What is the legal language of the FDA form 1572 or Device equivalent?

Form FDA 1572 is one of the primary documents needed when carrying out a clinical trial. Also called the Statement of Investigator; Form FDA 1572, called just 1572 informally, is a contract between the Principal Investigator (PI) and the FDA. This form contains all details of the subjects, as well as commitments from the PI.

It is a contract in which the Principal Investigator, the person who is in charge of the clinical trial, gives an undertaking to the FDA giving it the assurance that she will comply with all the requirements set out by the regulatory agency with regard to the trial.

By signing the FDA form 1572, which relates to IND studies, or the “Statement of the Investigator, which is meant for IDE studies; the PI is submitting herself to all the appropriate regulations, as this is a legally binding document by which they commit themselves to follow all of these.

The 1572 is meant to serve two important purposes:

It is a way of helping the FDA, as well as the sponsor of the study to qualify the PI, i.e., it gives the FDA and the sponsor of the study the opportunity to understand the Principal Investigator’s qualifications and ability to carry out the research in terms with the purposes it seeks to fulfil. It is also a way to verify that the site at which the clinical study is being carried out is appropriate for the study.

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The Form FDA 1572 also has another important purpose to fulfil.  It takes an undertaking from the Principal Investigator that the requirements set out by the FDA will be met during the trial. Failure to adhere to these commitments is considered a criminal offence, as something amounting to making false statements, and is liable for legal action under the terms set out in 18 USC 1001. This form has to be submitted whenever the sponsor selects the Principal Investigator to take charge of a clinical trial that is being conducted as an investigational new drug (IND) meets the criteria set out in 21 CFR 312.53 (c).

Other documents

Further, other documents such as 21 CFR 312.50, which deals with the General Responsibilities of Investigators, 21 CFR 812.100, which deals with the Responsibilities of Investigators for Biologics, and 21 CFR 812.110, which deals with the Responsibilities of Investigators for devices, need to be adhered to.

All these documents set out the general and specific responsibilities that the Investigators have when conducting a clinical trial. These start from who can qualify to be considered a PI to what qualification criteria sub investigators and research staff need to have.

A proper understanding of Form FDA 1572

FDA Form 1572 is thus an extremely important document that needs to be complied with fully if the clinical trial has to be considered compliant with the regulatory requirements. A full understanding of all the aspects that go into this will be spelt out at a webinar that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing.

This webinar educates participants about the due diligence that investigators and their staff about their regulatory and legal responsibilities. Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena, will be the speaker at this webinar. In order to gain complete knowledge of this valuable guidance document, please enroll for this webinar by visiting signs the FDA form 1572

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There are nine statements in the FDA form 1572. Seven out of these begin with “I agree”. These are the important elements named in the 1572:

  • 21 CFR 50 (Protection of Human Subjects)
  • 21 CFR 56 (Institutional Review Boards)
  • 21 CFR 312 (Investigational New Drug Application/IND)
  • For Device studies, 21 CFR 812 (Investigational Device Exemptions/IDE) is added in place of 21 CFR 312.

The GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811 outline additional responsibilities. It makes sense for PI and sponsors to comply with the principles of Good Clinical Practices (GCP), and to also use their common sense.

Charles will give a proper understanding of all these at this webinar. He will cover the following areas at this webinar:

  • The Investigators role in the clinical research process
  • The difference between AEs and SAEs and the reporting requirements of the investigator
  • Why the investigator maintains a list of staff signatures?
  • Why the investigator files the signed and dated protocol?
  • Why the investigator is responsible for the IC process?
  • What is the legal language of the FDA form 1572 or Device equivalent?
  • Why is Financial Disclosure information important?

What is the history of the drug / device regulations?

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Actions for Noncompliance of cGMPs in the Quality Control Laboratory

Quality controls in laboratories are a major area for which the FDA issues 483’s. A laboratory is the venue for many activities, all of them of varying importance to the product. When controls in laboratories are not up to the standard, such a laboratory could produce products that do not meet quality and processes expectations, and hence invite 483’s.

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Issues with drug quality, drug integrity and data integrity, as well as data fabrication and human errors and even behavior towards the FDA inspectors during inspections are some of the reasons for which laboratories get hauled up by the FDA. The inappropriate or incomplete implementation of cGMPs in the Quality Control labs is a major area for which the FDA takes penal actions against them.

Most common areas of noncompliance

These are some of the most common areas in which the FDA is likely to find issues relating to cGMPs in Quality Control laboratories:

  • Out of Specification lab results
  • Laboratory error- improper analysis method, use of incorrect standards, and/or miscalculation of data
  • Operator error or non-process error
  • Fault in the manufacturing process
  • Product failures
  • Laboratory documentation and records
  • Validation of methods
  • Equipment errors
  • Problems with raw materials
  • Lack of in-process controls and specifications
  • Management of the laboratory
  • Unexplained anomalies

Ways of avoiding penal actions

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From about the 1980’s, the FDA has been targeting Quality Control laboratories ever more stringently. The way of avoiding receipt of 483’s, which could escalate into a Warning Letter if it not addressed properly, is to be aware of all the ways by which to meet the FDA’s requirements of cGMPs in Quality Control laboratories. Some of the steps a QC laboratory needs to take to avoid FDA actions include:

  • Carefully reviewing and analyzing the regulations, inspectional guidance, 483 observations and Warning Letter and internal audit observations and deviations
  • Thoroughly reviewing laboratory practice and procedures
  • Gaining knowledge of the areas the investigators review and the type of observations that are made in other organizations and using this information to ensure that their laboratory operations are improved

Implementing actions based on these is at the root of its strategy for avoiding future observations of non-compliance and the issuance of 483’s from the FDA.

A valuable learning session on implementing these

How do laboratories do all these? How do they implement the correct cGMPs in their Quality Control laboratories, so that they meet the FDA’s compliance requirements? A webinar on this highly relevant and meaningful topic from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show how.

John Lanese, an independent consultant with a focus on Quality Systems and the components of an effective Quality System and Founder of The Lanese Group, which consults with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations; will be the speaker.

Please register for this highly valuable session by visiting and learn all that it takes to implement cGMPs in the Quality Control lab and avoid harsh penalties from the FDA, which could set your business back.

A thorough approach to imparting lessons on cGMPs

This is the approach that John will adapt for inculcating the lessons on cGMPs in the Quality Control laboratory:

He will apply one aspect of a proactive approach and review how this approach can be implemented for meeting regulatory requirements. He will then analyze 483 and Warning Letter observations to determine if similar observations that could serve as a benchmark to initiate further preventive actions could be made in the participants’ facility.

John will explain the non-conformances most often cited by the FDA, along with the relevant regulation. He will then show specific observations that relate to the laboratory cited in Warning Letters and FDA 483s. John will use these real life examples to show to participants the ways of analyzing what went wrong. He will explain the systems, procedures and records the laboratory should have in place that would prevent a similar observation. He will also familiarize the participants with several questions that a laboratory manager or an auditor might ask to assure that appropriate systems, procedures and records are in place and are being followed.

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Key personnel in laboratories, such as Quality Control Laboratory Managers, Quality Control Laboratory Supervisors, Quality Control Analysts, Quality Control Microbiologists, Quality Assurance Managers, and Quality Auditors will gain immense benefits by participating in this webinar. They will be able to critically evaluate key areas in the laboratory operations for compliance and identify areas for improvement after completion of this webinar.

John will cover the following areas at this webinar:

  • System Based Inspection Guidance
  • Laboratory Control System
  • Most common observations in the laboratory
  • 483 and Warning letter observations
  • Analysis of observations
  • Areas for preventive action.

How to Comply and how to Protect Privacy

The General Data Protection Regulation (GDPR) –codified as Regulation (EU) 2016/679 – is an important law concerning the protection of data of all people living in the European Union (EU). Through the GDPR regulation; all the legislative and secretarial bodies of the EU, namely the European Parliament, the Council of the European Union and the European Commission, fortify and toughen and unify all aspects of data protection for all individuals within the European Union (EU).

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Another area that is addressed by the GDPR is the export of personal data to regions outside the EU. The core purposes for which the GDPR is enacted are twofold:

  • Giving control back to citizens and residents over their personal data
  • Simplifying the regulatory environment and bringing about uniformity and unity in data protection regulations across the EU to facilitate the ease of doing global business within the EU.

The GDPR will be the new law without requiring members to endorse it

The GDPR came into effect when the European Commission adapted the proposal for its creation on January 25, 2012. When the GDPR comes into effect and becomes enforceable from 25 May 2018 after a two-year transition period after being adopted on 27 April 2016; it will replace the data protection directive that has been in use in the EU from 1995: Directive 95/46/EC.

The all-powerful nature of this regulation can be gauged from the fact that it does not require legislative support from any of the EU members. It straightaway becomes law and will be directly binding and applicable from the date of its enforcement.

Benefits of the new legislation

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The GDPR will come with many advantages:

  • It will offer greater and clearer insight into Personally Identifiable Information (PII) processing within the company
  • It will boost security controls and unify these across the 27 EU members
  • It brings about increased customer confidence, since there are stronger safeguards for data protection
  • It will relax the process of doing business in the EU

Drawbacks of the GDPR for companies that want to do business in the EU

While the primary objective of the GDPR is smoothing the laws for allowing global businesses in the bloc; it comes at a rather expensive price tag: If companies fail to comply with the GDPR provisions on data protection, they end up coughing up two percent of their worldwide revenues in penalties!

These are some of the other pain areas of the GDPR:

  • Provisions stipulate fines of up to € 20 million
  • Inviting a host of complicated lawsuits
  • Loss of reputation
  • A host of liability cases

These facts about the GDPR make it necessary for companies in any line of business that want to gain access to the huge EU market to get a complete and clear grasp of the nuances of this new legislation. This is absolutely necessary if they have to avoid the consequences of noncompliance.

Get to understand the ways of the GDPR

This is the learning that a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering. Derk Yntema, who has over 15 years of experience in ICT and security-management and has demonstrated capacity to implement innovative security programs that drive awareness towards information security and strengthen organizations and proven knowledge of privacy legislation and helping companies towards privacy compliance, will be the speaker at this session.

To get a full and proper understanding of the GDPR and how it affects your business, please register for this webinar by visiting Security Controls up to level

At this webinar, which will be of very high value to professionals such as Board of Directors, Supervisory Board, CxO’s and Compliance Managers/Officers; Derk will cover the following areas:

  • What is Privacy?
  • How to Protect Privacy
  • What is PII?
  • What is in the GDPR (General Data Protection Regulation)
  • How to Comply.

Guarding against cyberattacks

Data breaches, malware and related frauds can cost an organization very dearly. The effects of cyber fraud are rather alarming:

It was estimated that cyberattacks amounted to a loss of at least a trillion dollars to the US economy in 2013, up by more than 25% over the previous year. The US continues to be the largest target and sufferer of cyberattacks. It accounts for more than a third of all cyberattacks that happen all around the world, followed by India, which is a distant second, at a ninth of that of the US.

Security

In terms of numbers of cyber attackers, the top cyber attackers are found predominantly in the developed world, with three of the top countries for cyber attackers belonging to the west. Germany is home to over a million cyber attackers, followed closely by the US, which had close to a million attackers in late 2013, followed by Mongolia and France.

 

A huge variety of losses

In addition to the financial loss that organizations face in the aftermath of a cyberattack, they have to also contend with other losses that are of a grave nature. Organizations in which fraud happens risk their reputation. They go down in the market as being run by incompetent and untrustworthy people at the top. Deloitte lists a number of other losses, both hidden and overt, that cyberattacks cause to organizations. These are some of them:

  • Inability to meet regulatory compliance and having to pay fines levied by regulatory agencies
  • Payment of losses and fees spent on litigation
  • Costs relating to taking measures to improve security
  • Cost of the investigation
  • Loss caused by disruption to business
  • Loss of intellectual property
  • Increased cost of insurance

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What can be done about this?

If organizations need to prevent negative scenarios such as these; they have to implement a number of security measures and procedures. These security measures need to be in the form of an Incident Response Program that will allow organizations the ability to respond to such attacks with dexterity, while at the same time making sure that their business operations do not get disrupted.

This calls for establishing Key Performance Indicators (KPI) to help to determine if organizations’ Information Systems Incident Response program meets business objectives and operational metrics for ongoing process improvement.

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Get to understand the ways of implementing cyber security

The ways of putting such a system in place will be the learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. Michael Redmond Consultant, a well-known speaker and author who also conducts ISO Certification Training for PECB, will be the speaker at this webinar. Michael is the Chapter President for Association of Contingency Planners Eastern Great Lake Chapter and an active member of ISSA.

Please log in to Business Continuity Planning to register for this webinar.

The key learning imparted by this training session is the ways of creating, testing and implementing an effective cyber Incident program to counter cyber threat and malware attacks. It will explain how to measure an organization’s susceptibility to a cyberattack. The speaker will explain the critical action areas in such events.

Ms. Redmond will explain all the measures that organizations need to take in order to avert a cyberattack, during the course of which she will discuss the following:

  • How to tailor and enhance an existing security training program and set up requirements for specific audiences
  • How to strengthen IT Risk Management – Integrate Information Security risk management with enterprise risk management
  • How to build an IS regulation review process, schedule and regulation requirements

This session will be of high value to those professionals who are at the forefront of security operations, such as Information Security Managers, CEO, CIO, CFO, CSO, Technology Managers, Risk Managers, Compliance Managers, and Auditors.

The speaker will cover the following areas at this webinar:

  • Adopting a systematic approach to risk tracking to enhance the effectiveness of the Cyber Incident Program
  • Outlining the critical actions to take if an event affects the company or its partners
  • Understanding an organizations’ susceptibility to a Cyber Attack
  • Cyber Incident Response: Getting started, research, training, testing and maintaining
  • Standards and Best Practice: ISO 27001, ISO 27035, ISO 27005. NIST, FFIEC, HIPPA and HITRUST.

Learn how to build professional, eye-catching form-driven applications and spreadsheets

MS Excel, a wonder program, has umpteen uses for a number of professionals, students, and a host of other users. We have known for long that it can be used to carry out a number of functions that are varied and interesting. However, adding design elements to MS Excel goes a long way in enhancing its aesthetic appeal, as also the effectiveness.

Booking forms, sales order forms, invoices, loan agreement forms and surveys are just some of the endless kinds of forms that can be created using Excel. These can be made a lot more attractive and likeable by just adding a touch of features such as color, cell protection and some drop-down lists and simple validation.

A few simple steps at design

Just a few splashes here and there into these forms, and you will be amazed at the extent to which these bland forms can transform themselves into user-friendly ones that will make data entry simple and error free for everyone concerned, be it the user, her colleagues, or her clients. Small techniques such as this will eliminate the hassle of having to go through the long-winded, repetitive and frustrating experience of entering and editing data into a table in Excel.

This is just one of the many tricks that will be taught at a webinar on adding design elements into MS Excel to make it more illustrative, attractive and useful. At this webinar, the Expert, Mike Thomas, the globally acclaimed guru of MS Office, who has spent over a quarter of a century as a subject matter expert in a swathe of subjects relating to MS Office and Mac, will be the speaker.

Loads of experience

The experience and wisdom that Mike has gained over these years, during which he has been Fellow of The Learning and Performance Institute and has worked with and for a large number of global and UK-based companies and organizations across a diverse range of sectors, will be in full flow at this highly interactive webinar session. Want to know how to optimize the use of design elements into MS Excel to make it more palatable and likeable? Just log on to http://www.compliance4all.com/control/w_product/~product_id=501316LIVE?Wordpress-SEO to enroll and relive the fun of learning about MS Excel.

Adding design elements into MS Excel to save costs and time

The main benefit that people across a spectrum of professions and activities, such as Business Professionals, Business Owners, Researchers, Administration Support Staff Educators, or for that matter anyone who wants to learn how to get the best from MS Excel to manage projects and their life, will gain from this webinar is that they can save the invaluable resources of time and money by learning to enhance the use of forms in MS Excel.

This session is highly useful to smaller organizations that are constrained with limited budgets and will think twice when needed to buy expensive dedicated software to manage the inputting and storage of information. This of course, does not preclude bigger companies from this learning.

Using other MS Excel features to create forms

The speaker will enable participants to follow real-world examples to learn how to build professional, eye-catching form-driven applications and spreadsheets. Since there is no option for creating a form; Mike Thomas will teach participants how to use a number of other built-in MS Excel features to create forms and then subsequently make them attractive with its design.

Mike will cover the following areas at this webinar:

o  Naming cells-to make formulas easier to understand

o  Drop-down menus and checkboxes-to make data entry easy

o  Data validation and protection-to reduce the risk of data-entry errors

o  Formatting-to make your forms inviting to use

o  Formulas and functions as VLOOKUP

o  Simple automation.

Which Excel feature allows you to identify unlocked cells into which data can be entered

Mastering spreadsheet internal controls in MS Excel is a great way to make the most out of MS Excel. Unlocking these internal control features in MS Excel makes the program more efficient and powerful, and helps users derive more value out of its various applications.

Even though professionals in various areas, such as Accountants, CPA’s, CFO’s, Controllers, Excel users, Income Tax Preparers, Enrolled Agents, Financial Consultants, IT Professionals, auditors, human resource personnel, bookkeepers, marketers and government personnel, use MS Excel extensively in the course of their day-to-day work; they can still learn to improve and optimize the uses from MS Excel by learning more about it.

Learn the secrets of the power of MS Excel

This is what a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer at a highly interesting and educative webinar. This webinar will have David Ringstrom, an author and nationally recognized instructor who teaches scores of webinars each year, as speaker.

David’s Excel courses are based on over 25 years of consulting and teaching experience. He believes in the mantra: “either you work Excel, or it works you”. This is why he focuses on what he sees users don’t, but should, know about Microsoft Excel. His goal is to empower participants to use Excel more effectively.

It is this zeal the speaker carries into his teaching of MS Excel that will come into full play at this webinar. Interested in gaining from the wealth of experience that David brings into MS Excel? Then, just visit http://www.compliance4all.com/control/w_product/~product_id=501293LIVE?Wordpress-SEO to enroll.

Teaching from a simple standpoint

At this presentation, David Ringstrom will use a simple invoice form as a teaching aid to present various ways to control users’ actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes. What makes this presentation different is that the presenter will demonstrate every technique at least twice: first, on a PowerPoint slide with numbered steps, and second, in Excel 2016.

He will explain the differences in Excel 2013, 2010, or 2007 both during the presentation as well as in his detailed handouts. David will also give participants an Excel workbook that will include nearly all the examples he will be using during the webinar.

David will help participants with the following:

o  Discover how to use lookup formulas to find and access data automatically from lists

o  Apply Excel’s Table feature to future-proof elements of your spreadsheet.

o  Define how to use Excel’s Data Validation feature to restrict data entry to a list of permissible choices

o  Learn a custom shortcut for toggling the Locked status of a worksheet cell on or off

o  Understand how to preserve key formulas

o  Learn which Excel feature allows you to identify unlocked cells into which data can be entered

o  Learn a variety of ways to control users’ actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes.

David will cover the following areas at this webinar:

o  Using Conditional Formatting to identify unlocked cells into which data can be entered

o  Utilizing Data Validation to limit percentages entered in a cell to a specific range of values

o  Improving the integrity of spreadsheets with Excel’s VLOOKUP function

o  Toggling the Locked status of a worksheet cell on or off by way of a custom shortcut

o  Future-proofing VLOOKUP by using Excel’s Table feature versus referencing static ranges

o  Preserving key formulas using hide and protect features

o  Making it harder for a user to circumvent data validation and easy for you to identify when someone has attempted to do so.

Challenges to analyzing financial statements

Analysis of financial statements, or Financial Statement Analysis or FSA, as the discipline is called, is the application of one’s analytical ability into understanding the financial statements of a company. This analysis is made to get insights into how the company has been performing financially over a defined period of time. Based on this understanding, financial analysts make forecasts of how the company is expected to perform in the future, based on certain parameters.

Financial experts get down to understanding the way in which one of the company’s most vital ingredients, finance, is performing. FSAs are the most truthful indication of not just how the company has been performing, but also how its performance is going to lead the company in the future. Being an important tool in analyzing the financial health of the company; FSAs reflect the financial state of the company. These statements help the management decide on the company’s future decision-making relating to investment.

Viewed by many stakeholders

Financial statements are critical statements from a company. They are viewed and analyzed by a number of internal and external sources. While the company’s board of directors, management, and employees belong to the group of people who analyze FSA’s internally; customers, shareholders, banks, lending institutions, the general public and the government are some of the external analysts of FSAs.

Financial experts analyze FSAs in two important manners: Horizontal and Vertical. At their barest, horizontal analysis represents the history of the company’s financial performance over a varied period of time, while vertical analysis is made of a fixed period of time.

Types of Financial Statement Analysis 

Ratio analysis

Ratio analysis is one of the important techniques of Financial Statement Analysis. It is the analysis of how the company has performed in core areas of its business.

DuPont analysis

Another important analysis tool of Financial Statement Analysis is what is called DuPont analysis. It extends the ratio analysis method by taking note of the areas of strengths and weaknesses in the company’s financial statements. It breaks up the aspects of the company’s financial statements into the sources, such as equity, investments or others, from which the company is earning its revenues.

Challenges in Financial Statement Analysis

Financial Statement Analysis comes with its challenges. Financial Statement Analysis works in a vacuum. There is no theory or point of reference to which the Financial Statement Analysis is made. It is based purely on each situation, and is thus vulnerable to extreme volatility in the analysis. The fact that a company’s Financial Statement Analysis is positive in a certain situation under certain factors is no indication of how it would be in the future, in different situations. There are too many large variables involved in Financial Statement Analysis.

When a company is operating a number of businesses; it is difficult to evaluate the performance of each of the businesses, especially if the businesses are diverse. There are no fixed parameters to judge the performance of each of them.

Also, when accounting practices change; the whole character of Financial Statement Analysis undergoes a metamorphosis. This makes it necessary to completely redraw the practice of Financial Statement Analysis.

Financial Statement Analysis is not always accurate in analyzing the strengths or weaknesses of many of the company’s intangible resources.

Get to understand the ways in which Financial Statement Analysis works

A complete understanding of Financial Statement Analysis, with a clear definition of the challenges involved in this practice, will be given at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. At this webinar, Kevin Chenoweth, who has expertise in designing project plans for multi-million dollar Oracle R12 financial leading to under budget and on-schedule projects, will be the speaker.

To get insights into the challenges involved in Financial Statement Analysis; please enroll for this webinar by visiting Financial Statements & Valuation

Kevin Chenoweth will cover both the telecommunication and technology industries at this session, and will show how company operations can be improved. He will also offer recommendations on trend and ratio analysis as applicable to diversified industries. He will also help participants evaluate sales trends and develop ways to increase sales.

He will deconstruct financial statements and help identify key drivers of organic and inorganic growth. This session is of high value to those involved in Financial Statement Analysis, such as Accounting Staff, Finance Staff, IT Staff, Sales & Development Staff, Business Directors, Auditors, Company/Business Owners, and Finance Managers.

The following areas will be covered at this webinar:

o  DuPont Analysis

o  Cash to Cash Cycle

o  Real Options for Decision Making

o  Understanding organic and inorganic growth

o  Ratio and Trend Analysis

o  Quantitative and Qualitative Analysis.