Who oversees the trial, has to undertake to the FDA

A vital document required when carrying out a clinical trial is FDA Form 1572 Statement of Investigator. It is a contract between the Principal Investigator (PI) and the FDA. FDA Form 1572, or just 1572, has all details of the subjects in the research, as well as the commitments the PI, who oversees the trial, has to undertake to the FDA. This commitment concerns meeting all the requirements from the FDA as they relate to the trial.

When the PI signs the FDA Form 1572, which relates to IND studies, or the “Statement of the Investigator, which is meant for IDE studies; she undertakes a commitment that she will comply with all the appropriate regulations and will be liable to facing legal action in the event of failing to do so. Hence, the FDA Form 1572 is a strongly legally binding document which sets out the terms of the commitment between the PI and the FDA.

The FDA has created the form 1572 with two main intentions:

It aids the FDA in gauging the PI’s suitability for overseeing the study, as it requires the latter to declare criteria related to this, such as experience and qualification. It also helps it understand the purpose of the study and the suitability of its methods to help it achieve its aims. Not only the FDA, but also the sponsor of the study can get this information from the form 1572.

Additionally, the FDA Form 1572, by taking an undertaking from the Principal Investigator that she will meet the requirements set out by the FDA during the trial; criminalizes the failure on the part of the PI to meet these conditions. It treats this as giving false statements, which empowers the agency to proceed legally against the PI under 18 USC 1001. When the sponsor selects the Principal Investigator to conduct a clinical trial as an investigational new drug (IND) that meets the criteria set out in 21 CFR 312.53 (c); this form has to be submitted.

Other documents accompanying the 1572

In addition, the following documents, which set out the general and specific responsibilities that the Investigators have when conducting a clinical trial; have to accompany the FDA Form 1572:

  • 21 CFR 312.50: contains the General Responsibilities of Investigators
  • 21 CFR 812.100: sets out the Responsibilities of Investigators for Biologics
  • 21 CFR 812.110: details the Responsibilities of Investigators for devices.

Get to understand the workings of FDA Form 1572

With the FDA Form 1572 being of crucial importance, compliance with it is not something that a sponsor or a PI can take lightly. Meeting the regulatory requirements set out in this document is in the interest of everyone concerned.

It is with the purpose of familiarizing the aspects relating to FDA Form 1572 that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing a webinar.

The speaker of this webinar, Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena, will offer insights into the nature of the due diligence that investigators and their staff have to take in meeting their regulatory and legal responsibilities.

Please register for this highly educative webinar by visiting Form FDA 1572 Seriously

FDA Form 1572 contains nine statements, seven out of which begin with “I agree”. Some of the essential elements named in the 1572 include:

  • 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.

Also, additional responsibilities are outlined in GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811. In addition to complying with the principles of Good Clinical Practices (GCP); the PI and sponsors are advised to also use their discretion.

At this session, the speaker will offer complete clarity on these aspects. The following areas will be covered 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?

For updates from this please https://goo.gl/forms/SNAcsW8rLKPrzxLD2

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Misinterpretation of closed Data when Treated with “Normal” Statistical Methods

Geology is among the many branches of science in which compositional data (CoDa) arise naturally. In branches such as geochemistry, compositional data seem to occur typically, when one normalizes raw data or when one obtains the output from a constrained estimation procedure, such as percentages, ppm, ppb, molar concentrations, etc.

Compositional or constrained data have proved difficult to handle statistically because of the awkward constraint that the components of each vector must sum to unity. The special property of compositional data (the fact that the determinations on each specimen sum to a constant) means that the variables involved in the study occur in constrained space defined by the simplex, a restricted part of real space.

It is important for geochemists and geologists in general to be aware of the fact that the usual multivariate statistical techniques are not applicable to compositional data. They need to have access to appropriate techniques as they emerge and become available.

Pearson was the first to point out dangers that may befall the analyst who attempts to interpret correlations between Ratios whose numerators and denominators contain common parts. More recently, Aitchison, Pawlowsky-Glahn, S. Thio, and other statisticians have developed the concept of Compositional Data Analysis, pointing out the dangers of misinterpretation of closed data when treated with “normal” statistical methods.

Learning about all elements of CoDa

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will throw light on all the important aspects of CoDa. At this session, Ricardo Valls, a professional geologist with thirty years in the mining industry, and who has extensive geological, geochemical, and mining experience, managerial skills, and a solid background in research techniques; will be the speaker.

To gain insights into CoDa, please enroll for this webinar by visiting  real case studies developedreal case studies developed

At this session, Ricardo will present several real case studies he has developed, to demonstrate the advantages of applying various aspects of the CoDa analysis in the search for and evaluation of ore bodies by comparing them with regular statistical modelling of geochemical data.

At this webinar, which will be of high value to personnel involved in mining, such as Geologists, Geochemists, Exploration Personnel, Graduate Students, and Post-Graduate Students; Ricardo will cover the following areas:

o  History of the Problem

o  The Current Situation

o  The Model

o  Normal Statistical Processing of the Data

o  Compositional Data Analysis

o  Factor and Principal Component Analysis

o  Dealing with zero and b.d.l. Values

Conclusions and Recommendations.

For more click the advantages of applying different aspects

Learn How to manage and improve Human reliability

Manufacturing is a behemoth of an activity that straddles several industries. Modern manufacturing has come a long way from the days of its infancy, which can be traced to the Industrial Revolution of some 250 years ago. Getting advanced and refined at many stages; production or industrialization or manufacturing is the lifeblood of most of the world’s economies. Automation in the processes may have been introduced in many industries; yet, manufacturing continues to depend heavily on human labor.

Although industrialization and manufacturing came about from the human intellect and endeavor; it is still prone to human error. It is a fact that wherever there is human involvement, there is scope for error. This is because we are humans after all. We can take the highest diligence in the work we do, but can make errors. On most occasions, these are unintended, but the result is negative. Errors in the manufacturing processes will continue so long as humans are involved in manufacturing to some or another degree.

Human errors can bring high costs

Manufacturing being an interlinked activity; human errors can cause many problems. One small error in the chain can affect the whole process, triggering a whole chain of errors. Although precise assessments cannot be made of the loss caused by human error; it is roughly estimated that the American and British pharma industries alone accrue losses of around $25 billion a year due to this factor.  Further, unexpected runtime error, which results in loss of more than a third of the productive time; is a direct consequence of human error. Human error can also lead to losses relating to quality and production. It is the cause of many performance issues.

It has to be understood that even with the knowledge of the consequences of human error, and with all the advancements and developments that have been made in high end, precise technologies and processes; the manufacturing sector is not likely to eliminate human errors. They can only be mitigated and minimized.

Getting to the root of the problem is important

Most manufacturers resort to a disjointed approach to human error. The positive approach to containing human error should be to locate its source. It is a fact that human error starts at the earliest stage, the design stage. Although this is known to many manufacturers and they are equally aware of the fact that training is a great tool to reduce human error; many in the manufacturing sector don’t take training seriously.

Along with training, other factors such as controlling the procedures and the workplace environment, where the various variables that affect human behavior converge, need to be taken into consideration. The manufacturer should directly address the systemic weaknesses to improve or fix them. An understanding of human behavior and the psychology of error is necessary to do this. Getting to the root of human error involves these among others:

 

o  Implementing human factors in manufacturing

o  Communicating in the right manner

o  Fostering continuous practice

o  Imparting the proper methods of training

o  Offering a thorough description of the right procedures with the right instructions

o  Bringing about a positive work environment

o  Putting the right processes in place.

A training session on understanding 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 a webinar on human error that Compliance4All, a highly acclaimed provider of professional trainings for all the areas of regulatory compliance, is organizing.

Please enroll for this webinar by visiting Human Error Reduction

Practical approaches to all areas of human error

Ginette will offer a complete understanding of the nature of human error, its roots, and its psychology. This webinar seeks to help regulatory and quality professionals get a thorough idea of the factors that cause human error. In order to facilitate proper understanding of this topic, the speaker will offer practical approaches and tools to address human performance issues in manufacturing. The understanding of the human psychology and behavior behind human errors that she will offer will give insights to where the weaknesses lie. This in turn will help to address the human performance issues and help correct and prevent recurrences of human error.

The following areas will be covered at this webinar:

  • Background on Human Error Phenomena and measurement
  • Importance of Human Error Prevention/reduction
  • Quantitative and qualitative information gathering
  • Why do we need tools for human error reduction programs?
  • Training as a tool and human error
  • Facts about human error and training
  • Human Error as the Root Cause: what to do and how to measure it
  • Tools
  • Prediction
  • Root Cause Analysis
  • Cognitive load assessment
  • Systems available
  • Human error rate
  • Floor checklist
  • Interview questions
  • Human error rates and other metrics
  • Trending and tracking
  • CAPA effectiveness
  • Metrics and Human Error
  • KPI’s
  • Human Error rate
  • 1st time pass rate
  • Overall equipment effectiveness (OEE)
  • Trending /Tracking

For updates click the below Link Human error rates and other metrics

When SSARS does and does not Apply to Preparation Engagements

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

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

 

Supersedes Section 19

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

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

Section 70: Preparation of Financial Statements

Section 80: Compilation Engagements

Section 90: Review of Financial Statements

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

Complete clarity on Section 21

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

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

Understanding of all aspects of Section 21

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

She will cover the following areas at this webinar:

o  Understand general requirements for SSARS engagements

o  Learn details of new financial statement preparation engagement requirements

o  Review compilation and review engagement requirements

o  Discuss the elimination of “management use only” compilations

o  Understand new formats for compilation and review reports

o  Compare and contrast preparation, compilation and review engagements.

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

For more updates one click

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

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

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

The issue of credit card surcharging in the US

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

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

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

Total clarity on the issue

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

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

Clarity on all aspects of credit card surcharging

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

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

At this webinar, Ray will cover the following areas:

o  What changed in the rules?

o  Why did it change?

o  What rules apply to surcharge?

o  Survey results

o  Who may benefit?

o  Will this change anything?

o  Summary.

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

For more Interesting topics

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

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

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

o  Increased capital regulation

o  Improved stress testing and capital planning

o  Regulation of the liquidity requirements

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

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

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

Based on evolving priorities and situations

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

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

Learning about how to understand exam initiatives

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

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

Understanding how the priorities suit participants’ organizations

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

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

Lisa will cover the following areas at this webinar:

o  Learn how to gain access to the financial regulators priorities

o  Understand how to apply those priorities to your firm

o  Incorporate the priorities into your annual review

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

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

o  Other sources for annual priorities.

For more updates and Articles Click here

What You Need To Know For Validated Systems?

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

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

Computer Systems Validation has a major role

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

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

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

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

Valuable learning on lean validation 

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

Please enroll for this webinar by visiting concept of Cybersecurity Qualification

Full aspects of cybersecurity

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

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

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

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

o  Understanding Cybersecurity Regulatory Guidance and Standards

o  Cybersecurity Qualification: The NEXT Frontier

o  Automated Testing in the Cloud

o  Top 20 Critical Security Controls for Validated Systems

o  Cloud Security Technology Maturity

o  Cloud Quality Assurance & Governance

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

o  Understanding the NIST Cybersecurity Framework for Validated Systems.

Here to continue further How to mitigate and protect validated systems