Works Quickly Meeting the FDA’s Quality and compliance requirements

Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?

This is simply not the case. Quality and compliance are built into a medical device product. It is only that companies need to have the capabilities needed for meeting Quality and compliance requirements from a regulatory perspective. If medical device companies have to be successful in their endeavors in the future, they have to be adept at how to meet quality and compliance requirements set out by the FDA.

Quality and compliance to meet regulatory requirements

Why is this needed? Simple: If medical device companies do not meet regulatory requirements set out by the FDA; they are not likely to meet the quality requirements demanded of their products. As a result, apart from being unable to create products that appeal to customers, they could end up facing punitive actions from the FDA.

As said, meeting Quality and regulatory compliance requirements is not something of a gamble. Quality and compliance, which are the key inputs for meeting customer demands, can be fulfilled by putting a thorough process in place. These are capabilities a medical device company needs to have if it has to meet quality and compliance requirements and succeed in the market.

Learn the ways of meeting Quality and regulatory requirements from the expert

The method by which medical device companies can achieve regulatory compliance requirements and ward off punitive actions from the FDA will be taught at a very interesting and lively webinar from Compliance4All.

The speaker of this webinar, 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, will demonstrate just what medical device companies need to do in order to meet Quality and regulatory compliance.

To gain complete insights into how medical device companies can take the requisite steps needed for meeting quality and compliance requirements, please enroll for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501160?Wordpress-SEO

An explanation of the seven capabilities needed for meeting quality and compliance requirements

At this session, Susanne Manz will explain that there are seven capabilities that are needed for medical device companies to accomplish their aim of meeting Quality and regulatory compliance requirements. She will explain these and offer complete understanding of how the changing regulatory climate needs to be comprehended. She will show how to evaluate one’s capabilities to develop a regulatory strategy that will help companies meet their requirements, so that they become successful in the pursuit of their objectives.

Susanne will show how to develop strategy from one’s self-awareness of the Quality and regulatory requirements. At this webinar, she will cover the following areas:

o  Evolving Regulatory Climate

o  Seven Key Capabilities for Success

o  How to evaluate and map your capabilities

o  Quality Planning and Improvement

o  Maturity Modeling

o  Developing Your Quality and Compliance Strategy.

A look into the 21st Century Cures Act

Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.

The 21st Century Cures Act aims at strengthening funding for the National Institutes of Health (NIH) by allocating over $ six billion to them. Of this, nearly $ five billion will go towards biomedical research funding. One of the highlights of the 21st Century Cures Act is the allocation of nearly $ two billion for the “Beau Biden Cancer Moonshot” initiative, which is in honor of the Vice President Joe Biden’s son, who succumbed to brain tumor.

A different take on health improvement

This approach is a significant one, considering that researchers from some of the nation’s best-known science universities depend on NIH funding for their research. Nearly two thirds of the major drugs that are in the market since 2000 have been the result of NIH research.

In addition, the 21st Century Cures Act will also have a major impact on mental health. This is one of the most notable features of this Act. It allocates over a billion dollars for addressing opioid and other addictions in the US, and the health-related complications that arise from them, which is a significant contributor to the fall in national health standards and productivity of the population in its prime.

Will the 21st Century Cures Act change the FDA approval process?

While addressing this core aspect of scientific research in helping to treat chronic diseases; the 21st Century Cures Act also focuses on another very critical point of medicines: The FDA. Since no drug can ever enter the market without FDA approval and the FDA approval process is very lengthy, expensive and cumbersome; the 21st Century Cures Act seeks to address this fundamental issue by suggesting changes into the approval process for new drugs, as well as medical devices.

Concerns and criticisms

Reservations have been expressed about the effectiveness of the 21st Century Cures Act. The main concern is that the regulatory approval process of drugs from the FDA could get diluted, causing a risk to the lives of the patients, thereby reducing the ability of the FDA to protect lives with its regulations.

There are many issues at stake in this highly important legislation. A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will discuss the prospects and downsides of this very important law.

At this webinar, John E. Lincoln, a very experienced medical device and regulatory affairs consultant, will offer a complete insight into the provisions of the 21st Century Cures Act. This webinar will be highly meaningful and useful for research institutions and organizations that are directly concerned and connected with the FDA and its administration of emerging technologies and general health. Enroll for this webinar by registering at http://www.compliance4all.com/control/w_product/~product_id=501213?Worpress-SEO

Analysis of all the major aspects of the 21st Century Cures Act

John will explain and analyze all the main areas of the 21st Century Cures Act. He will scrutinize how the Act will concern the FDA, the impact it will have on other areas of the Federal government, and the possible benefits and drawbacks for industries and research institutions that will get directly and indirectly affected by the Act, and the general public.

John will cover the following areas at this webinar:

  • The Act’s 3 Main Areas
  • Increased Funding for Medical Research
  • Speed the Development and Approval of Experimental Treatments
  • Overhaul Federal Policy on Mental Health Care
  • Stated Advantages
  • Concerns Expressed
  • What Has Happened So Far

http://www.foxnews.com/health/2017/01/24/how-21st-century-cures-act-will-save-lives-through-research.html

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

Developing effective legal writing skills for FDA submissions

Effective legal writing skills for FDA submissions need to be nurtured for a number of valid reasons. This is because the documents that go into FDA submissions are highly technical and heavy in nature. When companies make submissions to the FDA, they submit highly complex studies that are very scientific and technical. When professional who work in this field seek to make submissions to the FDA; effective legal writing skills for FDA submissions go a long way in making these documents comprehensible and palatable.

Most law schools prepare future attorneys by inculcating into them the art of condensing and finessing complex and heavy textual and academic matter into crisp, succinct and persuasive arguments. These kinds of writing skills are all the more important when the company has to draft responses and applications to FDA. Since these responses are expected to be highly precise and put forth arguments that are of a highly scientific and technical nature; developing the art of effective legal writing skills for FDA submissions is a must.

Making submission documentation free of heavy text

Making submissions about the product is not the only reason for which effective legal writing skills for FDA submissions need to be imbibed. There is another important one, which is that companies have to wade through a maze of heavy, often confusing regulations. These regulations are legally binding requirements that are based upon statutory laws and judicial opinions.

On most occasions, professionals in the pharmaceutical and medical device companies need to deal with these and respond to these at required times. To do this, they need to have a full grasp of these requirements if they have to clearly understand, and have to effectively use effective legal writing skills for FDA submissions to frame persuasive argument and to negotiate with the FDA.

Effective legal writing skills for FDA submissions can be the difference between success and failure of drug submissions

In fact, the use of effective legal writing skills for FDA submissions is so important that many a time, effective legal writing skills for FDA submissions can decide the difference between the success and failure of many new drugs, biologic or medical device projects.

The more persuasive and articulate these arguments; the greater the chances for the company’s products of getting approvals from the FDA. This is because a document that is confusing and is laden with incomprehensible jargon confuses the regulatory authorities. Hence, effective legal writing skills for FDA submissions are utterly important for legal drafting skills when preparing quality and regulatory documents.

Learn the art of effective legal writing skills for FDA submissions

Want to discover all the aspects of effective legal writing skills for FDA submissions? These will be imparted at a webinar that is being organized by Compliance4All, a highly cost-effective provider of professional trainings in all the areas of regulatory compliance.

Robert Michalik, a Massachusetts regulatory attorney and founder of RegulatoryPro.com will be the speaker at this webinar. To understand the importance of and to imbibe the skills needed for effective legal writing skills for FDA submissions, please register for this webinar by just visiting

http://www.compliance4all.com/control/w_product/~product_id=501217?Wordpress-SEO

Effective legal writing skills for FDA submissions can even override flaws in test results

At this very valuable webinar on effective legal writing skills for FDA submissions, Robert will familiarize participants with the legal writing skills and practical techniques that will enhance their chances for success, to the extent of even making up for some lapses in their test results or other supporting information. While good regulatory writing will meet FDA branch-level requirements; effective submissions that are laced with effective legal writing skills for FDA submissions can withstand scrutiny at the FDA Division level.

At this webinar, Michalik will cover the following areas:

o  Basic communications skills that all successful attorneys use to win arguments, in legal briefs and oral presentations

o  Step-by-step analysis of how to present both good and poor data in a persuasive manner

o  How to train scientists and engineers to generate “good” data to support legal, regulatory and quality claims?

o  Tips and secrets to framing an argument that makes even poor data look good

o  Examples of good writing that can be useful templates for training and skills development

o  What you should never say in a quality or regulatory document?

The Attribute Agreement Analysis

Humans can be calibrated, although most people like to think otherwise. The commonly used standard, Attribute Agreement Analysis, or what is called AAA, is a handy tool in helping to do this. At its barest, Attribute Agreement Analysis is a method in which the level of agreement or conformance between the appraisal made by the appraiser(s) and the standard is assessed. Then, the elements used for the appraisal that have the highest levels of disagreement with the standard are identified.

The two methods of the Attribute Agreement Analysis

The Attribute Agreement Analysis uses two primary methods of assessing the agreement of the attribute with the standard:

–       The percentage or extent to which the appraisals agree with the standard

–       Kappa statistics, or the percentage or extent to which adjustment is made between the agreement between the appraisals and the standard and the percentage of agreement that happens by chance

The three aspects of Attribute Agreement Analysis

Attribute Agreement Analysis has three aspects: Agreement with oneself, Agreement to a peer, and Agreement to the standard. When calibrating humans, the use of Attribute Agreement Analysis calls for control plans that need to be in put in place for “MSA” analysis on key processes. An AAA may be described as a “Measurement Systems Analysis” (MSA) for attributes.

The Attribute Agreement Analysis method is useful to auditing professionals, to whom it makes sense to understand the effectiveness of these methods when these are used by their clientele and/or in their own organization.

Gain learning of Attribute Agreement Analysis

The ways by which Attribute Agreement Analysis can be comprehended and used effectively will be the learning a webinar being organized by Compliance4All, a provider of cost-effective regulatory compliance trainings for a wide range of regulated industries, is offering.

The speaker at this webinar is Jd Marhevko, Vice President of Quality and Lean for Accuride Corporation, who has been involved in Operations and Quality/Lean/Six Sigma efforts across a variety of industries for more than 25 years. To gain insights into the inner aspects of Attribute Agreement Analysis, please register for this webinar by logging on to

http://www.compliance4all.com/control/w_product/~product_id=501073?Wordpress-SEO

The “Statistical AAA” and the Kappa value

At this webinar, Jd will review both the “Statistical AAA” and the Kappa value, as well as the confidence levels for the result bands and incorporation of AAA into the Control Plan and frequency of calibration.

She will assess the pros and cons while discussing the general benefits of reductions in arguments (what is good or not) internal/ external rework, returns, premium freight, etc.

A number of uses from the Attribute Agreement Analysis method

This explanation will help participants understand ways by which they can apply this tool while learning how to bring down business costs. Jd will evaluate the benefits of human calibration by reviewing the three basic types of agreements.

The important learning this session will give is that it will enable participants to learn the ways of developing, creating, executing and interpreting an Attribute Agreement Analysis so that an accurate and repeatable disposition can be made and rework and returns can be effectively reduced.

At this webinar on Attribute Agreement Analysis, which will be highly useful to professionals such as Quality and Engineering system practitioners, Directors, Engineers, Analysts and Managers, Jd will cover the following areas:

o  To help people understand how AAA can be effectively utilized for mitigating business loss

o  Increased understanding of how to actually perform the analysis

o  Build confidence in the ability to calibrate a human operator.

http://support.minitab.com/en-us/minitab/17/Assistant_Attribute_Agreement_Analysis.pdf

http://support.minitab.com/en-us/minitab/17/topic-library/quality-tools/measurement-system-analysis/attribute-agreement-analysis/what-is-an-attribute-agreement-analysis-also-called-attribute-gage-r-r-study/

Demonstrating Product Reliability

Product Reliability is among the most important attributes for a product, no matter what kind of product one is considering. Product Reliability can be defined as the likeliness or probability of the product performing its stated purpose, in the light of the conditions under which it is going to be put, for a defined period of time.

The parameters used for quantification of Product Reliability are:

o  MTBF or Mean Time Between Failures for products that can be repaired and used, and

o  MTTF or (Mean Time To Failure) for products that cannot be repaired.

If these are the parameters used for quantifying Product Reliability, how does one predict it? Quality professionals use a relatable analogy to explain how to assure measurability of Product Reliability. This is known as the bathtub curve analogy, where the start or early life of the product is placed at the start of the bathtub. As the product starts getting used, it moves on to the phase of its useful life, from where it moves on to its wear out time.

The time taken for each of these processes is the indication of Product Reliability. Product reliability using the bathtub curve analogy suggests that at the beginning of the product lifecycle, the probability of failure rate is relatively less. As the product progresses on to its next phases, the probability of failure rate increases. This is the root of the understanding of predicting Product Reliability. Mathematical formulae are used to describe these.

How does on get Product Reliability right?

The ways of choosing the right reliability parameters for failure rates of respective products and estimating their lifecycle in the light of failure rates will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Steven Wachs, Principal Statistician at Integral Concepts, Inc. where he assists manufacturers in the application of statistical methods to reduce variation and improve quality and productivity, will be the speaker. To benefit from the experience Steven brings into Quality, please register for this webinar by logging on to

 

http://www.compliance4all.com/control/w_product/~product_id=501164?wordpress-SEO

A description of the various approaches to Product Reliability

Steven will offer and explain several approaches that can be used to verify whether reliability targets or specifications have been achieved at the desired level of confidence. In particular, he will describe the approaches using time-to-failure data to estimate reliability metrics.

Also taken up at this session, which will be of immense use to anyone with a vested interest in product quality and reliability, such as Product Engineers, Reliability Engineers, Design Engineers, Quality Engineers, Quality Assurance Managers, Project/Program Managers, and Manufacturing Personnel are demonstration tests, where minimum reliability may be demonstrated with zero or few failures.

A description of the methods that increase the risk of failures

Steven will discuss the kind of methods, which when used, increase the risks of field failures due either to inadequate designs or misconstruction of product use conditions that need to be managed. He will also offer the options for verifying and demonstrating that customer reliability requirements have been achieved.

Steven will cover the following areas at this webinar:

o  Overview of Reliability

o  Reliability Metrics and Specifications

o  Estimating Reliability with Time-to-Failure Data

o  Confidence Intervals and Bounds

o  Demonstrating Reliability with zero or few failures

o  Tradeoffs between Testing Time and Sample Size

o  Impact of Assumptions on Test Plans

o  Improving Demonstration Test Power

http://ftp.automationdirect.com/pub/Product%20Reliability%20and%20MTBF.pdf