Right now Medical device hazard analysis, the core of medical devices

Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.

So, what is medical device hazard analysis? Medical device hazard analysis may be defined as a structured method of analyzing the inherent and potential problems that a medical device could have at any stage of its production or after it is released into the market.

The need for medical device hazard analysis

Medical device hazard analysis has to be done for a number of reasons. It is required by the FDA as part of a product development Design Control Program. The FDA recommends ISO 14971 as the standard for medical device hazard analysis. This is because the ISO 14971 hazard analysis standard is considered the most comprehensive of all medical device hazard analysis tools.

What makes this so is that the ISO 14971 takes risk into consideration in normal state, as opposed to other tools such as Fault Tree Analysis (FTA) and Failure Modes and Effects Analysis (FMEA), which only consider fault conditions. The latter two, in relation to the ISO 14971 standard, are more suitable for as tools for reliability rather than as those for product safety.

However, despite the uses it has; medical device hazard analysis in relation to ISO 14971 is considered quite complex because of the free and broad implication of a few important terms, even if they are pretty straightforward in terms of their definitions. Some of the words that cause confusion over their interpretation when they are being put to practical use include:

Hazard: Generally described as the potential site or basis of harm

Hazardous situation: A circumstance or situation which exposes people to a hazardous event or environment

Harm: Any degree of physical damage or injury from the medical device to the people working with it, or to the property or to the environment

Causative event: An event that may be said to be the source or cause of an adverse event in a medical device

ALARP: As Low as Reasonably Practicable, or judging how to weigh a risk against its benefits. This involves having to take a tricky decision in many situations

Risk index: A risk index is about assigning a score that will help determine the course of action when the risk index falls within categories

Residual risk: The level or extent of risk that remains after all the measures for risk control have been implemented.

There is more to medical device hazard analysis than these

The fact of having to take all these plus other factors into consideration for medical device hazard analysis makes it a challenging matter, because medical device hazard analysis should be done in such a manner that nothing is left to chance.

Want to understand the intricacies of medical device hazard analysis? Then, enroll for a highly relevant and absorbing session on medical device hazard analysis. This webinar is being organized by Compliance4All, a highly recognized provider of professional trainings for all the areas of regulatory compliance. Just log on to http://www.compliance4all.com/control/w_product/~product_id=501207?Wordpress-SEO to register.

Clearing the confusion about terms in medical device hazard analysis

At this session, Edwin Waldbusser, who has been consulting in the US and internationally in the areas of design control, risk analysis and software validation, will be the speaker. He will throw light on all the confusing terms listed above. He will offer clarity on how to prepare a thorough medical device hazard analysis that will help those participating into this learning session.

Edwin will go step by step through a template for hazard analysis to help clear the confusion about the meaning of these terms and make the process clear. He will discuss examples of hazards and hazardous situations and explain how to deal with residual risk. He will walk participants step by step through a typical medical device hazard analysis.

Also explained in this session on medical device hazard analysis is the way of integrating Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program.

In the course of this lively discussion on medical device hazard analysis, Edwin will cover the following areas:

o  Explanation of Hazard Analysis terms

o  Hazard analysis process explanation using a template

o  Examples of terms will be given

o  Hazard analysis examples will be covered step by step.

http://blog.greenlight.guru/iso-14971-medical-device-risk-management

http://www.fda-consultant.com/risk1.pdf

http://nuhrise.org/wp-content/uploads/SOP-52-Adverse-event-reporting-for-medical-device-trials-SOP-NUH-sponsor-version-1.pdf

http://www.hse.gov.uk/risk/theory/alarpglance.htm

Today’s Pre control and Statistical Process Control (SPC)

Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.

SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that carrying changes out is neither practicable nor useful.

Examples of process changes that SPC helps to detect include trends, shifts and variation. Three items are needed for SPC to meet its goal:

o  A system that measures effectiveness in real-time

o  Tolerance that is practical and is connected to customer keenness and satisfaction

o  A dial indicator that comes with an anticipated response.

All these help SPC to determine whether a process is stable and requires no adjustment, is incapable of performing its functions altogether, or is deviating but capable.

And now, pre-control

Pre-control, on the other hand, inspects the units and adjusts the process and the succeeding sampling procedures assuming where the measurements are placed in relation to the specification limits. The focus of pre-control is individual measurements.

It uses a set of probabilities, based on assumed distributions and the location of the process, to estimate where there is a justification for the process adjustments. Since decisions concerning pre-control are based broadly, i.e., on the area in which the measurements; it obviates the need for charting, as it is very responsive to the process signals right from the start.

SPC or pre-control?

There are arguments for and against the use of SPC and pre-control as an effective means of ensuring that the process is right and that it results in the desired quality for the product.

At a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, the speaker, Jd Marhevko, who has been involved in Operations and Quality/Lean/Six Sigma efforts across a variety of industries for more than 25 years, will explain all the aspects of pre-control. To hear her perspective of pre-control, please register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501074?Linkedin-SEO

What makes this webinar special is that it has consistently ranked in the top 1-5% at previous conferences at more than five venues. It was featured in ASQ QMD’s special edition of the Quality Management Forum’s 2015 Spring edition (ASQ-QM.org). A webinar of this topic was provided in 2015 via the ASQ QMD Linkage Technical Committee to over 1300 respondents through the IMA and ASQ QMD.

Tools needed for pre-control

At this hour-long session, Jd will explain all the elements of pre-control in Quality. she will show to participants the way of drafting and creating a pre-control chart. She will run a process in which to model the next steps and decisions.

The aim of this session is to equip participants with the knowledge needed for reducing the complexity of the system and bringing about an improvement in the effectiveness and efficiency of their Quality Management Systems.

A session packed with interaction and practical application of principles

A major component of this webinar on SPC and pre-control is that Jd will share the result of case studies. The knowledge gained at this webinar can be applied immediately at their work in respect to the following:

–       Measurement System Analysis (MSA): Jd will conduct a high level overview of MSA. This will help the participants get a grasp of the need for putting an effective measuring system in place ahead of implementing pre-control

–       Cpk Overview: To help participants gain baseline capability in advance of implementation of pre-control, a high level Cpk overview will be conducted

–       Normal Distribution: The way in which the cumulative distribution function of the normal distribution is to be used for estimating and establishing the zones on a pre-control chart

–       Pre-Control Chart: Jd will show participants how to apply the concepts listed above with the use of a mock pre-control chart where the process will be demonstrated based on the “go/no go” zones that are established.

At this webinar, Jd will cover the following areas of pre-control:

o  Reduce process complexity and minimize risk

o  Increase affectivity of a Core Tool

o  Increase personnel compliance in proactive process management.

https://www.isixsigma.com/tools-templates/control-charts/using-control-charts-or-pre-control-charts/

http://www.symphonytech.com/articles/pdfs/precontrol.pdf

http://www.winspc.com/what-is-spc/ask-the-expert/400-pre-control-no-substitute-for-statistical-process-control

http://www.qualitymag.com/articles/86794-pre-control-may-be-the-solution

International Financial Reporting Standards (IFRS) 6

The International Financial Reporting Standards (IFRS) standards are a set of standards pertaining to different industries and their activities and practices. IFRS 6 relates to guidance in the accounting practices of the extractive industries, such as oil, mining and gas. The IFRS 6 accounting standard states the requirements, as well as the disclosures that need to go into accounting practices for expenses that a company incurs during the course of exploring and evaluating expenditures.

Till the enactment of the IFRS 6, regulations on the accounting practices of the extractive industries were fragmented and piecemeal. The major change the IFRS 6 brought about it is that it consolidated these practices. Also, with the passage of IFRS 6, entities that were using accounting practices for exploration and evaluation assets that were in use prior to the enactment of the IFRS 6 could integrate these earlier practices with the provisions of the IFRS 6.

Core accounting requirements

One of its core requirements is that of the issuance of IFRS compliant financial statements by companies that have assets used for exploration and evaluation of mineral resources.

So, it is imperative for accounting professionals to have full knowledge of the IFRS 6. Working with the oil, mining or gas areas in companies that have assets that are used for exploration and valuation of mineral resources and being successful entails having to comply with the requirements set out by the IFRS 6.

A proper understanding of the IFRS 6

A learning session that is being organized by Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will offer the learning needed for getting trained on how to comply with the requirements set out in IFRS 6.

At this webinar, Mike Morley A Certified Public Accountant and business author who organizes various training programs, such as IFRS, SOX, and Financial Statement Analysis that focus on providing continuing education opportunities for finance and accounting professionals, will be the speaker.

Professionals who work in the oil, mining or gas areas in companies that have assets that are used for exploration and valuation of mineral resources can gain insights into what the IFRS 6 means for them by enrolling for this webinar. To register, please visit

http://www.compliance4all.com/control/w_product/~product_id=501194?Wordpress-SEO

Familiarization with all the aspects of the IFRS 6

The aim of this presentation is to help oil; mining and gas professionals become knowledgeable about the latest information about IFRS 6. The speaker will familiarize participants with the unique accounting and reporting issues, particularly in regards to the evaluation of assets, revenues and expenditures that professionals in the extractive industries, involved in the search for mineral resources, including oil, gas, minerals, and similar exhaustible resources face.

Accounting professionals who work in these industries, and who need in-depth understanding of the way the IFRS 6 is structured, and the ways in which they need to apply the standards in the right manner, such as Auditors, Accountants, Financial Managers, Financial Controllers, Company Executives, and anyone involved in the SOX compliance process, will benefit immensely from this webinar on the accounting practices set out by IFRS 6.

At this session on the IFRS 6, the speaker will cover the following areas:

o  Why the accounting for this sector is different

o  How resource assets are evaluated

o  Special rules for measuring revenues and expenditures

o  How revaluation rules apply to the Oil, Gas, and Mining industries

o  Other specific requirements of IFRS 6

o  Required disclosures.

http://www.accaglobal.com/in/en/student/exam-support-resources/dipifr-study-resources/technical-articles/ifrs6.html

http://www.icaew.com/en/library/subject-gateways/accounting-standards/ifrs/ifrs-6

https://www.iasplus.com/en/standards/ifrs/ifrs6

How do laboratories deal with Out of Specification (OOS) results?

Laboratory testing is the soul of the successful operation by a drug maker. It is required as part of current Good Manufacturing Practices (cGMP) regulations to confirm that all the elements that go into a laboratory product, namely raw materials; in-process materials, finished materials, and containers conform to set specifications. When a laboratory test throws up an Out of Specification (OOS), how do laboratories deal with it?

The FDA takes a very serious view of Out of Specification results

The FDA is very stern in dealing with laboratories which come up with Out of Specification results. It inspects laboratory operations very closely, and has clear guidance on how the laboratory investigates Out of Specification and Out-of-Tolerance observation investigations.

cGMP regulation Sec 211.165 specifies that finished Out of Specification products which fail to conform to set specifications, safety standards and other quality standards will be rejected. These cGMP regulations also state that any unexplained deviation from the set specifications of a batch or its contents will be thoroughly investigated if its test results show an Out of Specification result. This is the same rule for both batches that have been distributed into the market, and those that are not.

Steps to deal with Out of Specification results

cGMP regulation makes Out of Specification testing compulsory for the release of a test batch. Whenever an Out of Specification result is confirmed, the batch gets rejected, and if there is ambiguity in the result, then the company’s Quality Assurance (QA) will have to state the reasons for the release and justify it.

Section 501(a) 2 (b) of cGMP guidelines on Out of Specification requires that current Good Manufacturing Practices need to go into the manufacture of both active pharmaceutical ingredient and finished pharmaceuticals. Further, active pharmaceutical ingredients, raw material testing, in-process and stability testing and Process Validation all come under the purview of the cGMP guidelines.

The FDA guidance on Out of Specification covers the following products:

o  Human drugs

o  Biology and biotechnological products

o  Combination products

o  Veterinary drugs

o  Type A medicated articles

o  Transplantation of human tissues

o  Medicated feed

o  Finished products & active pharmaceutical ingredients

o  Dietary supplements

Need for understanding Out of Specification

All the complexity and depth of the issues relating to Out of Specification results need to be fully understood if a laboratory has to meet the required results. Important personnel in laboratories should have complete knowledge of the FDA expectations for Out of Specification results.

They have to use this knowledge to put in place procedures that define a complete, scientifically sound investigation of each Out of Specification and Out-of-Trend laboratory observation and to establish evidence that laboratory personnel are following the procedures.

A complete understanding of Out of Specification results and dealing with them

This will be the content of a training session that is being organized by Compliance4All, a highly popular provider of cost-effective professional trainings for all the areas of regulatory compliance.

At this session, Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker. To understand the concept and workings of Out of Specification results and the ways of dealing with them, register for this webinar by logging on to  http://www.compliance4all.com/control/w_product/~product_id=501214?Wordpress-SEO

Tools that help deal with Out of Specification results

At this webinar, Jerry will help participants build the foundation for the implementation of adequate procedures that help avoid Out of Specification results, and will review existing procedures and practices. This webinar is aimed at helping participants develop an understanding of the steps a compliant laboratory needs to take to handle the investigation of Out of Specification test results.

Jerry will also explain the ways in which the laboratory has to interface with other units through the laboratory investigation process. The FDA guidance on handling OOS laboratory results will be the foundation for this webinar, which will offer a clear process for compliant laboratory Out of Specification investigations.

Jerry will cover the following areas at this webinar:

o  Why the regulators are concerned about the handling of OOS investigations

o  The FDA model for handling OOS investigations

o  Commonly accepted terminology such as repeat testing and retesting

o  How the laboratory can meet regulatory expectations for OOS investigations.

o  The interaction between the laboratory and other units in the organization.

http://www.fda.gov/downloads/drugs/guidances/ucm070287.pdf

http://sphinxsai.com/2013/JulySept13/phPDF/PT=11(943-948)JS13.pdf

FDA Regulation of Combination Products is important to understand

FDA regulation of combination products is a very important aspect to keep in mind for pharmaceutical manufacturers. This is because of the complex nature of combination products. The definition for combination products is set out in 21 CFR 3.2 (e). Combination products assume importance in the industry because they combine two more drugs from different categories. This is what makes them unique. If a product is made out of two or more drugs from the same category, it does not qualify as a combination product.

Complex procedures which often involve specialized areas such as tissue engineering and biomedical nanotechnology go into combination products. This is why FDA regulation of combination products is very critical. FDA regulation of combination products is important also because these regulations are applied to areas that extend beyond just drugs. Combination products are manufactured in the areas of food, cosmetics and nutraceuticals.

Assigning a combination product to an Agency Center or another organizational component that has primary jurisdiction for its premarket review and regulation is set out under section 503(g) (1) of the FD and C Act. The criterion for this assignment is the determination of the “primary mode of action” (PMOA) of the combination product.

New field of combination diagnostics

FDA regulation of combination products has been gaining increased attention of late because of the emergence of the exciting and promising new field of combination diagnostics. In a nutshell, this area concerns the use of the combination of a drug with an in-vitro diagnostic (IVD). This area signals a big shift from existing methods because it helps a physician or any other medical professional to gauge the effectiveness of a drug before it is given to the patient. Prior to the rise of this field, the effectiveness of a drug could be ascertained only after the patient was given it.

All these facts promise a bright future for the area of combination products, but also highlight the role of FDA regulation of combination products. Any new, or for that matter, existing area of work or methodology or technology has to be regulated by the regulatory bodies around the world.

A webinar on the FDA regulation of combination products

An in-depth discussion of the FDA regulation of combination products 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. Thomas E. Colonna, who provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics and holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia, will be the speaker at this webinar. To gain a thorough understanding of FDA regulation of combination products, please visit http://www.compliance4all.com/control/w_product/~product_id=501096LIVE/~sel=LIVE/~Thomas_E.%20Colonna/~FDA_Regulation_of_Combination_Products to enroll.

In this session on FDA regulation of combination products, Thomas will cover the following important areas relating to the topic:

o  Definition of combination product

o  FDA Regulatory Pathways

o  Primary Mode of Action

o  User Fees

Post market surveillance needs to be robust to avoid penal regulatory action

Post market surveillance (PMS) is a very important activity for manufacturers of medical devices. It needs utmost care in handling, because the FDA considers post market surveillance as one of its primary means for protecting public health.

Post market surveillance is, in simple terms, the monitoring of the performance and quality of a medical device after it has been released into the market. Although this is a very long phase which lasts till as long as the patient uses the product or it gets recalled; post market surveillance is necessary because a problem can arise at just about any stage of the product’s life.

Post market surveillance is built on many well-established principles of safety

Being a well-established discipline, post market surveillance is built on many well-established principles of safety. Some of the foundations on which the principles of post market surveillance are built are:

o  Unique device identifiers (UDI)

o  Electronic health records

o  Medical device reporting

o  Device registries, and

o  Advance methods for evidence generation and data analysis

Despite the application of such concepts as mentioned above; post market surveillance is a discipline that is still evolving. So, given the primacy of its role in being a tool for protection of public health; those in charge of post market surveillance in medical device manufacturing companies need to be aware of what it takes to develop the capabilities for putting a foolproof post market surveillance system in place.

A learning session on how to get PMS right

The ways of doing this will be the content of a meaningful webinar that is being organized by Compliance4All, a leading provider of profession trainings for all 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.

To derive the benefit of Susanne’s rich experience with medical devices and to understand how to develop a program for solid post market surveillance, just visit http://www.compliance4all.com/control/w_product/~product_id=501156LIVE/~sel=LIVE/~Susanne_Manz/~Spotlight_on_Post_Market_Surveillance

Susanne will give an understanding to participants of the importance of ensuring product safety and its attendant patient safety at this session. She will analyze the fundamentals of this discipline and show how a medical device company can develop one of its own and develop the capabilities for a sound post market surveillance program.

This webinar will help participants build a PMS that will help arm them with the means of acquiring important information about the medical device, which will help reduce the adverse events.

Susanne will cover the following areas relating to PMS at this webinar:

o  Overview and Definitions

o  FDA Expectations, Regulations

o  Lessons Learned and Enforcement Case Studies

o  Medical Device Reporting

o  Investigating a complaint or MDR

o  FAERS–FDA Adverse Event Reporting System

o  Common Mistakes and how to avoid them

o  Preparing for an FDA or NB Inspection

o  Best Practices.

It is necessary to understand the nature of the differences between GMP and GLP

Differences between GMP and GLP are important to understand for professionals who work in areas which involve these two different, yet related practices. Since the two appear somewhat similar in terms of their application and nomenclature; there is considerable scope for misunderstanding and confusion.

It is necessary to understand the nature of the differences between GMP and GLP because those who are involved in these two practices have different roles to perform in the course of their work.

 

Differences between GMP and GLP are pronounced in laboratory testing

The differences between GMP and GLP are pronounced in laboratory testing, in which they serve different purposes.

This is how one can understand the differences between GMP and GLP: While GLP is concerned with preclinical development; GMP is related to manufacturing. In other words, GLP is based on study, while GMP is based on process.

Another area of understanding the differences between GMP and GLP is that the chief purpose behind designing GMP is to show to the regulatory bodies such as the FDA or the EPA whether or not individual lots or batches of any regulated manufactured product have met the criteria for manufacturing set out by these agencies.

On the other hand, the core purpose of GLPs is the protection of the integrity of scientific data. They are meant to provide regulatory agencies with data that helps the agencies scrutinize and audit the scientific validity of research studies.

Not so clear-cut in the areas of validation

However, the differences between GMP and GLP are not so clear-cut in the area of the application of validation. There is some lack of clarity on which areas of validation studies should be done under GLP and which, under GMP. When it comes to this area, it all depends on what is being validated. This factor dictates whether it is a GMP or a GLP is to be applied, based on what the professional considers appropriate for the occasion.

GMP precedes GLP

The fact that GMP precedes GLP is a commonsensical way of understanding the differences between GMP and GLP. Generally, GMP governs the earlier stage of testing. The testing of release lots and the proof of their conformity to standards set out by the regulatory bodies are done by GMP.

The next stage of this process, namely the testing of these products’ safety and efficacy, is done as part of GLP. This is another aspect at which the differences between GMP and GLP can be highlighted.

 

 

 

A learning session

Compliance4All, a leading provider of professional trainings for areas of regulatory compliance, will be organizing a webinar, at which the differences between GLP and GMP will be explained. Joy McElroy, a senior professional in the pharmaceutical industry, will be the speaker at this learning session.

To enroll for this webinar, just visit http://www.compliance4all.com/control/w_product/~product_id=501116LIVE/~sel=LIVE/~Joy_McElroy/~GLPs:_How_are_they_Associated_with_GMPs_and_SOPs

At this webinar, while explaining the difference between GLPs and GMPs and how they are associated with SOPs; Joy will cover the following areas:

o  What are Good Laboratory Practices

o  Why were they created

o  What is the objective of GLPs and how are they associated with GMPs and SOPs

o  Statistical Procedures for data Evaluation

o  Instrumentation Validation

o  Analytical and laboratory Certification

o  Documentation and Maintenance of Records

o  Consequences of Noncompliance

o  Disqualification and Reinstatement