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.

Paper records to electronic for pharmaceutical companies

Following the rapid advances being made in the field of information management in the past quarter of a century or so, computers have increasingly come to replace paper as the source in which important documents are created and stored. Till the last decade of the previous century, organizations used paper to record and document information relating to their research, development and business. From around the start of the 1990’s; the shift towards computerization of paper records has been noticeable.

Many differences between paper and electronic records

One of the defining differences between this electronic standard and traditional paper records is that while the latter used to be stored in a central, protected environment and managed by a designated managers; electronic records are spread over many locations.

Although some are managed by a central authority; most are under the control of individuals. Individuals in charge of this work have a wide range of computer based devices such as phones, laptops, tablets and USB storage devices at their disposal, which can be used for functions such as authoring, storing, and copying and transmitting relevant information.

Also, the information available on these systems can be stored and shared within several locations on the web, with the option of protecting some better than others. What has also changed substantially is the process of verifying the authenticity of a record. Earlier, the method used to authenticate paper records was via inked signatures of the author and witness. Encrypted e-signatures are replacing this practice.

Submissions to the regulatory authorities

In line with this development, the FDA and other global regulatory agencies started accepting electronic files, or at least parts of submissions, for testing and marketing drugs. This movement, which started in the early 1990’s, led to the creation of the Common Technical Document (eCTD) standard. This standard is now required in the US and most countries around the world.

If pharmaceutical and life sciences companies have to submit documents such as the NDA, ANDA, IND, BLA, DMF and the BMF to the FDA electronically, the eCTD has been the pan-industry, widely accepted standard since 2008. Submissions are, in fact, no longer done via paper records. If companies have to incorporate legacy paper records into an eCTD; they have to scan those and put them into a text readable format.

A source of important information

Despite the existence of this method; many companies continue to possess huge troves of paper based information, which are yet to enter the cyber realm. These records contain important information relating to the pre-clinical, clinical and drug safety paper records of drugs that did not make it to the marketing stage for a variety of reasons, because of which these companies have archived this information.

This archived data, if harnessed effectively, could be a rich source for offering knowledge that will go on to enhance inputs for submissions for other new or emerging indications for the drug or support efficacy or safety for related drugs. Many organizations have a large collection of paper records with retention times of 50 years or more. There is a dilemma of how to best preserve and utilize these records.

What is the way of going about for transiting?

Many companies are in a quandary about what to do in a situation in which the majority of records are electronic, but a substantial number remain as aging paper records. If the wealth of information available in paper format is to be exploited meaningfully, should they convert all the paper records to an electronic format, convert some of them, or just leave them in their current form? Given that complete conversion and subsequent integration is a very expensive and laborious exercise; a better option will be to convert on an as-needed basis.

The ways of how to do this effectively will be the topic of a highly educative webinar from Compliance4All, a provider of professional trainings for all the areas of regulatory compliance. At this webinar, Dr. Charlie Sodano, an experienced, globally recognized information management professional who launched eOrganizedWorld a consulting firm specializing in the planning and implementation of records and information management systems, will be the speaker.

To understand and have these issues resolved from the expert, please register for this webinar by logging on to Records policy and procedures

Dr. Sodano will take up and explain the issues relating to conversion of paper records into electronic, and the ways in which the submissions need to be made. This training is of importance to professionals in Research & Development, Regulatory, Clinical, Legal, Information Technology and Validation.

During the course of this session, Dr. Sodano will cover the following areas:

o  Records policy and procedures

o  Records data map

o  Incorporating paper records into a eCTD

o  Converting paper documents into a useful electronic format

o  Scanning costs and resources

o  Indexing and organizing scanned records and integrating them

o  Long term record storage and retrieval.

All about human error and ways of reducing it

There is the saying that after all is said and done, to err is human. In a philosophical sense, it can have numerous interpretations, but in the field of Good Manufacturing Practice, it cannot be taken with a pinch of fatalism. GMP requires everything to be precise and scientific to a T. GMP is not an area that leaves anything to human error. Being an area of science, GMP has no place for imagination and chance.

This is why human errors should be taken note of very seriously when it comes to GMP. Human error is seen as a major cause of most losses caused to many organizations. Whether these human errors are intended or not is a matter worth debating on another occasion. But for the purpose of this discussion, quality is something that can severely get dented with human error.

Human error is known to be the culprit and the cause of many losses relating to quality and production. It is at the root of many performance issues. It is highly unlikely that even with our use of many precise scientific tools and devices, human error will totally be eliminated. It is accepted that human error can only be mitigated and minimized.

Understand the source first

So, if human error is something that is known to be part of our lives, it is worth exploring what needs to be done to contain it. The first step is to identify the source of human error. Human error starts right at the design stage. The prudent approach is to thoroughly understand the root cause and reduce the likelihood of human error by going deep into the variables and causes that bring about human error.

This involves having to manipulate the procedures, training, and workplace environment where many variables that affect human behavior intersect. In order to understand the cause and nature of human error, one needs to directly address the systemic weaknesses in order to improve or fix them. To do this, it is necessary to get an understanding of human behavior and the psychology of error.

Get professional trainings to explore human error in depth

Want to understand how to reduce and keep down human error in quality and production? Then, a webinar from Compliance4All, a highly acclaimed provider of professional trainings for all the areas of regulatory compliance is what you need. This webinar is being organized to help regulatory and quality professionals get a thorough feel of the factors that cause human error.

Ginette Collazo, a human error and human behavior expert who has spent more than 15 years in technical training, organizational development and human reliability areas, will be the speaker at this webinar.

 

 

 

Just visit http://www.compliance4all.com/control/w_product/~product_id=501286LIVE?Linkedin-SEO to register for this highly interesting and valuable webinar.

Practical approaches to all areas of human error

Ginette will offer practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology for the correction and prevention of these issues and to help avoid their recurrence.

This webinar will cover all the important areas of human error. The speaker will help the participants understand the factors and causes of human error. She will help them explore the importance of human error from the regulatory and business perspectives. She will define the process of managing human error deviations.

Another important learning objective of this webinar is human error measurement and the tools for measurement. Ginette will also help the participants to establish Key Performance Indicators and help them understand how to define and measure human error rate, cognitive load, and CAPA effectiveness. She will also help them identify what they can do in their personal capacities to support human reliability.

Procurement and Contract Fraud is usually off -the books- and difficult to detect and investigate

In this interconnected, interdependent global world, the need for contracting procurement of any goods or services is strong and indispensable. However, the benefits of this feature notwithstanding, there are several loopholes in the procurement and contracting activity. Outsourcing and contracting, by their very nature, are vulnerable to fraud. Fraud can happen at any stage of the procurement and contract process.

Common sources of procurement and contract frauds

A very common reason for procurement and contract frauds is when vendors and contractors collude with employees that are in charge of purchasing and administrating contracts. Another source of these procurement and contract frauds is the employee on whose request goods or services are purchased. Yet other procurement and contract frauds happen when solicited contractors work hand in glove with the bidding contractors. The Association of Certified Fraud Examiners (ACFE) estimates that as much as five percent of a business’ revenue is lost to procurement and contract frauds.

Since most of these procurement and contract frauds are based on off-the-books records, they go unnoticed for a good part, despite the fact that governments the world over have deployed scores of auditors and investigators with complete oversight of detecting and controlling procurement and contract frauds.

Plugging the loopholes

The many gaps in the contacting and procuring process need to be plugged if procurement and contract frauds have to be prevented. In addition, once these procurement and contract frauds happen, there need to be a few mechanisms to ensure that the procurement and contract frauds investigation is done thoroughly. Only this ensures that procurement and contract frauds do not go on to cause the kind of damage they normally do.

The first step to detecting, preventing and getting procurement and contract frauds right is to gain an understanding of the nature of the fraud. This understanding is the basis to gaining insights on how to deal with procurement and contract frauds. Many small and medium scale businesses suffer from procurement and contract frauds because are ill-equipped to deal with procurement and contract frauds, lacking as they do the knowledge needed to understand the nature of this activity.

A valuable learning session on procurement and contract frauds

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will impart lessons on how to understand deal with procurement and contract frauds. John E. Grimes III, who has over 45 years of law enforcement, criminal investigation, loss prevention, fraud examination experience, and teaching, will be the speaker at this session. In order to gain knowledge of the way in which the system of procurement and contract works and to understand how to prevent frauds, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501272LIVE?Wordpress-SEO Since the foundation to detecting and preventing procurement and contract frauds is a proper understanding of the various procurement and contract fraud hazards and schemes that are responsible for these frauds; John will start with giving offering knowledge of this aspect. He will explain which steps in the procurement chain procurement and contract frauds are most likely to occur.

Best practices for dealing with procurement and contract frauds

John will offer an understanding and awareness of the procurement fraud hazards that businesses or organizations that purchase materials are vulnerable to. He will also equip them with strategies that are aimed at detecting and preventing procurement and contract frauds, which will prevent them from sustaining huge losses. Also offered at this learning session is a set of proven best practices in investigative strategies that helps look into allegations of procurement and contract frauds.

At this highly valuable learning session on procurement and contract frauds, John will cover the following areas:

  • Basic Steps in the Procurement Process
  • Procurement Policies and Procedures
  • Conflict of Interest Policy
  • The various Procurement and Contract Fraud Hazards and what step in the procurement chain they occur.
  • Fraud Hazards in the Requirement Step
  • Conflict of Interest
  • Bribery, Kickbacks
  • Fraud Hazards in the Section Step
  • Bid Manipulation
  • Sole Source Awards
  • Fraud Hazards in the Post Award Step
  • Change Order Fraud
  • Phantom Employees and Equipment
  • Failure to meet Contract Specifications
  • Product Substitution
  • Fraud Hazards in the Payment Step
  • False, Inflated, or duplicate invoices
  • Three Cases Studies involving Conflict of Interest, Bribery, and Kickbacks.
  • Preventing and Detecting Procurement and Contract Fraud
  • Preliminary Steps
  • Pre-Award
  • Post Award
  • Conducting Procurement and Contract Fraud Investigations
  • Remedies

http://www.fraudconference.com/uploadedfiles/fraud_conference/content/course-materials/presentations/22nd/ppt/5a_paul_zikmund.pdf

https://www.cips.org/Documents/Knowledge/Chapter_12_Guile%20Procurement%20Fraud.pdf

http://www.acfe.com/topic.aspx?id=2722

Today’s Pre control and Statistical Process Control (SPC)

Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.

SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that carrying changes out is neither practicable nor useful.

Examples of process changes that SPC helps to detect include trends, shifts and variation. Three items are needed for SPC to meet its goal:

o  A system that measures effectiveness in real-time

o  Tolerance that is practical and is connected to customer keenness and satisfaction

o  A dial indicator that comes with an anticipated response.

All these help SPC to determine whether a process is stable and requires no adjustment, is incapable of performing its functions altogether, or is deviating but capable.

And now, pre-control

Pre-control, on the other hand, inspects the units and adjusts the process and the succeeding sampling procedures assuming where the measurements are placed in relation to the specification limits. The focus of pre-control is individual measurements.

It uses a set of probabilities, based on assumed distributions and the location of the process, to estimate where there is a justification for the process adjustments. Since decisions concerning pre-control are based broadly, i.e., on the area in which the measurements; it obviates the need for charting, as it is very responsive to the process signals right from the start.

SPC or pre-control?

There are arguments for and against the use of SPC and pre-control as an effective means of ensuring that the process is right and that it results in the desired quality for the product.

At a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, the speaker, Jd Marhevko, who has been involved in Operations and Quality/Lean/Six Sigma efforts across a variety of industries for more than 25 years, will explain all the aspects of pre-control. To hear her perspective of pre-control, please register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501074?Linkedin-SEO

What makes this webinar special is that it has consistently ranked in the top 1-5% at previous conferences at more than five venues. It was featured in ASQ QMD’s special edition of the Quality Management Forum’s 2015 Spring edition (ASQ-QM.org). A webinar of this topic was provided in 2015 via the ASQ QMD Linkage Technical Committee to over 1300 respondents through the IMA and ASQ QMD.

Tools needed for pre-control

At this hour-long session, Jd will explain all the elements of pre-control in Quality. she will show to participants the way of drafting and creating a pre-control chart. She will run a process in which to model the next steps and decisions.

The aim of this session is to equip participants with the knowledge needed for reducing the complexity of the system and bringing about an improvement in the effectiveness and efficiency of their Quality Management Systems.

A session packed with interaction and practical application of principles

A major component of this webinar on SPC and pre-control is that Jd will share the result of case studies. The knowledge gained at this webinar can be applied immediately at their work in respect to the following:

–       Measurement System Analysis (MSA): Jd will conduct a high level overview of MSA. This will help the participants get a grasp of the need for putting an effective measuring system in place ahead of implementing pre-control

–       Cpk Overview: To help participants gain baseline capability in advance of implementation of pre-control, a high level Cpk overview will be conducted

–       Normal Distribution: The way in which the cumulative distribution function of the normal distribution is to be used for estimating and establishing the zones on a pre-control chart

–       Pre-Control Chart: Jd will show participants how to apply the concepts listed above with the use of a mock pre-control chart where the process will be demonstrated based on the “go/no go” zones that are established.

At this webinar, Jd will cover the following areas of pre-control:

o  Reduce process complexity and minimize risk

o  Increase affectivity of a Core Tool

o  Increase personnel compliance in proactive process management.

https://www.isixsigma.com/tools-templates/control-charts/using-control-charts-or-pre-control-charts/

http://www.symphonytech.com/articles/pdfs/precontrol.pdf

http://www.winspc.com/what-is-spc/ask-the-expert/400-pre-control-no-substitute-for-statistical-process-control

http://www.qualitymag.com/articles/86794-pre-control-may-be-the-solution

Optimizing the use of Microsoft Outlook

From the time of its introduction by Microsoft in the late 1990’s, Microsoft Outlook has been a standard package for innumerable organizations around the world. Part of the world famous Microsoft Office system, Microsoft Outlook is a very popular personal information manager.

In the two decades of its launch, Microsoft Outlook has undergone various improvements. The additions that are made to it are aimed at improving user experience and adding features that go on to make it more useful for users.

Needs to be put to full use

Despite its being in the market for such a long time, many users do not know the full extent to which Microsoft Outlook can be put. When explored fully, Microsoft Outlook offers a bouquet of features that go beyond just sending and receiving mails and making appointments on the calendar.

The ways of optimizing Microsoft Outlook for office use and making it a more useful personal information manager will be the content of a webinar that is being organized by Compliance4All, a leading provider of very cost-effective professional trainings in all the areas of regulatory compliance.

Understand the ways of optimizing the use of Microsoft Outlook

At this webinar, Mike Thomas, a subject matter expert in a range of technologies including Microsoft Office and Apple Mac, who is a 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 the speaker.

To get a better understanding of how to put your Microsoft Outlook package to much better use, please register for this webinar by logging on to

http://www.compliance4all.com/control/w_product/~product_id=501148LIVE?Wordpress-SEO

Control Microsoft Outlook; don’t let it control you

Mike will offer simple and easy guidance on how to put Microsoft Outlook to far greater use than people are normally used to. Microsoft Outlook. The point about Microsoft Outlook is that if it is put to the right use, it facilitates a number of functions that the user will find thorough useful and beneficial.

If it is not, Microsoft Outlook has the potential to throw the user’s work schedule into disorder, as many of its functions can confuse the user who does not know how to use it to the maximum.

Mike will show participants of this webinar the simple way of controlling Microsoft Outlook, rather than letting Microsoft Outlook control the user. He will cover the following areas at this session:

o  The 4D’s of email management

o  Configure Outlook for distraction free productivity

o  How to use Rules to automate email processing

o  How to use Quick Steps to automate a series of actions

o  The benefits of Tables

o  Creating data visualizations using Shapes and SmartArt

o  Converting emails into Tasks

o  Using Categories to tag emails, calendar items and Tasks

o  Using Views to display information in a way that suits you.