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

Lyophilization: Validation and regulatory approaches

Lyophilization and its validation and regulatory approaches form an important aspect of parenteral drugs.

Lyophilization is a process in which a product is frozen and placed in a vacuum and water is removed from it. This removes the need for the liquid stage in the change of ice from solid to vapor. This process consists of three phases: primary, sublimation and desorption.

Lyophilization is considered complex

Parenteral products such as anti-infective drugs, many biotechnological products and in-vitro diagnostic products are some of the areas in which lyophilization is used. However, no matter for which field lyophilization is used, it is considered rather tough.

This is mainly because the process of obtaining the product from the lyophilization process is rather complex. It has to be carried out through a number of minute and delicate processes. Complex technology goes into the entire process.

Solution formulation, filling up vials and the validation of this process, sterilization, engineering, and the act of scaling up of the lyophilization cycle and its validation are some of the issues that make lyophilization difficult. Moreover, the processing and handling time needed for lyophilization is pretty high, as is the cost and complexity of the machinery and equipment needed for lyophilization.

Regulatory issues as well

On top of all these, the process of lyophilization has to be compliant with FDA compliance requirements. This adds to the complexity of lyophilization. However, despite these difficulties associated in many ways, lyophilization is a process that cannot be done away with, since it has tangible benefits for parenteral products.

Is there a way out of this difficulty? Should the complexity associated with lyophilization put manufacturers off? No. A webinar from Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will suggest ways of simplifying lyophilization while meeting the required regulatory expectations.

Simplified learning about the complex art of lyophilization

At this webinar, the speaker, John Godshalk, will seek to simplify the science of lyophilization. Currently a Senior Consultant at the Biologics Consulting Group; John brings the many years of his experience in the regulatory areas into this webinar. To make lyophilization simpler and to derive the benefit of this teaching, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501111?Wordpress-SEO

Understanding the FDA’s line of thinking

At this session on lyophilization, which will be highly useful for professionals such as Compliance Managers, Process Engineers, Validation Managers, Validation Engineers and Regulatory Managers; John will explain the way the FDA thinks when it comes to inspection and regulation of the lyophilization process, equipment, and controls.

The speaker will offer insights into what the FDA and other regulatory bodies consider as important while inspecting lyophilizers, and in the validation process. He will devote a major portion of the presentation to the regulatory aspects of lyophilization.

While explaining the science and art of developing lyophilization cycles and the way in which lyophilizers work and are controlled; John will take up other important areas of lyophilization, such as lyophilization controls, of which computer controls and validation are a part, and quality-related aspects of lyophilization, such as how to obtain a resulting quality product.

During the course of the presentation, the speaker will cover the following areas:

o  Science of Lyophilization

o  Cycle development and tools

o  Validation of the Lyo Cycle

o  Lyo equipment validation

o  Regulatory requirements

o  How the lyo process and equipment are inspected

o  The science and the art

https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074909.htm

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

Tightening carrier food safety issues can save costs for the food and logistics industries

The fact that between five and eight percent of current recall and shipment rejection issues happen within the cold chain food transportation sector, resulting in fairly high, but preventable financial loss is an indication of how much scope is there to contain seepage in the food and transportation industries.

Is this happening because of lack of regulation? No. Rather, it is the lack of proper understanding of these regulations that is at the root of the problem relating to food pilferage. There is no dearth of laws. For instance, there are the Food Safety Modernization Act and the Rules on the Sanitary Transportation of Human and Animal Foods.

In addition, for reference, there is also the “guidance” which the FDA previously published, which now has the power of law, being legally enforceable by many government agencies. Complying with these guidances and laws is the way forward for the food and transportation industries. All that is needed is to change mindsets, practices and operations. Inculcating this takes time, and comes about with proper professional training.

Ways of implementing the guidances and rules

This is what Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be imparting at a webinar. John Ryan, a Quality Systems professional who has worked for over three decades in a variety of industries globally and owns Ryan Systems, will be the speaker at this webinar. To enroll for this webinar, please visit http://www.compliance4all.com/control/w_product/~product_id=500995

This FDA recommended carrier food safety training course will highlight the problems that may take place in the process of food transportation. John will teach how to implement sound sanitation, temperature monitoring and quality controls, which can go a long way in preventing adulteration during loading, unloading and in-transit operations.

Plenty to learn from

This course will benefit professionals across the food and food transportation industries, such as Directors and Managers in Food Safety and Quality Personnel, food safety audit teams, perishables logistics personnel, compliance officers, food company CEO’s, drivers of food carrying trucks, and food load and unload personnel in a number of ways and help them save avoidable expenses by implementing checks and controls along the food transportation chain.

The following areas will be covered at this webinar:

o  FDA Sanitary and Temperature Controlled FSMA Rules

o  Definitions: Carrier, Container, Tools and Equipment

o  Preventive Controls Subpart G: Receiver Liability for Carrier nonconformance

o  Prevention versus Corrective Action

o  ATP

o  GAP Analysis

o  Pallet versus Case versus Container Temperatures

o  Temperature Measurement Technologies

o  Pallet Types

o  Sanitation Testing

o  Costs

Managing healthcare projects with ease and simplicity

Those in the healthcare sector go about their work like they are completing a project. Their work is made up of many parts, all of which they need to approach using many processes and plans. In keeping a tight watch on the budget and the deadline; many aspects of the work get overlooked, as a result of which the outcome suffers.

Each team member has a specific and important task in healthcare. All these have to be done with precision and in close synchrony with the work of other members of the team. Getting this harmonious coordination right is at the root of putting in place a systematic process that helps to get work done smoothly and in an organized manner in the healthcare sector.

Learn ways by which to work like in a project

How does a healthcare organization get this? What role does each member of a healthcare organization play in bringing this whole project process right in order to guide the future of the healthcare system? This is the learning from a highly interesting webinar that Compliance4All, a leading provider of professional trainings for all areas of regulatory compliance, will be organizing.

Cathy Dolan-Schweitzer, who is president of Health Well Done and has developed a 3-step integrated approach to managing healthcare projects; will be the speaker at this webinar. Please log on to http://www.compliance4all.com/control/w_product/~product_id=501005LIVE/ to enroll for this webinar.

Interpolating construction language into healthcare

The learning gained at this webinar will help the participants discover construction language, which is a strategy to reading plans. Cathy will help them experience the value of translating that into common language, so that the team shares and translates this wisdom and experience, usually applied in design and construction, to the medical professional. This experience, of course, is most important to the patient.

Nursing and clinical staff play a critical role in the hospital future improving quality in the built environment, designing spaces to influence the HCAP scores and engaging patient and staff advisory boards. Understanding design and construction language, plans and member roles when working on a project team can be challenging, but the speaker will help a simple three step approach that will make this easy. This approach will include using common language and tools to getting a patient centered healthcare project done. Using these techniques, the team can limit mistakes and reduce waste, while saving time and money.

Getting their documentation right is very important for medical device manufacturers

Documentation is at the heart of medical devices. If a medical device manufacturer cannot convincingly establish documentation of the manufacturing process; the medical device is bound to have regulatory approval hurdles. Every medical device manufacturer has to both establish and maintain all of these: documents, procedures and records, all of which must be under a state of control.

So, what should the documentation establish and prove? Documentation should show that manufacturers followed the prescribed scientific methods and procedures while manufacturing the devices. Only records of all these processes are accepted as proof that all these were followed by the manufacturers. This means that manufacturers need to keep in place several records of varying types, which need to be corrected from time to time with every new step or a revision, and importantly, make these easily available to the designated/authorized personnel.

How do manufacturers get their documentation right?

Given the importance of documentation –the FDA can impose heavy penalties to medical device manufacturers who cannot show the authenticity and integrity of their documentation as well as the recordkeeping methods pertaining to it –it is necessary for manufacturers to be thorough with their methodology. This requires professional training, because this is not something that manufacturers can take chances with.

It is to equip medical device manufacturers with all the elements of documentation and recordkeeping of their medical devices that Compliance4All, a highly popular provider of professional trainings on all areas of regulatory compliance, will organize a webinar. This webinar will be imparted under the expert guidance of Susanne Manz, an accomplished leader in the medical device industry, who emphasizes quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. More details of this webinar can be had from http://www.compliance4all.com/control/w_product/~product_id=500918LIVE

Ways of ensuring documentation to meet regulatory requirements:

This webinar will be highly useful for personnel in the medical devices industry, for whom the proper method of documentation is critical. Susanne will show what procedures and methods personnel in the many tiers of the medical devices industry need to follow in order to be able to maintain records that are well documented to meet regulatory requirements and how to keep these in the right place for easy access and correction.

She will show how medical device manufacturers can present these records in a timely and neatly organized fashion to the regulatory authorities during inspections, along with ways by which the safety, integrity, authenticity and control of the documentation can be ensured, as well as how to make them accessible and correctable. In other words, this webinar is all about how to meet regulatory requirements pertaining to documentation, a basic requirement of the Quality Management Systems.

Susanne will cover the following topics at this webinar:

o  FDA expectations for Document Controls and Records Management

o  Lessons Learned from 483s and warning letters

o  Common problems and mistakes

o  Strategy for Document Control

o  How to structure your QMS and Document Management System

o  Methods and systems for controlling documents

o  Records retention

o  Best Practices

o  Preparing for an FDA Inspection

Microbial monitoring becomes successful when myths about the topic are removed

Although unfortunate; it is true that those who work in water systems design them keeping obsolete concepts in mind. Why this happens is that the water systems organization is reluctant to be open-minded enough to update its water systems from time to time. The result is that the water systems get built on a shaky foundation, making them fundamentally weak.

Myths are the backbone of water systems failures

An additional problem faced by most microbial monitoring systems is the number of myths that have emerged from this field, which is mainly due to the major misunderstanding that professionals have regarding the topic of microbial monitoring.

Addressing these myths is the main purpose of a webinar that Compliance4All, a highly reputable provider of professional trainings in a number of areas including regulatory compliance, is organizing.

This webinar, for which water systems professionals in a number of positions can enroll by just logging on to http://www.compliance4all.com/control/w_product/~product_id=500969LIVE, will be from none other than the world renowned expert on pharmaceutical water systems, Teri C. Soli.

An in-depth look at the fallacies and misconceptions of water systems implementation

Dr. Soli will discuss the reasons for which such fallacies happen, but greater attention will be paid to how these systems can be corrected. He will drive home the point that if this has to happen, a few established myths have to be shattered.

This session seeks to quash popular myths surrounding water systems, the most important reason for which water systems go awry. Most of these myths relate to microbial control approaches and microbial monitoring. For microbial monitoring to be effective, myths resulting out of misconceptions need to be removed from many areas.

Putting the myths and facts in perspective

During this webinar, Dr. Soli will take up and demolish each myth surrounding water systems and will explain the scientific, not the “rule of thumb” approach, to each of these.

He will take up the following areas for discussion and set many misconceptions surrounding them right:

o   Why water myths develop:

·        Impact of c-GMPs

·        Well-meaning but misguided precedents

·        Scientifically unchallenged traditions and benchmarking

·        Rule-hungry culture

o   Water System Microbial Control Myths:

·        WFI from RO

·        Turbulent Flow and Flow Rate

·        Dead Leg Rules

·        Smooth Surfaces

·        In-Line Sterilizing Filters

·        Ozone

o   Microbial Enumeration Myths:

·        Referee Methods

·        Thermophiles in Hot Systems

·        R2A, 35°C, 5 days

·        Test Filter Membrane Rating

·        Compendial Action Levels

·        TOC and Endotoxin as Microbial Count Correlates

Contact Information:

http://www.compliance4all.com/

+1-800-447-9407