping in on a defect.

This exercise of spotting the trend is crucial for getting a hold of the precise locus of the problem in the Quality System. The trend could be anywhere ranging from the product to the labeling or to the packaging or its distribution.

Imparting understanding of Complaint Handling, Medical Device Reporting and Recalls

The important aspect of trend spotting in medical device recall and its associated aspects will be covered at an important learning session on this topic that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this two-day seminar, David R. Dills, Global Regulatory Affairs & Compliance Consultant who provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers, will be the Director. Full knowledge of all the aspects of medical device complaint handling can be gained by registering for this seminar. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900758?wordpress_SEO for this.

The MDR and the Recall

David will also take up other important aspects of the medical device Quality System: The MDA and medical device recalls. The Medical Device Reporting (MDR) is the FDA’s mechanism that enables it to receive adverse events about medical device from manufacturers, user facilities and importers. The MDR system is aimed at helping the agency detect and correct adverse events quickly.

User facilities such as nursing homes and hospitals are required to report suspected medical device related serious injuries to the manufacturer and suspected medical device related deaths to both the FDA and the manufacturers. In cases where there is no information about the manufacturer, these injuries have to be reported to the FDA itself.

The FDA has an elaborate reporting system for all categories of medical devices, such as manufacturers, user facilities, distributors and manufacturers. David will offer learning on all these aspects of complaint handling.

The Medical Device Recall    

The Medical Device Recall is the method by which a medical device is taken out from the market and/or corrected whenever the FDA determines that the device, if it is left to continue in the market, has the potential to cause anything from serious and adverse health consequences to death. One can understand Medical Device Recall as an action taken with the intention of addressing a problem with a medical device that has violated applicable FDA law.

These are the situations in which Medical Device Recalls happen:

1) Because of a defect in a medical device;

2) The device’s potential to pose a risk to health, or

3) When it has a defect and is a risk to health.

David will offer clarity on all these aspects of Medical Device Recalls.

Applying ISO 14971 and IEC 62304 to medical device software

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Risk management of software used in medical devices has to be implemented diligently, completely and correctly, scrutinizing the gaps thoroughly and correcting them right from the very start of product development. This is critical because of the following reasons:

  1. Medical products that have gaps or are implemented incorrectly or incompletely suffer serious ailments such as impediments or delays in production. Further, such products fail to get the required certification and/or approval;
  2. Given the close linkage between most activities and the development lifecycle; almost no activity can be isolated and performed with retrospective effect after detection of a gap. As a result, all the activities performed till the identification of gaps become unproductive and redundant. When this happens, the company has to start from the beginning, irrespective of the stage at which an anomaly gets detected, incurring huge delays and cost overruns.

The solution to these problems is to embed software risk management into the bigger scope of overall risk management. This is the only real solution to problems associated with faulty product development. Globally applicable standard requirements such as ISO14971 and IEC62304 are major guidelines that help medical device companies get the risk management of software used in medical devices right. These standards have made risk management central to and a mandatory component of almost any activity in the medical device industry.

Getting it right from start till finish

Regulatory requirements set out in ISO14971 and IEC62304 standards that deal with risk management of software used in medical devices need to be implemented in the right manner, if medical device companies have to clear regulatory hurdles and meet quality standards. Expert professional trainings that help them do this will give them an understanding of how to design, implement and test critical medical device software in a regulatory compliant environment.

All these will be part of a learning session that is being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the regulatory compliance areas. This two-day, live seminar will have Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, as the course Director.

To gain the benefit of expert training from the Director of this seminar; please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900750?wordpress_SEO  to register.

Globally applicable standard requirements

Markus will explain the requirements set out by international consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, which has led to risk management being a mandatory component of almost any activity in the medical device industry.

Since the need to embed software risk management into the bigger scope of overall risk management is a critical aspect; Markus will introduce all the steps needed for designing, implementing and testing core medical device software in a regulatory compliant environment, even as they adhere to the principles of risk management. Another important learning Markus will impart is system level risk management and the resulting interfaces to software.

The safety case method

A well-established method for collecting and consolidating all safety related information together in one location, so that all risk related activities are comprehensively summarized, and the safe properties of a device demonstrated, is what is called the ‘Safety Case’ or ‘Assurance Case’ document.

Although as of now, the FDA requires this method for only infusion pump submissions; this system of documentation is almost certain to become standard practice in the future across all devices that come up for approval. At this course, Markus Weber will introduce the basic concepts and content of safety assurance cases. He will also explain and illustrate their utility for internal and external review of safety related information.

Tips for practical application of risk management principles

Real-life examples and proven tips and tricks that make the application of risk management practical and beneficial will be offered at this webinar. The Director will describe the system level issues of risk management as well as the increasingly important software related issues of critical systems.

He will introduce the concept of an assurance case to make the combined effort needed to design, implement and verify a safe device transparent. An important outcome of this learning is that it will help participants to meet and comply with regulatory requirements with highly lessened overheads and resource burdens.

Ensuring that analytical data in laboratories are accurate, reliable and consistent

Ensuring that analytical data are reliable, consistent and accurate is the fundamental reason for which analytical methods and procedures need to be validated. The employment of proper scientific methods and procedures by laboratories and validating them ensures the reliability, consistency and accuracy of the analytical data.

The purpose of doing so is to corroborate the suitability of intended use of a particular test and to confirm that the product produced in the laboratory meets the requirements of quality, purity, identity and strength in the required and set measure.

The imperative for validation of analytical data

The reason for which analytical data has to be validated for the criteria described above can be summarized in the following:

o  Because of the direct relationship it has to the quality of the data it validates;

o  To make sure that the analytical data is trustworthy;, and

o  Finally, validation, verification and transfer of analytical methods are a regulatory requirement, as set out by the different regulatory bodies such as the FDA and the EMA, and standards such as the USP and ICH.

Method validation and compendial methods

Of late, method validation has been receiving very high attention from both regulatory agencies and industry task forces alike. Both the FDA and the EMA have recently released guidelines on method validation and transfer. In addition, USP has suggested new chapters for approaches to the following:

o  Integrated validation

o  Verification and transfer of analytical procedures

o  Equivalency testing and for statistical evaluation.

What about compendial methods?

The verification of compendial methods is needed to demonstrate two aspects:

o  The suitability of laboratories to successfully run the method, and

o  To demonstrate through testing that transfer of methods, when carried on between laboratories, is successful. When a laboratory intends to use an alternative method in place of a compendial method, verification of compendial measures should establish the equivalency of the alternative method.

Comprehensive learning on validation, verification and transfer of analytical methods

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance will address all the issues relating to validation, verification and transfer of analytical methods. At this seminar, Ludwig Huber, the director and editor of Labcompliance, the global online resource for validation and compliance and highly respected author of several books on compliance, will be Director.

To gain the full knowledge of all areas relating to validation, verification and transfer of analytical methods; register by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900858?linkedin-SEO .

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Contents of the two-day seminar

Over the course of these two days, Huber will equip participants with the background needed for getting a proper understanding of the requirements that need to go into validation, verification and transfer of analytical methods. An even more significant learning he will offer is the one on strategies needed for this.

He will provide tools to implement most critical requirements. Also provided are templates and examples for developing inspection-ready documentation. Interactivity will be a major component of this seminar. Huber will sprinkle workshop exercises into and between the presentations. Around half of the total time will be dedicated to practical sessions with real life examples.

An additional bonus for participants is the assortment of tools the Director of this seminar will offer, such as SOPs, validation examples and checklists, all of which will be made readily available on a dedicated website, and which can be used to easily implement the learning gained in the course.

Quality audits for the medical device industry

Quality management systems of medical devices have to go through well-defined quality audits. Medical device companies need to implement these in order to show compliance with quality.

ISO 13485 is the quality management standard for medical devices. Based on the process approach of this document and that of 21 CFR part 820 the Global Harmonization Task Force (GHTF) has set out processes for audits relating to the quality management systems of medical devices. The GHTF believes that insertion of quality management system requirements based on ISO 13485 is a first step towards global harmonization of medical devices. These guidelines are meant to lead regulators into articulating regulatory systems for medical devices.

Purpose of quality audits according to GHTF

The GHTF spells out the rationale for carrying out quality audits for the medical device industry. The benefits of carrying these out can be seen in the following:

  • Assurance that a high quality medical device will be made available
  • Quality audits for the medical device industry make available a harmonized, consistent standard that can be used by future generations
  • These audits are independent, verifiable and objective assessment of the manufacturer’s compliance with regulatory requirements
  • The results of these audits can serve as an important guide for marketing medical devices.

Definition of quality audit

GHTF describes the quality audit as the organizational responsibilities, processes, structure, resources and procedures taken to implement a quality management system.

What should the quality management system cover?

The QMS in a medical device organization should cover the following:

  • Control of documents
  • Control of records
  • Management review
  • Internal audits
  • Corrective and preventive action

General requirements for organizations that audit

GHTF lists a few general requirements from auditing organizations. These include:

Audit types

Apart from describing the audit scope and methodology in detail; the GHTF also has a description of the types of quality audits for the medical device industry. They are:

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