Biocompatibility testing and evaluations for medical devices

Biocompatibility testing and evaluations for medical devices is a vital component of patient safety, for it is the only effective means to ensuring that a medical device or any related material, when it happens to come into contact with the patient’s body has to not only perform its intended purpose and function; it should also not result in adverse reactions for the patient.

When medical devices and/or materials come into contact with the patient’s body, they can cause problems or what may be termed adverse effects that can be either short-term or long-term adverse effects to the body. These effects, called acute to chronic, can result in mutagenic effects. It is to prevent the occurrence of such events that biocompatibility testing and evaluations for medical devices has to be carried out.

These evaluations for biocompatibility of medical devices are done to evaluate the interaction between a device and anything it comes into contact with within the patient’s body, such as cells, tissue or body fluids. Essentially, device biocompatibility is assessed to prevent biological risks from happening to the patient.

ISO standard for biocompatibility testing and evaluations for medical devices

The International Standards Organization (ISO) has a specific standard for carrying out and ensuring biocompatibility testing and evaluations for medical devices. It is called ISO 10993-1: 2009, and makes biological evaluation part of a structured biological evaluation program that comes under a risk management process. All these are carried out in accordance with ISO 14971.

ISO 10993-1, Biological Evaluation of Medical Devices – Part 1 The basis for biocompatibility testing and evaluations for medical devices is the Risk Management Process. This is the most prevalent standard for assessing biocompatibility testing and making evaluations for medical devices. In requiring biocompatibility testing and evaluations for medical devices to be conducted in compliance with Principles of Good Laboratory Practice (GLP) and/or ISO/IEC 17025 and requiring the consideration of evaluation of local and systemic risk factors; the ISO 10993-1 is considered the basis for determining the subsequent, necessary biocompatibility testing and evaluations for medical devices.

What factors are tested? In line with the principles set out in ISO 10993-1: 2009 on biocompatibility testing and evaluations for medical devices, specific testing is prescribed based on two factors: a) the type and the intended use of a medical device or related material, and b) the kind, tenure and extent of contact the medical device makes with the body.

ISO 10993-1: 2009 on biocompatibility testing and evaluations for medical devices requires assessment to be made for the following among others:

  • Cytotoxicity
  • Genotoxicity
  • Sub chronic toxicity
  • Sensitization
  • Irritation or intra-cutaneous reactivity
  • Implantation
  • Haemocompatibility
  • Systemic toxicity, etc.
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The vital area of Pharmaceutical Process Engineering

Pharmaceutical Process Engineering is an often-overlooked area in the field of pharmaceutical manufacturing. It calls for a high degree of precision and coordinates technical expertise and communication between professionals involved at diverse levels of the manufacturing unit, such as pharmaceutical researchers, chemical engineers and industrial. It is concerned with how pharmaceutical development is related to the application of major concepts and important unit operations in the field of pharmaceutical engineering.

Development and adaption of technology is one of the major bottlenecks of pharmaceutical process engineering. The major changes that digitization has brought into areas such as say, education and automobiles are yet to be fully realized in pharmaceutical process engineering. The benefits of digitization are yet to be felt and fully put into use in the crucial areas of pharmaceuticals, such as manufacturing -which, being a high precision area, offers tremendous scope for the use of conceptualizations such as the Internet of Things (IoT)- supply chain management, and Quality Control.

Lack of integration between the core functions and regulatory pressures are often cited as major reasons for which pharmaceutical process engineering is yet to catch up with the drastic changes wrought by technology.

Full understanding of the area of Pharmaceutical Process Engineering

A complete assessment of the present scenario in the pharmaceutical process engineering field, along with the its prospects for the future will be made at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. At this session, Co-founder and CEO of CGMP University Inc. Training and consulting organization and well-known author of several books relating to GMP; David Muchemu, will be the speaker.

Want to understand the importance and the prospects of this very vital area of pharmaceutical process engineering? Then, please register for this webinar by visiting Choosing process variables to control

Preventing flare-up of issues

David will help participants understand how to avoid being in situations where issues arise after scale up. The main reason this happens is that process variables and their parameters are never established based on hard data and engineering realities. David will offer a solution that combines engineering factors and scientific data collected in the lab into process control to counter such problems. He will explain the following major topics relating to these:

o  The process concept

o  Design of Experiment: DOE

o  Choosing process variables to control

o  Process validation

o  Process scale-up

o  Batch reactors

Of high value to professionals in pharmaceutical process engineering, such as Quality Engineers, Manufacturing Engineers and Line Managers; this webinar will cover the following areas:

o  Quality Risk Management Defined

o  Compliance Requirements for Quality Risk Management

o  The Quality Risk Management Model

o  Quality Risk Management Life Cycle.

Click here to continue for updates https://goo.gl/forms/RxxE6Azk3XUwXFku1

Who oversees the trial, has to undertake to the FDA

A vital document required when carrying out a clinical trial is FDA Form 1572 Statement of Investigator. It is a contract between the Principal Investigator (PI) and the FDA. FDA Form 1572, or just 1572, has all details of the subjects in the research, as well as the commitments the PI, who oversees the trial, has to undertake to the FDA. This commitment concerns meeting all the requirements from the FDA as they relate to the trial.

When the PI signs the FDA Form 1572, which relates to IND studies, or the “Statement of the Investigator, which is meant for IDE studies; she undertakes a commitment that she will comply with all the appropriate regulations and will be liable to facing legal action in the event of failing to do so. Hence, the FDA Form 1572 is a strongly legally binding document which sets out the terms of the commitment between the PI and the FDA.

The FDA has created the form 1572 with two main intentions:

It aids the FDA in gauging the PI’s suitability for overseeing the study, as it requires the latter to declare criteria related to this, such as experience and qualification. It also helps it understand the purpose of the study and the suitability of its methods to help it achieve its aims. Not only the FDA, but also the sponsor of the study can get this information from the form 1572.

Additionally, the FDA Form 1572, by taking an undertaking from the Principal Investigator that she will meet the requirements set out by the FDA during the trial; criminalizes the failure on the part of the PI to meet these conditions. It treats this as giving false statements, which empowers the agency to proceed legally against the PI under 18 USC 1001. When the sponsor selects the Principal Investigator to conduct a clinical trial as an investigational new drug (IND) that meets the criteria set out in 21 CFR 312.53 (c); this form has to be submitted.

Other documents accompanying the 1572

In addition, the following documents, which set out the general and specific responsibilities that the Investigators have when conducting a clinical trial; have to accompany the FDA Form 1572:

  • 21 CFR 312.50: contains the General Responsibilities of Investigators
  • 21 CFR 812.100: sets out the Responsibilities of Investigators for Biologics
  • 21 CFR 812.110: details the Responsibilities of Investigators for devices.

Get to understand the workings of FDA Form 1572

With the FDA Form 1572 being of crucial importance, compliance with it is not something that a sponsor or a PI can take lightly. Meeting the regulatory requirements set out in this document is in the interest of everyone concerned.

It is with the purpose of familiarizing the aspects relating to FDA Form 1572 that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing a webinar.

The speaker of this webinar, Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena, will offer insights into the nature of the due diligence that investigators and their staff have to take in meeting their regulatory and legal responsibilities.

Please register for this highly educative webinar by visiting Form FDA 1572 Seriously

FDA Form 1572 contains nine statements, seven out of which begin with “I agree”. Some of the essential elements named in the 1572 include:

  • 21 CFR 50 (Protection of Human Subjects)
  • 21 CFR 56 (Institutional Review Boards)
  • 21 CFR 312 (Investigational New Drug Application/IND)
  • For Device studies, 21 CFR 812 (Investigational Device Exemptions/IDE) is added in place of 21 CFR 312.

Also, additional responsibilities are outlined in GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811. In addition to complying with the principles of Good Clinical Practices (GCP); the PI and sponsors are advised to also use their discretion.

At this session, the speaker will offer complete clarity on these aspects. The following areas will be covered at this webinar:

  • The Investigators role in the clinical research process
  • The difference between AEs and SAEs and the reporting requirements of the investigator
  • Why the investigator maintains a list of staff signatures?
  • Why the investigator files the signed and dated protocol?
  • Why the investigator is responsible for the IC process?
  • What is the legal language of the FDA Form 1572 or Device equivalent?
  • Why is Financial Disclosure information important?
  • What is the history of the drug / device regulations?

For updates from this please https://goo.gl/forms/SNAcsW8rLKPrzxLD2

The AAMI TIR 45 is invaluable in helping adapt Agile methods for medical device software

A report from the Association for the Advancement of Medical Instrumentation, namely, AAMI TIR 45, offers recommendations for how to comply with both international standards and guidance documents from the FDA when it comes to Agile practices for developing medical device software.

The AAMI TIR 45 is an attempt to align and synchronize Agile’s values, goals, principles and practices to medical device software development. It shows the ways of doing this. It seeks to remove the many misconceptions and myths surrounding the suitability and adaptability of Agile to medical device software and explains how to apply Agile methods for meeting the Quality System requirements set out for medical device software.

AAMI TIR 45 has been set out to help manufacturers of medical device software reap the benefits that Agile provides, while staying compliant with the regulatory expectations and requirements.

The AAMI TIR 45 was created because of the value that Agile can bring to medical device software. One of the reasons for which Agile was developed was to address concerns relating to the quality and efficiency present in the methods of software development that existed then. When its core features are adapted to the medical device software field, it brings enormous benefits, some of which include:

–       It allows for continuous and persistent focus on risk management, safety and delivering customer value through its method of prioritizing backlog work, and practices relating to planning and customer feedback

–       It uses continuous integration and testing to continuously and consistently assess quality

–       Through its methods of retrospective action and accountability; Agile brings in continuous improvement into the process of software development

–       By focusing on getting things done one stage at a time and thus ensuring timely and incremental completion of work and deliverables; Agile satisfies the demands and needs of the medical device company’s stakeholders in the management and quality areas.

A few reservations

Many experts in both medical device software and Agile fields have expressed reservations about the suitability that Agile has in an extremely stringently regulated area such as medical device software. They refer to the Agile Manifesto, which seems to contain value statements that seemingly contradict the values at the core of a Quality Management System.

They also draw attention to the fact that as Agile evolved at a time when there was no criticality attached to risk management and human safety; the controls needed for producing software to which safety is critical have not been embedded into Agile.

Requires proper understanding and implementation

These points notwithstanding; Agile comes with a fundamental adaptability to the context it is applied in. Implementing Agile principles and practices in a proper way makes it more than adequate in an area like medical device software, where safety is critical. It is perfectly well-suited to accomplishing the lifecycle steps prescribed in IEC 62304 and risk management under ISO 14971. It can also help achieve usability design as required under IEC 62366

A learning session on the AAMI TIR 45

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer thorough clarity on the area of the suitability of the Agile to medical device software. The speaker at this session, Brian Shoemaker, will unravel the elements of AAMI TIR 45 and explain how it can be applied to medical device software smoothly and effectively in a manner that meets regulatory requirements.

Please visit Agile Meets Software Standards to register for this webinar and derive the benefit of understanding how to apply Agile principles to medical device software.

At this webinar, Brian will help understand how the AAMI TIR 45 can be the ideal roadmap for facilitating and bettering development, which benefits everyone concerned, be they development teams, companies, patients, caregivers, or regulators.

He will put this in perspective by explaining the following topics:

o  Convergence: Agile principles and regulatory needs

o  Lifecycle: incremental development, design reviews, documentation

o  Key practices: planning, collective effort, product definition

o  Implementation: evolving architecture, emergent design, continuous testing, traceability

o  Managing your software: release, configuration management, third-party software, and CAPA

Brian will cover the following areas at this webinar:

o  TIR 45 comes at a much-needed time

o  TIR 45 stitches together the important high-level concepts

o  TIR 45 outlines key practices that are needed for flexibility and quality

o  Implementation issues are not ignored

o  This TIR is actually just a starting point.

For more updates and articles AAMI TIR 45

Misinterpretation of closed Data when Treated with “Normal” Statistical Methods

Geology is among the many branches of science in which compositional data (CoDa) arise naturally. In branches such as geochemistry, compositional data seem to occur typically, when one normalizes raw data or when one obtains the output from a constrained estimation procedure, such as percentages, ppm, ppb, molar concentrations, etc.

Compositional or constrained data have proved difficult to handle statistically because of the awkward constraint that the components of each vector must sum to unity. The special property of compositional data (the fact that the determinations on each specimen sum to a constant) means that the variables involved in the study occur in constrained space defined by the simplex, a restricted part of real space.

It is important for geochemists and geologists in general to be aware of the fact that the usual multivariate statistical techniques are not applicable to compositional data. They need to have access to appropriate techniques as they emerge and become available.

Pearson was the first to point out dangers that may befall the analyst who attempts to interpret correlations between Ratios whose numerators and denominators contain common parts. More recently, Aitchison, Pawlowsky-Glahn, S. Thio, and other statisticians have developed the concept of Compositional Data Analysis, pointing out the dangers of misinterpretation of closed data when treated with “normal” statistical methods.

Learning about all elements of CoDa

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will throw light on all the important aspects of CoDa. At this session, Ricardo Valls, a professional geologist with thirty years in the mining industry, and who has extensive geological, geochemical, and mining experience, managerial skills, and a solid background in research techniques; will be the speaker.

To gain insights into CoDa, please enroll for this webinar by visiting  real case studies developedreal case studies developed

At this session, Ricardo will present several real case studies he has developed, to demonstrate the advantages of applying various aspects of the CoDa analysis in the search for and evaluation of ore bodies by comparing them with regular statistical modelling of geochemical data.

At this webinar, which will be of high value to personnel involved in mining, such as Geologists, Geochemists, Exploration Personnel, Graduate Students, and Post-Graduate Students; Ricardo will cover the following areas:

o  History of the Problem

o  The Current Situation

o  The Model

o  Normal Statistical Processing of the Data

o  Compositional Data Analysis

o  Factor and Principal Component Analysis

o  Dealing with zero and b.d.l. Values

Conclusions and Recommendations.

For more click the advantages of applying different aspects

Learn How to manage and improve Human reliability

Manufacturing is a behemoth of an activity that straddles several industries. Modern manufacturing has come a long way from the days of its infancy, which can be traced to the Industrial Revolution of some 250 years ago. Getting advanced and refined at many stages; production or industrialization or manufacturing is the lifeblood of most of the world’s economies. Automation in the processes may have been introduced in many industries; yet, manufacturing continues to depend heavily on human labor.

Although industrialization and manufacturing came about from the human intellect and endeavor; it is still prone to human error. It is a fact that wherever there is human involvement, there is scope for error. This is because we are humans after all. We can take the highest diligence in the work we do, but can make errors. On most occasions, these are unintended, but the result is negative. Errors in the manufacturing processes will continue so long as humans are involved in manufacturing to some or another degree.

Human errors can bring high costs

Manufacturing being an interlinked activity; human errors can cause many problems. One small error in the chain can affect the whole process, triggering a whole chain of errors. Although precise assessments cannot be made of the loss caused by human error; it is roughly estimated that the American and British pharma industries alone accrue losses of around $25 billion a year due to this factor.  Further, unexpected runtime error, which results in loss of more than a third of the productive time; is a direct consequence of human error. Human error can also lead to losses relating to quality and production. It is the cause of many performance issues.

It has to be understood that even with the knowledge of the consequences of human error, and with all the advancements and developments that have been made in high end, precise technologies and processes; the manufacturing sector is not likely to eliminate human errors. They can only be mitigated and minimized.

Getting to the root of the problem is important

Most manufacturers resort to a disjointed approach to human error. The positive approach to containing human error should be to locate its source. It is a fact that human error starts at the earliest stage, the design stage. Although this is known to many manufacturers and they are equally aware of the fact that training is a great tool to reduce human error; many in the manufacturing sector don’t take training seriously.

Along with training, other factors such as controlling the procedures and the workplace environment, where the various variables that affect human behavior converge, need to be taken into consideration. The manufacturer should directly address the systemic weaknesses to improve or fix them. An understanding of human behavior and the psychology of error is necessary to do this. Getting to the root of human error involves these among others:

 

o  Implementing human factors in manufacturing

o  Communicating in the right manner

o  Fostering continuous practice

o  Imparting the proper methods of training

o  Offering a thorough description of the right procedures with the right instructions

o  Bringing about a positive work environment

o  Putting the right processes in place.

A training session on understanding human error

Ginette Collazo, a human error and human behavior expert who has spent more than 15 years in technical training, organizational development and human reliability areas, will be the speaker at a webinar on human error that Compliance4All, a highly acclaimed provider of professional trainings for all the areas of regulatory compliance, is organizing.

Please enroll for this webinar by visiting Human Error Reduction

Practical approaches to all areas of human error

Ginette will offer a complete understanding of the nature of human error, its roots, and its psychology. This webinar seeks to help regulatory and quality professionals get a thorough idea of the factors that cause human error. In order to facilitate proper understanding of this topic, the speaker will offer practical approaches and tools to address human performance issues in manufacturing. The understanding of the human psychology and behavior behind human errors that she will offer will give insights to where the weaknesses lie. This in turn will help to address the human performance issues and help correct and prevent recurrences of human error.

The following areas will be covered at this webinar:

  • Background on Human Error Phenomena and measurement
  • Importance of Human Error Prevention/reduction
  • Quantitative and qualitative information gathering
  • Why do we need tools for human error reduction programs?
  • Training as a tool and human error
  • Facts about human error and training
  • Human Error as the Root Cause: what to do and how to measure it
  • Tools
  • Prediction
  • Root Cause Analysis
  • Cognitive load assessment
  • Systems available
  • Human error rate
  • Floor checklist
  • Interview questions
  • Human error rates and other metrics
  • Trending and tracking
  • CAPA effectiveness
  • Metrics and Human Error
  • KPI’s
  • Human Error rate
  • 1st time pass rate
  • Overall equipment effectiveness (OEE)
  • Trending /Tracking

For updates click the below Link Human error rates and other metrics

Learn How to Prevent Quality and Compliance Problems by having a strong system for Purchasing Controls!

In this era of globalization; outsourcing has become a major component of business. Outsourcing brings many benefits for companies. Short and long-term cost benefits, the ability to concentrate on their core activities and grow their business, and the freedom of avoiding the actual tasks that go into manufacturing are some of the stated benefits of outsourcing.

When it comes to high precision, high technology and critical products such as medical devices, outsourcing brings many benefits, but comes with enormous challenges. Because of the nature of the products, and the intended use they are put to; medical devices need proper controls when they are being entrusted to suppliers. Controls are a dire need for any product, but more so for such lifesaving products as medical devices.

Disastrous consequences of lack of proper controls

Failed products or components can have disastrous consequences on the patients, who are the end-users of these medical devices. Avoiding such situations is in the interest of everyone concerned, be it the patient or the manufacturer. While the adverse effects of the use of defective medical devices on the patients are known; medical device manufacturers too, stand to suffer when such products enter the market. They suffer a loss of reputation. Their products could get recalled, and the FDA could slap 483’s or Warning Letters, or impose other harsh penalties on them.

Most important of all, the FDA holds the manufacturer and not the supplier responsible for any such mishap. Therefore, the need for putting supplier controls in place is critical. They must comply with the standards and requirements for this aspect set out by the FDA, namely CFR 820.50.

If manufacturers choose to manufacture their products themselves, the onus is equally high, because in this instance, they must put the right purchasing controls in place. Purchase starts with the selection of the raw material for the product and could potentially include the purchase of all components, each of which should comply with the standards specified by the FDA.

A complete understanding on how to put effective purchasing/supplier controls in place

A detailed learning session which will offer proper understanding of the controls that need to be put in place for purchasing/supply of medical devices is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, and who brings an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities; will be the speaker at this webinar.

Please visit 483 and Warning Letter citations to enroll for this webinar and gain complete understanding of the controls that need to be put in place for purchasing/supplier of medical devices.

Susanne will give the participants of this webinar an understanding of their responsibilities in terms of purchasing controls, which will enable them to provide safe and effective products to your customers. She will show how to prevent quality and compliance problems by putting a strong system in place for purchasing controls.

She will familiarize participants with the regulations and how they can translate these into an efficient and effective process for purchasing/ supplier control. The essential elements of purchasing control and how these can be translated into their procedures will explained. Susanne will also discuss the process steps for purchasing control and how it relates to other parts of a manufacturer’s QMS including receiving and acceptance activities.

She will cover the following areas at this webinar:

  • Understanding the regulations
  • Lessons Learned
  • FDA Expectations
  • Purchasing Controls Process
  • Planning
  • Evaluation of Suppliers
  • Purchasing Data
  • Performance Management
  • Feedback and Communication
  • Best Practices
  • Inspection Readiness

This session will help personnel in the medical devices industry who are connected with supplier and purchase, such as Supplier Engineers, Supplier Auditors, Supplier/Purchasing Managers, Quality Engineers, Supplier Quality Engineers, Compliance Personnel, and Compliance Specialists.

For more updates just click the below link controls for medical devices