An effective internal audit program is indispensable for continuous improvement

Both the ISO and the FDA require an internal audit program of an organization’s Quality Management Systems. This is a core requirement. The simplest way to understand an internal audit system is that it is a tool to assess or inspect an organization’s Quality System.

Apart from helping organizations to fulfill the requirements of auditing set out by the ISO and the FDA and other regulatory bodies, audits, be they internal or external; carry manifold advantages. These are some of them:

o  Organizations can apply best practices relevant to their industry through audits

o  Audits help organizations to identify where they need to improve

o  Audits play a stellar role in ensuring the quality of products, which leads to enhance customer satisfaction

o  They help organizations to take preventive actions with which bigger problems can be checked

Most organizations think of audits as an unpleasant duty

Although internal and external audits are considered so useful; it is a fact that most organizations carry them out only because it is thrust upon them. Most companies lack the conviction and volition for an audit, and drag their feet when it comes to this important task. The many benefits of an audit program are usually overlooked by 75% of companies.

What happens to organizations that are not diligent when it comes to carrying out audits? They are sure to receive penal actions from the FDA, which range from Warning Letters, 483’s to penalties to Consent Decree.

Learning session on ways of getting internal audits right

In order to help organizations get their internal and external audits right, Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar. The purpose of this session is to help professionals who need to carry out an internal audit for their organization, get it right.

The speaker at this seminar is Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc., who is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. Participants that want to get a clear and total understanding of the rationale for carrying out audits and of the ways for get them right can enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501303LIVE?Wordpress-SEO

An explanation of the ins and outs of auditing

Susanne will equip participants with the knowledge needed for audit professionals in organizations to put an effective and compliant audit program in place. She will help them understand what it takes to carry out a solid and thorough quality audit program that meets regulatory requirements by first being able to identify the red flags. This is the groundwork for understanding, reducing and communicating risks associated with quality and compliance.

Susanne will cover the following areas at this session:

o  Using a structured program to identify areas of risk leading to an effective audit strategy

o  How to develop a meaningful structure of audit, oversight, transparent communication, and escalation to management review

o  How to ensure your audit staff is well trained to proactively identify, communicate, and escalate issues

o  How a culture of quality and compliance can encourage clear and transparent communication of risk

o  How to prioritize, resource, and implement corrective actions

o  Tools for monitoring and communicating risk and improvement over time

o  How to identify residual risk

o  Monitoring and Controlling progress over time

o  Signs that your company culture is taking unnecessary compliance or quality risk

o  How to ensure management gets valuable information from your audit program

o  How to prioritize, resource, and implement corrective actions

o  Tools for monitoring and communicating risk and improvement over time.

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.

Webinar Calendar of Upcoming Courses – May to Jun 2017

webinar-training-online-education.jpgBelow is the event description content:

Compliance4All webinars are just what professionals in the regulatory

compliance areas need for scaling up in their careers. With a collection of

the most erudite experts on regulatory compliance being available at a click

in the comfort of your preferred location; regulatory compliance could not

get any simpler and effective!
Compliance4All’s experts help you unravel all the knowledge you need in all

the areas of regulatory compliance. They help professionals like you

implement the regulations and stay updated, so that regulatory compliance

causes no stress for you. Compliance4All’s experts offer their insightful

analysis into the issues that are of consequence to regulatory professionals

in their daily work. Their thoughts help you implement the best practices of

the industry into your work. They also offer updates on the latest regulatory

requirements arising out of a host of the laws and issues related to

regulatory compliance, such as Pharmaceuticals, Biologics, Healthcare, Food

and Beverages, Software, Embedded Technologies, Energy and Utility,

Payment Card Industry (PCI), and lots more.
Take a look at our upcoming webinars from Compliance4All, which will put

you on the road to learning about any area that is of importance to your

profession. You can plan your learning from Compliance4All by looking at

our events in the next few weeks. You can choose from a whole range of

topics. See which among these trainings suit you: FDA Regulation of

Medical Device Software, Conducting Successful Product Complaint

Investigations, CAPA, Failure Investigation and Root Cause Analysis, 1099

and W-9 Update, Laboratory-Developed Tests, avoiding an FDA 483,

Equipment Validation, and much more!

For more Calendar Webinars http://www.compliance4all.com/control/webinars_home

The art of writing effective audit observations

Audits are a means of evaluating operations and other functions of an organization. ISO 19011:2011 Guidelines for Auditing Management Systems describes audits as a process used for gathering the evidence of verifiable documents and map their suitability, alignment and fulfilment with the company’s policies and procedures.

An audit is an important tool that helps organizations to analyze opportunities, implement best practices, and assess all the important factors in a business, such as risks, ethics, controls and quality. Conveying these to the management is the primary aim of an audit.

An audit is indispensable for mitigating risks and ensuring governance. An audit can be either:

o  Internal, where an organization’s employees in charge of audits in an organization in charge of audits carry out audits, or

o  External, where an external, independent auditing professional examines and evaluates the company’s functions objectively.

Each of these two types of audits is important. Either of these may be required, or both may be required, depending on the kind of business and practices an organization has.

Broadly, these are the types of audits:

Financial audits: Financial audits, as the name suggests, are related to how an organization keeps financial controls in place and report them to the authorities. Financial audits are summed up in financial statements, which spell out the extent to and the ways by which financial aspects of organizations tally.

Operational audits: These are the audit or assessment and evaluation of how an organization actually carries out its business. Being of this nature; operational audits are concerned primarily with business processes. The aim of operational audits is to suggest ways by which organizations can improve their operations to optimize their businesses and increase ROI.

Compliance audits: These are carried out to ensure the compliance with regulatory requirements in an organization. A number of these regulations need to be complied with depending on the nature and location of business.

Information Systems: Since no organization can stay aloof from automation and since information systems are required for almost all functions in an organization; it needs to systematically and thoroughly review its information systems from time to time. An effective information systems audit takes not only existing, but also emerging technologies into consideration and suggests ways by which to improve its network and firewall its data security.

Integrated Audits: Suggestive of its name; an integrated audit is one that assesses, monitors and controls all the kinds of audits –Financial, Operational, Compliance, and information systems risks. Auditing professionals locate these integrated audits on a business process or cycle or part of it.

Understanding and carrying out operational audits

Operational audits, being among the important kinds of audits, are governed by their own set of standards. They have their own set of standards that need to be complied with. These are set out by The Institute of Internal Auditors (IIA). And, like other types of audits, operational audits require a high degree of knowledge, diligence and skill.

The ways and means of carrying out operational audits can be complex and requires adherence to a number of standards and best practices. Auditors need to be thorough in their understanding of how to do these in an optimized fashion and ensure results for the organization.

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be providing this insight at a highly educative webinar. Jonnie T. Keith, who has over 40 years of audit experience and has served as the Chief Audit Executive for the Metropolitan Atlanta Rapid Transit Authority (MARTA) for the past 10 years, will be the speaker at this webinar.

To enroll for this session and to gain from the expertise Jonnie brings into auditing, please visit http://www.compliance4all.com/control/w_product/~product_id=501309LIVE?Linkedin-SEO

A complete roundup of operational audits and the ways of writing audit observations effectively

At this webinar, Jonnie will explain the intricacies of an operational audit. Jonnie will explain the importance and ways of writing these audit observations effectively and compellingly. He will explain the concept and all the important aspects that go into operational audits, such as management responsibilities and the key IIA standards that go into audits and the areas of their purview, such as the following:

2010 – Planning

2201 – Planning Considerations

2220 – Engagement Scope

2240 – Engagement Work Program

2300 – Performing the Engagement

2400 – Communicating Results

2500 – Monitoring Progress

http://asq.org/learn-about-quality/auditing/

https://finance.columbia.edu/content/types-audits

http://www.accountingtools.com/operational-audit

https://na.theiia.org/about-us/about-ia/Pages/About-the-Profession.aspx

Writing error-free procedures while complying with GMP regulations

In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.

Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major culprit when it comes to losses that many industries sustain in their quality and production. Technology has pervaded most industries in ways that were not imaginable a couple of decades back; yet, it is not likely that human error will ever be totally eliminated.

error-metaphor-teamwork-concept-separated-white-31189596

Having said this, it is also true that it is possible to prevent several human performance problems. The starting point of human errors start is the design stage. Human reliability comes into play in a major way in procedures. The key to human engineering, improving and/or fixing and identifying exactly where the weaknesses in the procedures instructions lie is getting a grasp of human behavior and the psychology of error.

A learning session on all the aspects of writing for GMP regulations

An understanding of the weakness in procedures that harm productivity, quality and regulatory standing will be the major learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Ginette Collazo, a human error and human behavior expert, who brings vast experience in the technical training, organizational development and human reliability areas. Interested in gaining insights into how to understand and reduce human errors in GMP procedures? Then, all that you need to do is to register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501285LIVE?Linkedin-SEO

Discussion of all the areas of human error in writing for GMP regulations

At this webinar, Ginette will discuss everything from content development to formats designed for human error reduction due to procedures. She will start with an outline of SOP writing and describe the role and possibility of human error in content development. She will also discuss the universal purpose of procedures in the background of regulatory compliance.

Ginette will expound the human perspective and the rational for procedure use and describe human error as a root cause. She will also explain the thinking and reading process and touch upon some common mistakes and causes.

Human error rates and measurement, the ways of creating and maintaining a procedure, as well as the goals of a procedure, will all be taken up.

Taking a glimpse at Good Procedure Writing practices

Another of the areas Ginette will traverse during the course of this very interesting session is Good Procedure Writing practices, during which she will dwell upon all its related aspects such as Terminology, Formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions”.

Finally, she will also explain procedure styles and the use of electronic information networks for procedure access. All in all, this promises to be a very educative and well-rounded teaching session. All the important people involved in GMP regulation and human factors, such as QA/QC Directors and Managers, Process improvement/excellence Professionals, Training Directors and Managers, those in Plant Engineering, Compliance Officers, Regulatory Professionals, people in Executive Management, Manufacturing operations Directors and Human factors Professionals, will all derive benefits in large measure from this webinar.

Corrective and Preventive Action (CAPA) is vital to the life sciences

Corrective and Preventive Action (CAPA) is of the essence in any industry. The importance of CAPA is all the more pronounced in the life sciences industry, considering the importance of this discipline on human lives. It is the very core of a sound management system. CAPA, as the name suggests, is a set of preventive and corrective measures that need to be taken to ensure that the product meets its quality and regulatory expectations.

The essence of CAPA for the life sciences is that it should build the ability to respond to problems as they arise, but more importantly, a CAPA system should help the life sciences organization to anticipate and thus prevent problems from happening.

CAPA in the life sciences is an amalgamation of the following core ingredients:

o  Change Control

o  Continuous improvement

o  Complaint management

o  The need for understanding and implementing CAPA

CAPA is the very edifice of Quality Management. It is a sine qua non for meeting regulatory requirements. Its importance to the life sciences industry vis-à-vis the FDA can be gauged from the fact that in just four years starting 2012, the number of Warning Letters the FDA issued shot up by over 12 times. Understanding and implementing the right CAPA system is critical to meeting regulatory requirements and preventing such actions from the FDA.

Common pitfalls of CAPA implementation

Many life sciences organizations face a few obstacles when it comes to CAPA implementation. The most common ones among these are:

o  Failure to achieve an integrated view of the whole process that can be managed from any source

o  Lack of understanding of the highly intricate and difficult processes

o  Not documenting every step of the CAPA process

o  Lack of clarity between what a corrective and preventive action is

o  Not implementing uniform process across the product’s or company’s numerous sites.

An important line of thinking that needs to go into approaching CAPA is that understanding failures is as important as understanding success of a product in the life sciences industry if it has to meet quality and regulatory requirements. Understanding and correcting problems before they become critical and impede the product’s progress are vital to ensuring quality and meeting regulatory requirements.

Given the extremely high importance CAPA has in the regulated industries; it is but natural that there are a number of regulations that govern this area of the life sciences. How does an organization get an understanding of these regulations right? How does it enforce these regulations in the right manner, so that its products meet the regulatory and quality requirements?

Learn to get these aspects right

All these will be the topic of a highly valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm, will be the speaker. To gain proper and complete insights into all the areas of CAPA for the life sciences, just register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501216?Wordpress-SEO

At this session, Charles will explain how to apply core aspects of the CAPA process that includes:

o  The critical steps

o  The timing of CAPA

o  Who all in the organization need to take part in the process

o  Their roles, responsibilities and functions, and

o  The snags and hazards with CAPA investigation into the process.

The content of this webinar is designed to help participants achieve a highly effective CAPA system. It will help explain the purpose and function of CAPA, by which they will be able to:

o  Identify and explain the relevant CAPA regulations

o  Define exception/deviation reporting and explain the process of executing the reporting process

o  Explain and trace the CAPA flow from problem identification to resolution

o  Explain the challenges and pitfalls of the CAPA process and how they are overcome.

o  Explain CAPA’s role in risk mitigation.

o  Explain how root cause analysis is executed.

At this very valuable session, Charles will cover the following areas of CAPA for the life sciences:

o  CAPA defined

o  CAPA relevant regulations

o  Exception/deviation reporting

o  CAPA process flow

o  CAPA process steps explained

o  Challenges and pitfalls of CAPA’s

o  CAPA and risk mitigation

o  Root Cause Analysis.

http://www.meritsolutions.com/life-sciences/top-8-pitfalls-and-challenges-of-life-sciences-capa-systems-and-processes/