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

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

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

Disastrous consequences of lack of proper controls

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

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

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

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

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

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

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

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

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

She will cover the following areas at this webinar:

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

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

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When SSARS does and does not Apply to Preparation Engagements

The Statement on Standards for Accounting and Review Services (SSARS) is a section of the professional standards set out by The American Institute of CPA’s (AICPA), seeking to review earlier standards for reviewing and compiling financial statements and setting out the terms of engagement between the CPA’s and the parties. This section has been set out by the Clarity Project of the AICPA’s Accounting and Review Services Committee (ARSC). The terms of engagement constitute a principal element of Section 21 of the SSARS.

The AICPA’s Section 21 is a significant improvement over the earlier standard, Section 19. Having come into effect in December 2015; AICPA Section 21 overrides the earlier standards. On its part, Section 19 was considered an improvement over the existing standards that had been getting enacted from 1978. It stressed the importance of the independence of the CPA, in that they should not be part of the board or management of the company whose accounts they are auditing. It also required the CPA to obtain an engagement letter before proceeding to prepare and issue financial statements.

 

Supersedes Section 19

Where Section 21 goes beyond Section 19 is in setting out the clear terms for a new service, that of preparing financial statements. Also, it takes changes brought about by technologies such as the cloud into the accounting profession, into consideration. It sets out these requirements in its four sections, sections 60, 70, 80 and 90. Briefly, these are what these sections represent:

Section 60: Describes the General Principles for Engagements performed in accordance with Statements on Standards for Accounting and Review Services

Section 70: Preparation of Financial Statements

Section 80: Compilation Engagements

Section 90: Review of Financial Statements

The highlight of Section 21 of SSARS is that these sections are clearly demarcated. One prescribed action should follow the other, only after the one taken up is completed. It draws a distinction between, for instance, financial statement preparation and a compilation, which is something that CPA’s have to submit for any financial statement submitted to third parties. In this way, Section 21 is a comprehensive set of regulations.

Complete clarity on Section 21

Want to understand how this section relates to your profession? Want to gain clarity and insights into the ways of the workings of this section? A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, has all the answers relating to the comprehension and implementation of Section 21 of the SSARS.

At this session, Candace Leuck, who owns Athena Finance Group, Inc., which specializes in strategic planning, distressed entity recovery, valuations, and educational programs; will be the speaker. To register for this highly interesting and valuable webinar, please visit Compilation and Review Updates

Understanding of all aspects of Section 21

The aim of this presentation is to familiarize participants with all the sections of SSARS 21. Participants will be able to understand general requirements for SSARS engagements and learn details of new financial statement preparation engagement requirements. Since Section 21 both supersedes Section 19 and differs from it in many ways, Candace will explain the details pertaining to understanding and implementing Section 21, which includes requirements for engagement letters, requirements for understanding of the client, industry and environment, when SSARS does and does not apply to preparation engagements, attest versus non-attest engagements, reporting requirements, and disclosure requirements.

She will cover the following areas at this webinar:

o  Understand general requirements for SSARS engagements

o  Learn details of new financial statement preparation engagement requirements

o  Review compilation and review engagement requirements

o  Discuss the elimination of “management use only” compilations

o  Understand new formats for compilation and review reports

o  Compare and contrast preparation, compilation and review engagements.

This webinar will be of high use to personnel whose work requires them to implement Section 21 of SSARS, such as Public Accountants, Managerial Accountants, and Financial Accountants.

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Who Benefits from the changes, and How it will affect the Retailers and Customers

Credit card surcharge was the bone of contention in an antitrust lawsuit filed 2005. As a result, the judgment in this case, which came in mid-2012, prohibited credit card surcharge in ten States. The implementation of their respective laws is underway in another 12 States.

Credit card regulations have traditionally opposed surcharging. Yet, companies have been devising ways by which they have sidestepped merchant rules and have continued to ensure that credit card surcharge gets levied. A kind of cat and mouse game is currently being witnessed, with State laws continuing to override networks merchant rules and companies looking out for ways to skirt the laws.

The issue of credit card surcharging in the US

The reason for which credit card surcharge is an issue for businesses is that it is the last link in the payment chain. A business that makes use of this facility incurs this expense at the rate set out by the authorities. It can be understood as a checkout fee that gets added to every consumer’s shopping bill whenever a credit card is used to make payments for the purchases made at the business. Businesses are not willing to bear this expense, and naturally, like to pass it on to the consumer.

What the court judgment of 2012 did was to permit charging of credit card surcharge for certain card transactions from January 2013. This judgment brought about a change in not only merchant processing transactions but also of credit card usage. The settlement it directed makes it mandatory for businesses that levy the credit card surcharge to follow requirements relating to consumer disclosure and to set limits on the amounts for which the surcharge is collected.

In addition, those businesses that accept credit cards to receive payments should also notify Visa and their acquirer of their decision to charge credit card surcharge a month before they begin to levy the surcharge. These rules vary from State to State, and the business is free to choose the brands of its outlet for which it wants to keep the credit card surcharge.

Total clarity on the issue

Sorting out the various confusions and misunderstandings pertaining to the credit card surcharge issue is the purpose of a webinar that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing. The speaker at this session, Ray Graber, a highly experienced professional in the payment industry, who brings deep and profound understanding of the way banking and finance converge with technology, will clarify the issues relating to this topic at this webinar.

In order to have your issues relating to credit card surcharging cleared, please visit payment methods like checks and cash to register for this webinar.

Clarity on all aspects of credit card surcharging

The aim of this webinar is to clear the muddle that has resulted from the changes in the rules. The speaker will explain who benefits from the changes, and how these changes are going to affect the retailers and customers. The adverse consequences of an uninformed reaction to surcharging by end-user organizations will be explained. Ray will emphasize the importance of first looking at the big picture of credit card surcharging, as end-users should also educate suppliers about the economics of card acceptance, explaining to them the savings possible and other benefits.

Business logic dictates that suppliers should not be adding a surcharge when they are reaping the rewards. Ray will explain how they might overlook the benefits of card acceptance, as well as the cost of other payment methods like checks and cash.

At this webinar, Ray will cover the following areas:

o  What changed in the rules?

o  Why did it change?

o  What rules apply to surcharge?

o  Survey results

o  Who may benefit?

o  Will this change anything?

o  Summary.

This learning session will offer benefit to every level of employee who works in the credit card industry, such as financial officers, small business owners, corporate risk officers, internal auditors, operational risk managers, credit card program administrators, CPA’s and attorneys and legal staff.

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How to test your firm’s Compliance Program based on what the Regulators are Focusing on

The financial regulators publish a listing of their exam initiatives for the upcoming year. Financial advisers use this listing to anticipate what thinking the regulators bring into a financial year, which will have a major bearing on the financial industry. This listing offers financial advisers an idea of what to expect during a particular financial year.

For instance, taking off from the backdrop of the financial crisis of 2007 to 2009; the financial regulatory priorities listed out in a study carried out by Harvard included the following:

o  Increased capital regulation

o  Improved stress testing and capital planning

o  Regulation of the liquidity requirements

o  The need for learning the tools for regulatory migration across financial institutions

o  The authority the regulatory agencies have in regulating large financial institutions

These constitute the broad items of financial regulatory priorities. Financial advisers may use these financial regulatory priorities issued at a particular point of time to make assessments and calculations that help them arrive at decisions which they pass on to investors. However, different priorities emerge from time to time, simply because the financial situation is fluid and ever evolving.

Based on evolving priorities and situations

Financial advisers may make valuations and offer honest advice to investors about the financial markets, but these can be subject to flux. In the event of these changing goals and situations; it is not possible to arrive at black and white conclusions about the priorities.

Financial professionals and those who take their advice need to be fully alert to the happenings in the financial landscape if they have to arrive at the right decisions. How do they do that? What is the basis on which the exam initiatives need to be understood in order to facilitate sensible decision-making about finance?

Learning about how to understand exam initiatives

This is what a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering at a webinar. This webinar will have Lisa Marsden, IACCP, who is the President and Founder of Coulter Strategic Services. Coulter Strategic Services, which provides Financial Advisors and compliance consulting firms with compliance and project management services, as the speaker.

Please visit day to day tasks of financial compliance to enroll for this webinar and gain clarity in understanding the details set out in the regulatory exam initiatives.

Understanding how the priorities suit participants’ organizations

The speaker will explain what each financial industry participant needs to know about this year’s regulatory initiatives. She will highlight the importance of learning from priorities that are involved in the day to day tasks of financial compliance.

She will show how participants can learn the ways of reviewing the regulator’s annual priorities list and incorporating the priorities that relate to their own firm into their compliance program. The ways by which to test the specific areas and how to remediate any issues found, will be explained. Beyond the priorities, Lisa will also show how to find out what to expect from exams and how to test the suitability of the participants’ compliance program based on what the regulators are focusing on.

Lisa will cover the following areas at this webinar:

o  Learn how to gain access to the financial regulators priorities

o  Understand how to apply those priorities to your firm

o  Incorporate the priorities into your annual review

o  Distinguish which priorities need to become part of the Compliance Manual/Code of Ethics

o  Determine what your firm’s financial regulatory priorities should be

o  Other sources for annual priorities.

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How to create Slicers which are the New Visual way to Filter a Pivot Table

Microsoft Excel can be used to carry out a number of functions such as sorting, filtering, and subtotal to manage large lists of data. Yet, its MS Excel PivotTable is a very useful feature when it comes to analyzing all that data and doing it quickly. Its use is all the more pronounced when the user is required to quickly create a compact summary report (based on lots of data) without having to write complex formulas or rely on lengthy techniques.

Being very versatile, MS Excel PivotTable is often considered Excel’s best analytical tool because it complements speed with amazing flexibility and dynamism, by which the data interrelationships that are being viewed can be changed. It is so practical that its features can be put to practical use by actually getting down to work on it, even if a user doesn’t go through the instructions on the printed page, which is a visually-oriented feature based on displaying fields in different locations. With MS Excel PivotTable, it is possible to create a complete summary report with heaps of data in very little time without having to write complex formulas and rely on obscure techniques.

Thorough learning about all the features and aspects of PivotTable from the MS expert

A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer complete learning on the numerous PivotTable capabilities and its many tools and features.

The speaker at this session is Dennis Taylor, an Excel expert who has worked extensively with Microsoft products (especially spreadsheet programs) since the mid-1990’s and has taught hundreds of workshops and authored numerous works on this program. Please register for this webinar by visiting best ways to create PivotTables and gain complete insights into the ways by which to put the full range of functionalities of MS Excel PivotTable to use.

PivotTable simplified

Teaching participants the quickest and best ways to create PivotTables and Pivot Charts is the main objective of this webinar. These include the following capabilities:

o  How to compare two or more fields in a variety of layout styles

o  How to sort and filter results

o  How to perform ad-hoc grouping of information

o  How to use Slicers instead of filters to identify which field elements are displayed

o  How to drill down to see the details behind the summary

o  How to categorize date/time data in multiple levels

o  How to create a Pivot Chart that is in sync with a PivotTable

o  How to add calculated fields to perform additional analysis

o  How to hide/reveal detail/summary information with a simple click

o  How to deal with dynamic source data and the “refresh” concept

o  How to create a PivotTable based on data from multiple worksheets.

All these aspects will be covered in detail. Dennis will also cover the following areas at this session on MS Excel PivotTable:

o  Pre-requisites for source data – preparing data so that it can be analyzed by PivotTables

o  Creating a PivotTable with a minimum number of steps, including the Recommended PivotTables option

o  Manipulating the appearance of a PivotTable via dragging and command techniques

o  Using Slicers to accentuate fields currently being shown (and which ones are not)

o  Using the new (in Excel 2013) Timeline feature

o  Creating ad hoc and date-based groupings within a PivotTable

o  Quickly create and manipulate a Pivot Chart to accompany a PivotTable

Apart from MS Excel users who are familiar with PivotTable concepts, but need expanded techniques to analyze lists of data; anyone needing to know how to create PivotTables from multiple sources and use Slicers, Timelines, Calculated Fields, and Conditional Formatting will also benefit from this course.

For Depth info

What You Need To Know For Validated Systems?

Instances of cyberattacks that lead to disruption of service, data theft or compromise and even ransomware are making the news headlines of late with alarming frequency. Cyberattacks are carried out because computer systems used in highly regulated companies house very sensitive and valuable information.

Data relating to valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information are usually placed in these systems, which is what makes them targets of cyberattacks. Cyber attackers have become so sophisticated and emboldened in recent times that they have not even spared the White House.

Computer Systems Validation has a major role

Companies that hold vital information should ask themselves many questions on this topic. Some of these include: Will my company able to cope with a breach of one of our validated systems? How secure is the information we have stored in the cloud? Are we conducting adequate due diligence on our cloud provider?

Even as the dependence on the cloud, by which life sciences companies are increasingly implementing and deploying systems in a cloud environment goes up; the procedures and controls to effectively manage and protect their validated systems environments is somewhat inadequate.

In the current situation of higher and stronger attacks on computer systems unaided by solid safety and security guarantees; Computer Systems Validation (CSV) has a critical role to play. Validation engineers need to take a serious relook at testing strategies. They must look at systems that provide objective evidence that computer systems have the requisite technologies, processes, and practices designed to protect networks, computers, programs, and data from attack, damage, or unauthorized access.

There is an acute need for validation engineers to be more vigilant in today’s systems environment that is sometimes hostile, in order to detect and prevent cybersecurity issues before they become real problems. Proper and diligent CSV goes a long way in helping to ensure that this happens.

Valuable learning on lean validation 

The ways of doing this will be the learning a valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. Valarie King-Bailey, who is the CEO of OnShore Technology Group, an independent Chicago-based consultancy founded in 2004 specializing in Independent Validation and Verification (IV&V) services and solutions; will be the speaker at this webinar.

Please enroll for this webinar by visiting concept of Cybersecurity Qualification

Full aspects of cybersecurity

The regulatory, legal, compliance and business risks associated with the threat of cybersecurity constitute the core of this webinar. It will address the unique threat of cyberattacks on validated systems environments and discuss how to mitigate and protect validated systems.

As validation engineers continue to conduct IQ, OQ, PQ, CyQ testing must be added as a defense against cyberattacks to validate computer systems.  Valerie will discuss the NIST Cybersecurity framework and how it can be applied to validated computer systems. She will also discuss a new level of qualification for validated computer systems known as Cybersecurity Qualification (CyQ), a concept she will introduce at this webinar.

Being organized for the benefit of enterprise and validation professionals such as validation engineer, validation project manager or software quality engineer, and IT Managers, Directors, VPs, Chief Information Officers, Quality Assurance/Quality Control Managers, Validation Engineers, Validation Project Managers and Program/Project Managers; this webinar will cover the following areas:

o  The Cyber Threat Megatrends: What You Need to Know for Validated Systems

o  Understanding Cybersecurity Regulatory Guidance and Standards

o  Cybersecurity Qualification: The NEXT Frontier

o  Automated Testing in the Cloud

o  Top 20 Critical Security Controls for Validated Systems

o  Cloud Security Technology Maturity

o  Cloud Quality Assurance & Governance

o  The Changing State of Computer Systems Validation in a Cyber World

o  Understanding the NIST Cybersecurity Framework for Validated Systems.

Here to continue further How to mitigate and protect validated systems

What Should be Included in a Calibration Program

One of the very important activities for a laboratory is calibration. The terminology found in 21CFR160 (b) (4) spells out the requirements for this aspect of medical devices. In addition, other terminologies and concepts that need to be applied for an effective calibration program, but are not found in the regulation, such as instrument classifications, also need to be taken into consideration.

Given this fact, it is important for professionals who work in laboratories to ensure that the laboratory has an instrument calibration program that assures that the instruments are calibrated at appropriate intervals using specific procedures that define the standards and tolerances that are relevant to and appropriate for the intended use of the instrument.

A well-structured learning session on calibration in the laboratory

All the core and supplementary aspects of laboratory calibration will be taught at a highly valuable learning session that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.

At this webinar, Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker. To gain complete understanding of all the important aspects of laboratory instrument qualification, please enroll for this webinar by visiting What Should be Included in a Calibration Program

Imparting understanding of the standards

The speaker at this webinar will show to participants how to apply measurement uncertainty or test accuracy ratio to specific calibration procedures, as well as the selection of standards needed to provide scientifically sound calibrations traceable to national references.

Building on the terminology found in 21CFR160 (b) (4); Jerry will base his teaching by relating and applying the concepts discussed to specific key instruments found in the testing laboratory. This learning will improve participants’ understanding of calibration and help them understand the ways by which to apply these concepts.

Jerry will cover the following areas at this session:

o  The regulatory and technical requirements for calibration.

o  What should be included in a calibration program

o  The importance of a data-based calibration interval and limits of accuracy and precision

o  The impact of measurement uncertainty when establishing limits of accuracy

o  The classification of test instruments

o  Current practices in the calibration of specific instruments

Laboratory Managers, Laboratory Supervisors, Laboratory Analysts that are responsible for the calibration of laboratory instruments, Laboratory Record Reviewers, Quality Assurance record reviewers and Quality Assurance Managers will gain important learning from this webinar.