Verification vs validation is a key understanding for regulatory professionals

For regulatory professionals, aspects of verification and validation, such as how to get verification and validation right, and an understanding of the ways in which verification and validation diverge from each other and converge, make up very important learning. The key point is that verification and validation should be risk based and be built keeping in mind the extant regulatory expectations.

risk-management

Building a verification and validation process that sufficiently uses targeted and documented risk based verification and validation test case elements or scripts is the foundation to this. All these have to be reviewed against ISO 14971 and ICH Q 9 hazard analysis and product risk management.

Getting their V & V right involves gaining and exercising proper knowledge of these areas on the part of professionals working in regulatory environments. This learning is what a two-day seminar by GlobalCompliancePanel, a very well-known provider of professional trainings for all the areas of regulatory compliance, will impart.

V & V against the regulatory process

The Director of this seminar, John E Lincoln, a senior Consultant for Medical device and Regulatory Affairs, will explain the rationale behind verification and validation and clear all the ambiguities relating to this activity.

He will help participants to understand the following:

  • Evaluating different field-tested, U.S. FDA-reviewed V&V protocols
  • Ways by which to employ equipment/process Requirements Specs/DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500. John E Lincoln will help participants how to do all these against a background of limited company resources
  • Reviewing a matrix that simplifies “as-product”, “in-product”, process and equipment and related matters
  • Software VT&V to ensure that key FDA requirements are not overlooked

To enroll for this course, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900645SEMINAR?verification-vs-validation-qms-Las-Vegas.

The Director will also offer hands-on understanding of Quality Management Systems and 21 CFR Part 11. This seminar will help participants:

quality-management1

  • Understand Verification and Validation, differences and how they work together;
  • Know how to document a “risk-based” rationale, and use it in a resource-constrained environment;
  • Determine key “milestones” and “tasks” in a project;
  • Locate and document key subject “inputs”;
  • Compile “generic” Master and Individual Validation Plans;
  • Learn the key element of a Product V&V File/Protocol;
  • Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;
  • Get a grasp of basic Test Case construction;
  • Understand sample sizes and their justification;
  • Learn the key elements of Software V&V expected by the FDA and how to document;
  • Deal with hardware and software vendors, sales and marketing
  • Consider a field-tested software V&V documentation “model”;
  • See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11.

Understanding the calibration curve

To get an understanding of instrument calibration, we can think of it as being an essential phase in most measurement procedures. The calibration curve is a set of operations with which the relationship between the outputs of the measurement system (for example, the response of an instrument) and the accepted values of the calibration standards (for instance, the amount of analyte it has) can be established. Understanding the calibration curve is important because this is required in a large number of analytical methods.

How to go about a calibration curve?

At its most basic form, understanding the calibration curve has to begin with the preparation of a group of standards which contain a known amount of the analyte of interest. In this, the instrument response for each standard has to be measured. In addition, the relationship between the instrument response and analyte concentration has to be established. This relationship is then used to transform measurements made on test samples into estimates of the amount of analyte present.

The calibration process

In understanding the calibration curve, we have to know that a number of stages go into calibrating an analytical instrument. This is how a logical sequence of steps would look:

  • Planning of the experiments;
  • Making the relevant measurements;
  • Plotting the results;
  • Carrying out regression analysis on the data, which will help obtain the calibration function;
  • Assessing the results of this regression analysis;
  • Using the calibration function to estimate the values of the test samples;
  • Evaluating the ambiguity of the values obtained

References:

http://www.nmschembio.org.uk/dm_documents/lgcvam2003032_xsjgl.pdf

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

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

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

Supplier quality audit training

Most medical device companies have auditors that assess the quality of the product from the supplier. This is the supplier quality audit. Supplier quality audit training is the training that is needed to be qualified to assess the quality of a product from the supplier. Auditors, regardless of whether they are from inside the organization or are external; have a need for this kind of training.

What are the attributes of an effective supplier quality audit training?

For a supplier quality audit training to be effective, it has to ideally combine theoretical and practical aspects of supplier quality audit. Auditing staff that undergo training must ideally be made to carry out a number of assignments in the area of regulatory compliance relating to supplier quality audit. This will give them enough knowledge of how the course aspects of supplier quality audit training work in real life.

What types of audits can supplier quality audit training help an auditor perform?

When proper supplier quality audit training is imparted, auditors in the organization or outside can perform the following types of audits:

  • New supplier audits
  • Existing supplier audits
  • Time cycled audits
  • Internal audits
  • Audits specific to a task or cause

Areas of supplier audits

There are specific areas that supplier audits work in. The aim of supplier quality audit training is to identify these and help auditors carry the audits out in their respective areas:

  • Regulatory
  • Quality
  • Operations
  • Business
  • The supplier audit process

Effective supplier quality audit training will help auditors carry out two important types of audit:

  • Top-down, which is an ISO-type of audit that is concerned with recordkeeping and Quality System documentation
  • Bottom up, a style of audit in which specific quality deficiencies are identified and rectified. This is usually referred to as the FDA type.

References:

http://www.nixonpeabody.com/files/Supplier_Quality_Mailhot.pdf

 

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

Supplier qualification program

In the pharmaceutical and life sciences industries, a sound supplier qualification program is a must. It is an indispensable element of their very reputation. Many pharmaceutical organizations contract several of their manufacturing processes or even products to third parties. For this reason, the FDA considers the supplier as a logical extension of the manufacturer. In fact, it attaches so much importance to this area that it holds the pharmaceutical organization (the contracting company) responsible for the supplier’s behavior in relation to the manufacturer’s product

The FDA can inspect the supplier’s facility too

Since the supplier is considered a part of the manufacturer’s operations, the FDA reserves the right to inspect the supplier’s facility too, at the time of carrying out an inspection of the pharmaceutical organization. This being the importance of the supplier, it is imperative to chalk out an effective supplier qualification program that meets regulatory requirements.

Supplier evaluation

A supplier qualification program starts with supplier evaluation. Obviously, the supplier and his facilities have to be inspected according to predefined parameters. This will enable the pharmaceutical organization to clearly state the terms of the contract. The contract should ideally specify the conditions in which the pharmaceutical product is going to be made.

Key elements of a sound supplier qualification program

All the important aspects of a supplier qualification program have to be put in place, as should the kind and nature of control. There should be proper checking up of data that goes into the supplier qualification program. These are some of the aspects that need to be implemented:

  • Establishment and maintenance of data that clearly describe or reference the specified requirements, among which quality requirements are very important
  • Identification of the key elements of a strong, sustainable and successful supplier qualification program
  • Signing of terms of the contract and making written agreements of the same, in which all the conditions of work will be clearly specified and ensure that the supplier meets the quality requirements consistently
  • Ensuring that the supplier qualification program has processes that are important to quality. This should also define how conformance to manufacturer requirements will be monitored and verified.

Reference:

http://www.eventbrite.com/event/5766556927/eorg

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

Quality by Design (QBD) and analytical methods

Quality by Design (QBD) and analytical methods have come into focus because of an inherent limitation in the guideline used for validation of analytical methods. The International Conference on Harmonization (ICH)’s Q2 guideline, Validation of Analytical Procedures: Text and Methodology serves as the guiding document for validation of analytical methods for pharmaceutical products. Since the most common approach to method validation is a one-time affair, there is need for guidance on how to implement continuous and consistent method performance.

Methods fail to perform as required or intended in the receiving laboratory because there is always the absence of an effective process for capturing and transferring the knowledge of those involved in the development. With too much emphasis on validation of the methods to meet regulatory requirements, the focus on what to do to make the process work during actual application seemed to be lost. It is to address this bottleneck that Quality by Design (QBD) and analytical methods took shape.

How do Quality by Design (QBD) and analytical methods make a difference?

QBD, in being “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management”; emphasizes the importance of having predefined objectives built into the development process. An analytical method, which is an analytical procedure that includes all steps in the procedure, constitutes an important step in the QBD lifecycle approach. Together, Quality by Design (QBD) and analytical methods become an important component of the three-stage process of method validation, which are:

  • Stage one, which relates to method design
  • Stage two, which relates to method qualification, and
  • Stage three, which is about continued method verification

 Reference:

http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=791903

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

Process validation for medical devices

The FDA introduced the idea of process validation for medical devices with the idea of improving the quality of pharmaceuticals and medical devices. From its rudimentary form that was conceived in 1987, process validation for medical devices has undergone changes to accommodate more types of devices and more processes into the validation.

Why is process validation for medical devices necessary?

In simple terms, validation is the ability of a medical device to demonstrate that a procedure, process and activity will consistently lead to the expected results. For the FDA; process validation for medical devices is all about establishing documented evidence which will offer a high degree of assurance that a specific process will consistently produce a medical device product that meets its pre-determined specifications and quality characteristics.

Process validation for medical devices is a requirement of the current GMP regulations for medical devices, 21 CFR Part 820 and is applicable to the manufacture of medical devices.

Factors

A host of factors influences the quality of a product in medical device manufacturing. Some of these are:

  • Adequate product and process design
  • Control of the process
  • In-process and end-product testing
  • Selection of quality parts and materials

The guidelines published by the FDA provide a framework for medical device manufacturers to build a holistic approach to process validation for medical devices. This is broad in nature, since the particulars of process validation vary from one manufacturer to the other because of many factors, such as

  • The nature of the medical product (e.g., sterile vs. non-sterile)
  • The complexity of the process
  • The local regulatory requirements
  • The age of the product (e.g., new invention vs. similar to an existing product)

The FDA recommends that the manufacturer:

  1. Prepare a written validation protocol  which specifies:
    1. The procedures to be conducted and the data to be collected
    2.  Purpose of data collection
    3. A sufficient number of process repetition to demonstrate reproducibility
    4. An accurate measure of variations during repeated process runs
    5. The test conditions that include best case and worst case scenarios called as “most appropriate challenge” conditions
    6. Validation documentation requirements to include evidence of the suitability of materials and the performance and reliability of equipment and systems
    7. Monitor and document key process variables and analyze the data collected to establish:
      1. The variability of process parameters for individual runs
      2. Whether or not the equipment and process controls are adequate to assure that product specifications are met
      3. Utilize finished product test data and in-process test data to obtain quality attributes and in establishing variability
      4. Where finished (or in-process) testing cannot adequately measure certain attributes, process validation should utilize the details of each system in production and by document the observed results

Reference:

http://www.fda.gov/downloads/Drugs/…/Guidances/UCM070336.pdf

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122439.htm

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539