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.

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

Analyzing financial statements is an indispensable insight for managers

Financial statements are the ultimate indicator of a company’s financial health. Number crunching is a very important exercise that all executives at all levels of an organization need to be familiar with. Yet, given the heavy jargon that goes into financial statements and the complexity most of them have; many managers feel put off and don’t generally like to pore over financial statements.

The company’s financial statement is intended to provide insights into the most important aspect of the business –the financial one –to managers and executives at all levels and in all disciplines. Marketing, finance, HR, customer service, and sales need financial statements to get a grasp of and gain perspective of the financial health of the organization.

Financial statements are critical for helping understand the business

Despite financial statements being the surest indicator of the most important aspect of any business organization –Finance –most managers lack the perceptiveness needed to understand and analyze the meaning of numbers. It is often that they devote some much time to running their business that the priority that needs to be accorded to understanding financial statements gets buried and takes a backseat.

A perceptive analysis of financial statements is the foundation to getting the business in order. Wading through the numbers helps the organization to dig into the market trends, understand where they are getting it right or wrong, and then use financial statements to draw proper conclusions and take appropriate action. It is important to understand financial statements for another critical reason: The competition should not understand our financial statements faster and better than we do!

Trend and ration analysis of financial statements

But how does one make sense of heaps and heaps of seemingly unintelligible numbers? Numbers in themselves, without the necessary nous to decipher them, make little sense to any executive. A few techniques do exist to help understand the meaning of numbers. An effective model for assessing the financial condition and results of operations of any business is that of using trend and ratio analysis. Getting a grasp of this model will empower financial and other executive teams to derive the maximum benefit that accrues from a crystal clear understanding of financial statements.

Imparting this understanding is the intent of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all areas of regulatory compliance. Miles Hutchinson, an experienced CGMA and business adviser, will be the speaker at this session.

In easily comprehensible terms, he will explain how participants can imbibe the sagacity needed to quickly and thoroughly analyze the financial condition and results of operations of any publicly traded company. All that is needed to gain this highly useful understanding of financial statements is to register for this webinar by logging on to

http://www.compliance4all.com/control/w_product/~product_id=501197LIVE?wordpress-SEO

Attending this highly useful session on financial statements gives Financial Executives, HR Managers, Accounting Managers, Department Managers, and Business Unit Managers the ability to discern numbers and help understand where these numbers lead the organization to.

These are the areas this webinar on financial statements will cover:

o  Review the components of the annual report of a prominent publicly traded company and learn how to use this wealth of information

o  Use the annual report to perform a fundamental financial analysis

o  Learn the various types of financial analysis and their purpose

o  Learn the key ratios to evaluate a company’s liquidity, leverage and operating performance

o  Identify the key benchmarks to help determine whether a company’s ratios are in line with competitors

o  Understand horizontal and vertical analysis and how they can be used to identify key trends

o  Bonus: receive our advanced excel hosted financial model complete with all ratios, horizontal and vertical analysis

o  Use our model to perform financial analysis on other company financial statements, including yours

o  Receive benchmark information to use in determining the quality of your analyses

Learn about resources available to perform comparative studies between companies in the same economic sector – even private companies.

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

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