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.

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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/

The importance of Design of Experiments (DoE)

Design of Experiments (DoE) is an important component in many industries. It is a series of tests or runs that is carried out repeatedly and consistently over a period of time, and its outputs or responses, observed. Design of Experiments is very important in industry to help arrive at an understanding of the predictability and reproducibility of an experiment.

Design of Experiments is a very important aspect of the important elements of a product, such as quality, reliability and performance. What Design of Experiments does is that it helps to examine and investigate the inputs that lead to poor quality. This insight leads the entity carrying out the Design of Experiments to use these to improve their quality standards.

 

Ruling out chance

Design of Experiments does not rely on chance or providence to bring about the quality that is required of an experiment. It arrives at the optimal set of procedures that are needed to get the required quality standards after a series of tests and experiments, so that the final result shows in the process that goes into the product.

Fundamentally, Design of Experiments helps to put in place a system of control for a product. All the ingredients that go into the inputs needed for obtaining a product of a defined standard or quality are scientific and precise. This precision and accuracy is arrived at after carrying out as many runs or series of Design of Experiments as needed to finally arrive at it.

An introduction to Design of Experiments

The ways of understanding Design of Experiments and applying their standards into production will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all areas of regulatory compliance. At this webinar, the speaker, William Levinson, an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt, who is the principal of Levinson Productivity Systems, P.C., will explain the fundamentals of Design of Experiments.

To gain a proper understanding of the principles of Design of Experiments and to get a grasp of how to implement this concept into your systems, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501202?Wordpress-SEO

An understanding of the significance level in hypothesis testing

William will make participants understand how to use Design of Experiments to identify and rule out the particular item or input that affects quality. The concept of significance level in hypothesis testing, which will serve as a basis for not only DoE, but also Statistical Process Control and acceptance sampling, will be explained.

A description of the other uses of DoE, such as supporting Corrective and Preventive Action (CAPA) and in process improvement, where it helps to identify and optimize the factors influenced by Critical to Quality (CTQ) characteristic, will be part of the learning that is on offer at this webinar.

 

 

Levinson will cover the following areas at this webinar:

·        Economic benefits of DOE

·        Hypothesis testing: the foundation of DOE, SPC, and acceptance sampling

o  Null and alternate hypothesis

o  Type I or alpha risk of concluding wrongly that the experiment differs from the control (or that a process is out of control, or that an acceptable production lot should be rejected)

o  Type II or beta risk of not detecting a difference between the control and the experiment, not detecting an out of control condition, and accepting a production lot that should be rejected

·        Factors, levels, and interactions

o  Interaction = “the whole is greater or less than the sum of its parts”. One variable at a time experiments cannot detect interactions.

·        Randomization and blocking exclude extraneous variation sources from the experiment.

·        Replication means taking multiple measurements to increase the experiment’s power.

·        Interpret the experiment’s results in terms of the significance level, or quantifiable “reasonable doubt” that the experiment differs from the control.

http://support.minitab.com/en-us/minitab/17/topic-library/modeling-statistics/doe/basics/what-is-a-designed-experiment/

How do laboratories deal with Out of Specification (OOS) results?

Laboratory testing is the soul of the successful operation by a drug maker. It is required as part of current Good Manufacturing Practices (cGMP) regulations to confirm that all the elements that go into a laboratory product, namely raw materials; in-process materials, finished materials, and containers conform to set specifications. When a laboratory test throws up an Out of Specification (OOS), how do laboratories deal with it?

The FDA takes a very serious view of Out of Specification results

The FDA is very stern in dealing with laboratories which come up with Out of Specification results. It inspects laboratory operations very closely, and has clear guidance on how the laboratory investigates Out of Specification and Out-of-Tolerance observation investigations.

cGMP regulation Sec 211.165 specifies that finished Out of Specification products which fail to conform to set specifications, safety standards and other quality standards will be rejected. These cGMP regulations also state that any unexplained deviation from the set specifications of a batch or its contents will be thoroughly investigated if its test results show an Out of Specification result. This is the same rule for both batches that have been distributed into the market, and those that are not.

Steps to deal with Out of Specification results

cGMP regulation makes Out of Specification testing compulsory for the release of a test batch. Whenever an Out of Specification result is confirmed, the batch gets rejected, and if there is ambiguity in the result, then the company’s Quality Assurance (QA) will have to state the reasons for the release and justify it.

Section 501(a) 2 (b) of cGMP guidelines on Out of Specification requires that current Good Manufacturing Practices need to go into the manufacture of both active pharmaceutical ingredient and finished pharmaceuticals. Further, active pharmaceutical ingredients, raw material testing, in-process and stability testing and Process Validation all come under the purview of the cGMP guidelines.

The FDA guidance on Out of Specification covers the following products:

o  Human drugs

o  Biology and biotechnological products

o  Combination products

o  Veterinary drugs

o  Type A medicated articles

o  Transplantation of human tissues

o  Medicated feed

o  Finished products & active pharmaceutical ingredients

o  Dietary supplements

Need for understanding Out of Specification

All the complexity and depth of the issues relating to Out of Specification results need to be fully understood if a laboratory has to meet the required results. Important personnel in laboratories should have complete knowledge of the FDA expectations for Out of Specification results.

They have to use this knowledge to put in place procedures that define a complete, scientifically sound investigation of each Out of Specification and Out-of-Trend laboratory observation and to establish evidence that laboratory personnel are following the procedures.

A complete understanding of Out of Specification results and dealing with them

This will be the content of a training session that is being organized by Compliance4All, a highly popular provider of cost-effective professional trainings for all the areas of regulatory compliance.

At this session, Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker. To understand the concept and workings of Out of Specification results and the ways of dealing with them, register for this webinar by logging on to  http://www.compliance4all.com/control/w_product/~product_id=501214?Wordpress-SEO

Tools that help deal with Out of Specification results

At this webinar, Jerry will help participants build the foundation for the implementation of adequate procedures that help avoid Out of Specification results, and will review existing procedures and practices. This webinar is aimed at helping participants develop an understanding of the steps a compliant laboratory needs to take to handle the investigation of Out of Specification test results.

Jerry will also explain the ways in which the laboratory has to interface with other units through the laboratory investigation process. The FDA guidance on handling OOS laboratory results will be the foundation for this webinar, which will offer a clear process for compliant laboratory Out of Specification investigations.

Jerry will cover the following areas at this webinar:

o  Why the regulators are concerned about the handling of OOS investigations

o  The FDA model for handling OOS investigations

o  Commonly accepted terminology such as repeat testing and retesting

o  How the laboratory can meet regulatory expectations for OOS investigations.

o  The interaction between the laboratory and other units in the organization.

http://www.fda.gov/downloads/drugs/guidances/ucm070287.pdf

http://sphinxsai.com/2013/JulySept13/phPDF/PT=11(943-948)JS13.pdf

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.