Human factors as a factor in medical devices 2017

The ANSI/AAMI HE75:2009 document describes human factors as the way in which the elements of human knowledge, such as emotional, intellectual, and physical and the sensory are used to optimize the production of devices, systems, and many others concerned with them. Human factors take not only the ways in which these human elements are used to raise productions, but also the way in which the limitations of these factors come into play. It is a field that is essentially concerned about the interaction between humans and devices or machines.

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Given the nature of this description, it is not surprising that human factors are important to areas such as design and aesthetics. It is an important aspect of user interface. User interface has gained a lot of acceptability and popularity following the emergence of the field of IT, but it can be used in a number of other areas. Since there is almost no area of production or science in which the user does not come into the picture; human factors can be a major factor in creating and shaping user interface for a number of products.

A major factor in medical devices

In the area of medical devices, human factors come into play in a prominent way. Although, strictly speaking, medical devices are not products into which the aesthetics is considered critical in determining consumer behavior in the way it is for say, clothing; design is an indispensable factor. Design plays a very major role in the user interface of medical devices, because these products have to be designed to absolutely precise specifications. A small deviation or variation can cause harm to humans, given the nature of the uses of medical devices. Errors can result in major consequences for patients, and subsequently, to the organization manufacturing the devices.

When it comes to medical devices, the FDA has the primary responsibility of regulating them with the intention of ensuring their safety and effectiveness. Incorporating the principles of human factors into medical devices ensures that the product meets specification, design and quality standards and thus becomes faster and less expensive to market. On account of this, human factors are becoming part of the design and development, as well as of the supplementary aspects of medical devices, such as Instructions for Use, labeling and even training.

FDA’s regulations talk about human factors in medical devices

21 CFR 820.30 emphasizes that human factors need to be taken into consideration for the following:

–       Design input: Ensuring that the needs of the patient and any others who may use the product are taken into consideration

–       Design verification: Making sure that the criteria for performance set for the medical are being consistently met, and

–       Design validation: Ensuring that the device conform to predefined user needs as well as intended uses, as also making sure that testing is carried out to ensure this function. Software validation and risk analysis are part of this testing.

In addition, the FDA has also emphasized the area of human factors in medical devices in many guidance documents and a number of upcoming Draft Guidance documents.

Explore the area of human factors in medical devices

Curious about how human factors play a role in medical devices? Want to explore the area in-depth and stretch your knowledge and imagination of human factors in medical devices? A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance will offer this learning.

The Director of this seminar is Virginia A. Lang, Principal and Founder HirLan, Inc. and HirLan International SA. Over the course of these two days, Virginia will cover all the important areas relating to human factors in medical devices. To enroll for this important learning session, just log on to

Human Factors and Predicate Combination Products. 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 complete explanation of regulations and uses of human factors in medical devices

The core aim of this seminar is to familiarize participants with the way in which human factors can be applied into medical devices. Towards covering this, she will explain all the current and upcoming human factors requirements, using which, participants will learn how to keep costs under control and reduce the time for the manufacture and marketing of their products. Those in charge of crucial functions in medical devices, such as Quality Assurance, Regulatory Affairs, Device Engineering, Device Manufacturing and Pharma/Medical Devices will gain a great deal of learning from this seminar.

Virginia will cover the following areas at this seminar:

o  Overview of Human Factors and the FDA perspective

o  Human Factors Methods and Device Product Life Cycle

o  Human Factors and Risk Analysis & Management

o  Human Factors: What Devices Require Human Factors Evaluation and Validation?

 Human Factors and Combination Products

o  Human Factors and Combination Products Submitted in an ANDA.

Applied Statistics for FDA Process Validation

The pharmaceutical industry considers Applied Statistics for FDA Process Validation to be of very high importance. In 2011, the FDA set out this guidance for the industry. as part of this guidance, called “Process Validation: General Principles and Practices”, which sets the framework for Process Validation in the pharmaceutical industry, any organization in the pharmaceutical industry has to set up a three-stage process.

These are the three stages:

I.           Process Design

II.           Process Qualification, and

III.           Continued Process Verification.

Stage 1, or what is called the Process Design stage, is the stage in which the commercial manufacturing process is defined. This definition is based on knowledge gained through development and scale-up activities.

Stage 2, called the Process Qualification, is the stage in which an evaluation is made of the process design to determine if the process is capable of reproducible commercial manufacturing.

Stage 3, the Continued Process Verification, is meant for giving ongoing assurance during routine production to ensure that the process remains in a state of control.

A seminar on the ways implementing Applied Statistics for FDA Process Validation

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

In order to learn Applied Statistics for FDA Process Validation in-depth, please register by visiting Applied Statistics for FDA 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 detailed and methodical approach to implementing statistical methodologies

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

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

Dr. Burdick will next move on to explaining the two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays).

He well then show how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Given that 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.

This seminar on Applied Statistics for FDA Process Validation will 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.

All-round learning related to Applied Statistics for FDA Process Validation

Dr. Burdick will teach participants how to:

o  Apply statistics for setting specifications

o  Assess measurement systems (assays)

o  Use Design of Experiments (DOE)

o  Develop a control plan as part of a risk management strategy, and

o  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 established for the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation also provides a useful framework for other related industries.

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

o  Apply statistics to set specifications and validate measurement systems (assays)

o  Develop appropriate sample plans based on confidence and power

o  Implement suitable statistical methods into a process validation program for each of the three stages

o  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)

o  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

o  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.

A Tour of the FDA 2017

Businessman uses smart watch and phone.

A tour of the FDA is something like a snapshot of what the FDA does. The importance of the FDA can never be understated: It regulates products from the proverbial pin to airplane in the food, medical devices, pharma and healthcare industries, which touch almost every aspect of American lives. The products that the FDA regulates account for about a trillion dollars, which make up about a quarter of all goods traded in the US.

So, what is a tour of the FDA like?

A tour of the FDA helps to get a broad understanding of the this regulatory body and get some idea of the various departments it has, as well as the functions of these departments. To get an understanding of what the FDA does, a reference to its mission statement could give some direction:

“(The) FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” This is just the opening line of the FDA’s mission statement. Reference to its other statements, which have now included a reference to containing terrorism, will serve as a good guide to a tour of the FDA. In short, the FDA regulates nearly every item used and consumed by the American public.

The history of the FDA

The legal sanction for carrying out its mission is mandated by the Federal Food, Drug and Cosmetic Act (FD&C Act). An amazing fact that a tour of the FDA reveals is that it is one of the oldest regulatory bodies in the world, with its earliest jurisdiction having covered regulation of drugs in the year 1848. The Department of Agriculture, to which President James Polk appointed noted chemist Charles Wetherill, can be considered the earliest endeavor to regulate medical products of daily use in the US.

How is the FDA organized?

A tour of the FDA is incomplete without a reference to the way it is organized. Its structure consists of this hierarchy:

  • Office of the Commissioner
  • Office of Foods and Veterinary Medicine
  • Office of Global Regulatory Operations and Policy
  • Office of Medical Products and Tobacco
  • Office of Operations

Under these broad heads, a tour of the FDA shows the way into which it is divided into several offices and organizations. Important among these include:

  • Office of Regulatory Affairs (ORA)
  • Center for Food Safety and Applied Nutrition (CFSAN)
  • Center for Drug Evaluation and Research (CDER)
  • Center for Biologics Evaluation and Research (CBER)
  • Center for Devices and Radiological Health (CDRH)
  • Center for Devices and Radiological Health (CDRH)
  • National Center for Toxicological Research (NCTR)

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The FDA’s requirements for Drug Applications and Submissions

The FDA has set out requirements by which it accepts drug applications and submissions. It accepts drug applications and submissions through two formats, the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). The NDA and the ANDA are the mediums through which the FDA eventually approves drug applications and submissions.

The NDA process

The NDA is one the two mechanisms through which the FDA accepts drug applications and submissions. This application is available with the FDA. Any sponsor of a clinical study, be it an organization or an individual, can apply for the NDA and can submit the same, when it is convinced that it has sufficient evidence that its study meets the FDA’ requirements for marketing approval.

The way to go about filing for an NDA as part of drug applications and submissions is this:

The ANDA process

The ANDA is the other method of drug applications and submissions to the FDA. Being the counterpart of the NDA; the ANDA is the application a company makes for getting a generic drug approved by the FDA for marketing. The ANDA also has to contain the same data as contained in the NDA drug applications and submissions, but is not required to be accompanied by the data of the clinical research. It is for this reason that they are called by their name.

In place of the clinical research data, the ANDA format of drug applications and submissions has to contain evidence that the product has the ability to perform the same functions of the original drug. This is called the drug’s bioequivalent value. Like in the case of the NDA, the ANDA too is allocated a reference number as part of its drug applications and submissions.

Common factors taken into consideration

In either of these methods, the primary considerations for the FDA include the following:

  • The safety and effectiveness of the drug
  • Its ability to meet its intended use
  • Its ability of its benefits to outweigh its risks
  • The appropriateness of the drug’s planned labeling and its contents
  • The ability of the methods used in the manufacturing of the drug to meet Good Manufacturing Practice (GMP)
  • The capacity of the drug to have to controls in place for maintaining its quality, purity, strength and identity

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New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and adherence to them

The U.S. Food and Drug Administration (FDA) is in the process of finalising food safety rules. A major part of these rules is devoted to the ways by which to ensure scientific and safe transportation and logistics food transportation. The FDA is required to establish rules for that improve, audit and enforce new rules relating to food transportation. This is something required by the Food Safety Modernization Act (FSMA), under congressional instructions.

Many aspects of food transportation come under the ambit of these new FSMA Rules. These include:

–       Foods not completely enclosed by a container

–       Prevention and reduction in adulteration and risk

–       Personnel training and certification for this purpose

–       Inspecting food and collecting data

–       Maintaining compliance and reporting about its evidence.

How to do this right?

Comprehension of all the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods is necessary and important for organizations that work in food transportation. They also need to know how to implement these rules. It is this understanding that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer at a seminar it is organizing.

The Director of this two-day seminar is John Ryan, President, TransCert, QualityInFoodSafety, RyanSystems. To gain insights into how to understand all the aspects of the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and to understand how to comply with them, just register for this session by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900810?wordpress-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

At this seminar, the Director will arm participants with an understanding of the legal requirements of food transportation and how to develop a company plan that meets the expectations and requirements of both its customers and the FDA. Also offered is total understanding and review of the ways of establishing the right temperature monitoring, sanitation, container test and traceability, training and data reporting procedures.

Technological aspects of FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

Technological aspects of food transportation are gaining importance. These include new low cost GPS enabled traceability and temperature monitoring technology, EPA approved container sanitizers, washout technologies, temperature maintenance equipment, and food residue and bio-contaminant testing. FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods have a close relationship with these. The Director of this seminar will take these up for examination.

In reviewing the future of transportation food safety in the light of new and evolving technologies; the Director will dot the seminar with references to upcoming technology providers and provide Internet links to detailed information on the same.

This seminar is immensely useful for food supply chain logistics and food safety and security personnel whose primary responsibilities include management, sanitation, quality and operations. Those involved with handling incoming and outgoing food shipments, maintaining transportation equipment and tools, and purchasing or selling will also derive high value out of this seminar.

Article on FDA 21 CFR Part 11 Compliance

FDA-regulated industries electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these.

The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order to deem electronic signatures authentic. The electronic records, electronic signatures, and handwritten signatures executed to electronic records of several FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries have to be compliant with the standards set out in FDA 21 CFR Part 11 Compliance to prove that these are authentic, safe and trustworthy. The operative factor is that the FDA has to consider these signatures as being on par with those done on paper.

Which industries are included in FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 Compliance applies to nearly all FDA-regulated industries, including but not restricted to:

  • Medical device manufacturers
  • Drug makers
  • CROs
  • Biotech companies, and
  • Biologics developers

The Aim of FDA 21 CFR Part 11 Compliance

The aim of FDA 21 CFR Part 11 Compliance is to ensure that specified FDA-regulated industries such as those mentioned above (with specific exceptions) implement controls -which could include audits, audit trails, documentation, system validations, and electronic signatures -for software and systems involved in processing electronic data that are:

  • Required to be maintained by the FDA predicate rules or
  • Used to demonstrate compliance to a predicate rule. The FDA describes a predicate rule as any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. FDA 21 CFR Part 11 Compliance also applies to submissions made to the FDA in electronic format, such as a new drug application.

Which industries are exempt from FDA 21 CFR Part 11 Compliance?

Interestingly, exceptions are allowed within the same industry, based on the format of filing. For example, while FDA 21 CFR Part 11 Compliance applies to submissions made to the FDA in electronic format; it does not apply to a paper submission for the same made in electronic format, such as fax.

Also, FDA 21 CFR Part 11 compliance is not required for record retention for trace backs by food manufacturers. Similar to the logic used in the mode of filing as noted above; most food manufacturers are not otherwise explicitly required to keep detailed records, but when organizations keep electronic documentation for HACCP and similar requirements; this documentation must meet these requirements.

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Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket submissions that win regulatory approval challenging? It is the fact, acknowledged by the FDA itself, that the PMA is the most stringent type of device marketing application required by the FDA. The PMA should be secured from the FDA before the company markets the medical device. The FDA gives its approval of the PMA for a Class II medical device only after it determines that all the elements necessary for assuring that the application has enough scientific confirmation that it is safe and effective for the intended uses it is going to be put to. Preparing premarket submissions thus is an onerous task by any stretch of imagination.

Another element of preparing premarket submissions that win regulatory approval

Another aspect of preparing premarket submissions is the 510 (k). The 510 (k) is essentially a kind of premarket submission that is made to the FDA to show that the device that a manufacturer intends to market is at least as effective and safe as a legally marketed device of its equivalence, already in the market, that is not subject to PMA. The FDA calls this principle the substantial equivalency (SE) and the device that is used as the reference for equivalence, the predicate device. The requirements governing SE are contained in 21 CFR 807.92(a) (3).

On top of all these, regulatory professionals have the responsibility of creating preparing premarket submissions that should not only convincingly demonstrate the ways of stating and explaining regulatory arguments for their device to the U.S. FDA reviewer for getting the approval; they should also be presentable and well-organized, without being cluttered or confusing.

Professional trainings for preparing premarket submissions that win regulatory approval

Given all these, it goes without saying that a completely thorough understanding and knowledge of the relevant U.S. FDA laws, regulations and requirements is absolutely necessary for regulatory professionals. This in-depth understanding can be had only from thorough training, which is indispensable if the medical device company is to win a clearance or approval.

The ways by which to do this is the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will impart. The Director of this seminar is Subhash Patel, a very senior regulatory professional and founder of New Jersey-based MD Reg Consulting LLC, which serves medical device industry clients in all aspects of global regulatory affairs specific to their needs.

To enroll for this highly valuable training session on how to successfully prepare 510(k)/Pre-IDE/IDE and PMA premarket submissions that secure clearances and approvals from the FDA, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900776SEMINAR?wordpress-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.

The grasp needed for preparing premarket submission that win regulatory approval

At this seminar, Patel will demonstrate the grasp that regulatory professionals in the medical devices industry need for working with the FDA officials during the review and approval process of their submission. He will offer a complete understanding of the major aspects of FDA premarket submissions.

While knowledge of the regulatory process is one thing; medical device companies also need to know how to set and state regulatory arguments for their device in a most convincing manner to the FDA reviewer. This knowledge will be part of this course. In the process of explaining how to prepare premarket submissions that win regulatory approval; Patel will also offer tips and suggestions to participants on how to work effectively with the U.S. FDA officials during review and approval process of their submission.

During the course of these two days, Patel will cover the following core elements of how to prepare premarket submissions. He will explain the following:

o  History and background of U.S FDA Laws and Regulations

o  Classify Your Device

o  Choose the Correct Premarket Submission for your device

o  Compile the Appropriate Information for your Premarket Submission

o  Author and Prepare your Premarket Submission

o  Submit your Premarket Submission to the FDA

o  Interact with FDA Staff during Review and Approval

o  Complete the Establishment Registration and Device Listing

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm