The FDA’s Adverse Event Reporting Requirements

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The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action.

The adverse event reporting system may be understood as being a database that aids and supplements the FDA’s postmarketing surveillance program for all its approved products that fall in the category of therapeutic biologics and drugs. So, this database has a record of the adverse event reporting done by all individual and sponsors of their clinical trials. It is a catalog of all the error reports that get generated at various times and stages of the clinical research program.

Voluntary in nature

The FDA's Adverse Event Reporting Requirements4

The outstanding aspect of the FDA’s adverse event reporting requirements is that these reporting requirements are not mandatory. Yet, those involved in clinical research, such as sponsors, healthcare and pharmaceutical organizations, institutions and individuals strictly adhere to adverse event reporting requirements in order to steer clear of legal entanglements that could come their way in the future, and to help other players keep track of all adverse events.

Some of the core adverse event reporting requirements

The FDA's Adverse Event Reporting Requirements1

Applicants should electronically submit all Individual Case Safety Reports (ICSRs) for human drug and nonvaccine biologic products in xml format. Among the adverse event reporting requirements, this has been in place from 2000.

The FDA has been amending rules relating to adverse event reporting requirements from time to time. According to the amendment passed in June 2015; the following adverse event reporting requirements apply:

All applicants should submit all ICSRs, ICSR attachments, and periodic safety reports electronically. They can do this using either of these options:

The E2B method specifies that the files should be in xml format, and the attachments in pdf.

The FDA's Adverse Event Reporting Requirements3

The Safety Reporting Portal (SRP) is meant for those applicants that do not have the database-to-database capability. To fulfill this among the FDA’s adverse event reporting requirements, the applicant needs to have an account with which to access the portal site. FDA’s adverse event reporting requirements state modes and criteria that applicants have to meet to request an SRP account, to activate the account, to add attachments, and for submitting Periodic Safety Reports (PSR).

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Internal Audit Checklist for HIPAA

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The internal audit checklist for HIPAA is one of the primary elements of HIPAA implementation. The passage of the Health Insurance Portability and Accountability Act (HIPAA) by the U.S. Congress in 1996 was aimed at regulating the way and process by which healthcare institutions across the country reveal the medical information of their patients.

The Department of Health and Human Services (HHS) is tasked with monitoring the compliance aspect of the law, i.e., it monitors how medical organizations comply with the provisions of HIPAA. In order to ensure that medical organization stay compliant with the provisions of HIPAA; auditors measure these compliance aspects with a checklist when testing companies’ medical data recording processes.

The internal audit checklist for HIPAA, like any other checklist, is a list of do’s and don’ts that a healthcare organization has to look to see if it is complying with its processes relating to medical data sharing and recording. These are the core areas against which auditors prepare and monitor the internal audit checklist for HIPAA:

Analysis and assessment of risk

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One of the foremost aspects of the internal audit checklist for HIPAA is the organization’s analysis and assessment of the risk involved in disclosing medical information. Medical organizations of the designated types have to carry these out at regular, periodic intervals in ensuring that they don’t give opportunities for causing data breaches. Since healthcare organizations are involved in collecting, keeping and transferring of medical information; it is necessary for them to keep analyzing and assessing the risk involved in data breaches.

Gap analysis

In this category of internal audit checklist for HIPAA; auditors compare regulatory guidelines to security systems in the corporate sector. The idea is to help the medical organization outline its security requirements vis-a-vis its security infrastructure

Remediation

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In this internal audit checklist for HIPAA; the healthcare organization relies on a number of technologies and steps to prevent any breach of data, and to also offset the damage done when a breach happens. The primary tools used in this internal audit checklist for HIPAA include software used for tracking defects, for process reengineering, CRM and a few ERP applications.

Planning for contingencies

An internal audit checklist for HIPAA also includes a set of plans that the healthcare organization has to have to be able to plan for contingencies. A healthcare organization can expect emergencies or disasters from any source, and these can be of any kind. An internal audit checklist for HIPAA should include plans for anticipating and dealing with these.

Personnel policies

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The policy a healthcare organization puts in place for its personnel is an important point in the internal audit checklist for HIPAA. It has to decide what kinds of trainings its staff members receive for implementing HIPAA compliance.

 

 

 

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Understanding the importance and benefits of auditing Quality Management Systems

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Auditing Quality Management Systems is a core requirement for ensuring that Quality Management Systems – defined as “…a set of policies, processes and procedures required for planning and execution” in the core business area of an organization, meaning those that impact the ability of the organization to meet customer requirements – are updated and kept in compliance with regulatory requirements. The ISO 9001 set of standards is a step towards helping organizations achieve this end.

The ISO 9001 series, aimed at facilitating and ensuring that organizations of various kinds audit their Quality Management Systems in tune with regulatory requirements set out in this standard; was first implemented in the 1980’s. Today, across the globe, over a million organizations have been certified for complying with its requirements. The ISO 9001 is a tool for auditing Quality Management Systems across all kinds of organizations: big, small or medium to one stop providers to multinational organizations that operate in various geographies.

Why is auditing of Quality Management important?

Understanding the importance and benefits of auditing Quality Management Systems2

ISO standards have been arrived at after years of practice, observation and trial and error endeavors. These standards have evolved over continuous implementation of many best practices that are suited to particular organizations based on the size of their operations and the nature of their business.

An organization that has been in the practice of auditing Quality Management Systems is said to be implementing a better way of dealing with risk management. It is also considered an organization that enjoys enhanced stakeholder and customer confidence, as well as an improved, efficient and effective management and operational systems.

More than anything else, auditing Quality Management Systems are the surest means to ensuring that products and services from an organization meet certain prescribed processes and standards. An auditing Quality Management System officially certifies that the organization task a risk-based, process oriented, streamlined approach to ensure the safety, reliability and consistency of its products and services. A company that puts auditing Quality Management Systems in place is said to be more conscious of meeting customer expectations and makes continuous efforts and improvements into its products and services and complies with the law.

Certification is proof that the organization is auditing its Quality Management Systems

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Certification is like the proof of the pudding in Quality Management Systems audits. A company may claim to be implementing quality standards, but how does the world come to know about it? It is only through auditing Quality Management Systems certification that this happens. For a company to earn auditing Quality Management Systems certification; it has to be audited by the ISO. Upon careful scrutiny of its practices, the ISO awards the organization the 9001 Quality Management Certification.

What are the benefits of auditing Quality Management Systems certification?Certification from the world’s leading Quality Management Systems auditing certifying body gives such an audited and certified company a host of credentials and benefits. These are some of them:

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It is important for non-statisticians to become familiar with biostatistics

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Statistics is extremely useful as a decision-making tool in the clinical research arena. In areas such as working in a field where a p-value can determine the next steps on development of a drug or procedure, it is very handy, because of which it is imperative for decision makers to understand the theory and application of statistics.

Many statistical software applications have now been developed and made available to professionals. It needs to be borne in mind that these software applications were developed for statisticians, because of which its use can baffle non-statisticians. Their confusions could be as basic as pressing the right key, let alone performing the best test.

A full learning session on biostatistics for the non-statistician

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A seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will throw light on the importance of biostatistics for the non-statistician.

Elaine Eisenbeisz, a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California, who has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations to start-up companies and individual researchers; will be the Director of this seminar.

Want to understand the importance of biostatistics for the non-statistician? Then, please enrol for this seminar by visiting It is important for non-statisticians to become familiar with biostatistics. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Statistical concepts in clinical research

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Designed essentially for non-statisticians; this seminar provides a non-mathematical introduction to biostatistics. It will be of high value to professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

Elaine will equip participants of this seminar with the information and skills necessary to understand statistical concepts and findings as they relate to clinical research. With this information, they will be able to confidently communicate with people with whom they need to.

Elaine will place emphasis on the actual statistical concepts, application, and interpretation. She will not go into the areas of mathematical formulas or actual data analysis. A basic understanding of statistics is desired from the participants, but is not necessary.

This course on biostatistics for the non-statistician will help professionals involved in this area, such as Physicians, Clinical Research Associates, and Clinical Project Managers/Leaders, Sponsors, Regulatory Professionals who use statistical concepts/terminology in reporting, and Medical Writers who need to interpret statistical reports.

Elaine’s agenda for this two-day seminar will consist of the following:

Why Statistics?

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  • Do we really need statistical tests?
  • Sample vs. Population
  • I’m a statistician not a magician! What statistics can and can’t do
  • Descriptive statistics and measures of variability

The many ways of interpretation

  • Confidence intervals
  • p-values
  • effect sizes
  • Clinical vs. meaningful significance

Common Statistical Tests

  • Comparative tests
  • Regression analysis
  • Non-parametric techniques

Bayesian Logic

  • A different way of thinking
  • Bayesian methods and statistical significance
  • Bayesian applications to diagnostics testing
  • Bayesian applications to genetics

Interpreting Statistics – Team Exercise

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  • Team Exercise: Review a scientific paper and learn how to
    • Interpret statistical jargon
    • Look for reproducibility, transparency, bias, and limitations
    • Convey information coherently to non-statisticians

Study power and sample size

  • Review of p-value, significance level, effect size
  • Formulas, software, and other resources for computing a sample size

Developing a Statistical Analysis Plan

Specialized topics/Closing Comments/Q&A

  • Comparing Survival Curves
  • Pharmacokinetics/Pharmacodynamics (PK/PD)
  • Taking a holistic view to study design and interpretation
  • Question and Answer session.

 

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The ISO 13485: 2016

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The ISO 13485, which is the ISO’s global medical device standard; was upgraded significantly in 2016. This upgrade was carried out primarily to help the standard keep up with the changes that have taken place in the industry in about the decade and a half since the previous standard was brought into effect in 2003. Changes have taken place in a number of key areas of the medical device field, but the most important changes relate to the changes in technology and in relation to the increased importance of risk management at almost all levels in the medical device industry.

The earlier version was based on the ISO 9001:2000 standard, while the new upgrade is based on a later standard, the ISO 9001: 2008. Changes have been carried out into almost all the sections of the new standard, with the most important areas that have been changed including flexibility, the requirements from medical device companies to adhere to regulatory requirements, the inclusion of the risk based approach into the organization’s QMS, medical device filing and documentation, verification and validation, design and development, training, supplier monitoring and so on.

QMS is an important area of change

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The QMS is the most prominent area in which the new document differs from that of the earlier version. Although the new version is considerably more closely aligned to the FDA’s Quality System Regulations (QSR); there still exist major differences. Not getting a proper grasp of these differences has the potential for creating problems in implementation.

Medical device companies also need to consider the Medical Device Single Audit Program (MDSAP), the mechanism through which the regulatory systems in a few jurisdictions will continue to rely on ISO 13485:2016. In relation to this mechanism, the fundamental difference between the US and the EU is this: the US will participate in MDSAP, but doesn’t expect to change its regulations, while the EU is not going to participate. It has published its own version, EN ISO 13485:2016, and will continue with the existing Notified Body system. however, the EU will promulgate in its own set of new regulations that will replace the directives. These will lead to new regulations, which will be new versions of EN ISO 13485:2016 and EN ISO 14971:2012.

It is crucial for medical device companies to keep track of the changes introduced in ISO 13485:2016, as this is the new standard that they have to comply with. While it is not legally binding to do this; they gain in a number of ways in being compliant with these changes.

Proper and full learning of the ISO 13485:2016

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Being compliant with the new version requires a clear understanding of the new regulation, the ways in which it has to be implemented, the areas of work that need to be changed, and so on. A seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will explain all these.

At this seminar, the Director is Dan O’Leary, who is the President of Ombu Enterprises, LLC. Dan, who brings more than 30 years’ experience in Quality, Operations and Program Management in regulated industries including aviation, defense, medical devices, and clinical labs, will offer a complete understanding of how the new regulation needs to be implemented.

Please log on to The ISO 13485: 2016 to enroll for this seminar and get the right perspective of how to implement ISO 13485:2016. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Implementation needs to be done quickly

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The final version of the new ISO 13485:2016 standard is now available for companies to start implementing. The areas into which changes have to be carried out are quite expansive and huge in number. For many companies, the timeframe for implementation is quite short, depending on the expiry date of their current certificate. Dan will help participants overcome this handicap, and will offer practical implementation advice and suggestions to participants.

He will also use exercises and examples to help participants understand the ways of implementing according to the new guidelines and also analyze the implications of the newly revised regulation, in particular, regulatory systems including MDASP and its nonconformity grading system. This seminar will have the following agenda:

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Testing GxP system that is FDA-compliant

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Process validation is the method of using data from stages ranging from the process design stage to production, to ensure that the process that is being used can deliver consistently high-quality products. Companies that come under the life sciences must comply with GxP regulations to ensure that their processes meet the regulatory guidelines to be GxP compliant. Computer Systems Validation is the method of ensuring that all computer systems used that go into the production of products in the life sciences industry comply with set regulations and meet the specifications relating to quality.

For the FDA, CSV is more than just hardware and software. It also includes any instruments that are linked to the computer system or are part of it, as well as staff that operate the computer system under set SOPs. The FDA considers GxP as being much broader, as it includes static and dynamic testing.

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Testing and verifying of computerized systems is a crucial aspect of GxP systems. It is a means for showing that a computer system meets the intended requirements. Carrying out testing properly and appropriately is a major regulatory expectation, whose scope and nature have been defined by many regulations from the FDA, the EU’s GMP Annex 11 and other documents.

So, any regulated company has to demonstrate compliance with GxP regulations and show how fit these products are for their intended use. The criterion for the effectiveness of testing is its ability to show compliance with regulatory requirements. This is a means to ensuring the following:

  • Patient safety
  • Product quality
  • Data integrity as a result of controlling identified risks.

The guarantee that systems perform as intended for their use shortens the overall lifecycle of implementing and operating the system. It also prevents delays to the use of the system that could have happened because of the time taken to make corrections to the system.

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At the other end, not carrying out testing adequately or appropriately could result in issues that could surface later on in the lifecycle. Detecting and fixing them at that point is very expensive, cumbersome and very time consuming. Not only do such systems fail to meet intended requirements; they also incur exorbitant costs into corrections, maintenance and support.

Not only these; not adequately and appropriately carrying out test functions adversely impacts in any or all of these:

  • Patient safety
  • Product quality
  • Data integrity
  • Regulatory compliance requirements
  • Ability to meet intended use of the system.
  • Stringent actions from the regulatory agencies, which could include citations and other penalties
  • The business bottom line and the company’s credibility.

A thorough guidance session

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As can be seen from all these; testing of the GxP systems is an area in which no company can afford to be lax. The means of doing this in the right manner that meets the regulatory expectations and help avoid all of the undesirable effects listed above will be taught at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

Angela Bazigos, a seasoned executive with 40 years of experience in the life sciences & healthcare industries, who is CEO, Touchstone Technologies Silicon Valley, will be the Director at this seminar. Please log on to Testing GxP system that is FDA-compliant to enroll for this seminar and gain from the experience that Angela brings into life sciences. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All areas and aspects of GxP testing

The various GxP testing methods and their varieties should be based on risk, complexity and novelty of the software. The aim is to confirm that system specifications have been met. The company may have to carry out multiple stages of review and testing depending on the type of system, the development method applied and the use of computerized system. The testing being of such a complex nature; companies should have the ability to justify the method chosen and the sufficiency of their testing approach.

The use of a scientific Quality Management System such as ICH Q9 to determine the appropriate level of verification and documentation goes a long way in making the testing process effective.  Demonstrating that all required risk controls are in place is one of the purposes of designing tests. Whenever changes are proposed to the system, they should be followed by an impact analysis to determine the extent of any reverification, including any regression testing required. These changes to the system should be made only in accordance with a predefined change control procedure, which should include provision for proposing, approving and/or backing out of the change.

Angela will explain all these in detail at this session. In the process of this explanation, she will cover the following areas:

  • How does testing fit into GaMP5 lifecycle?
  • Risk based methodology for testing
  • How do I leverage supplier testing?
  • What should I test?
  • How much testing is enough?
  • How should I conduct the tests?
  • How should I document my testing?
  • How do I maintain the testing integrity of my system?
  • Testing related 483s and Warning Letters
  • Case Studies.

 

keep continue to FDA compliant

 

 

 

 

Understanding the infinite area of medical device compliance

Understanding the infinite area of medical device compliance 1.pngWith a seemingly unlimited number of products coming under the broad umbrella of medical devices; it is but natural that regulations for these products are equally expansive. This makes medical devices compliance an extremely enormous and broad topic.

With the FDA being the sole regulator for this very vast area; it comes up with regulations, and expects medical device manufacturers to comply with them. This is part of the FDA’s primary function of assuring quality from medical devices. Compliance with these medical device regulations ensures that companies’ products meet the quality and safety and integrity of medical devices.

Areas of medical device compliance regulations

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The FDA’s regulation of medical devices and a few nonmedical devices cover the areas of manufacturing, repackaging, and relabeling, and/or importing. The regulations for medical devices are set out in 21 CFR Part 807, whose various sections detail all the requirements for compliance for Class I, II and III medical devices. The following are the activities connected with compliance for medical devices:

  • Registration of the establishment
  • Listing of the medical device
  • 510 (k)
  • Premarket approval
  • Investigational Device Exemption (IDE)
  • Quality Systems
  • GMP
  • Device labeling
  • Device reporting.

A thorough understanding of the FDA medical device compliance areas

Understanding the infinite area of medical device complianceThe ambit of the FDA’s regulations being very wide; it is important for medical device companies to have clarity on the many FDA medical device compliance regulations. This understanding will be offered at a seminar being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the areas of regulatory compliance.

The Director of this two-day seminar is Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc.

Please register for this webinar by visiting Understanding the infinite area of medical device compliance . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Helping to strategize compliance for medical devices

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Medical device companies need to put in place a sound strategy for medical device compliance. A certain level of strategic thinking alone ensures this. Susanne will show participants how to inculcate this thinking and instill it into the organization. She will show how to be cost-effective while improving the quality and compliance of medical devices. The ways of building a sound Quality System, which is at the root of medical device compliance; will be imparted.

An effective and efficient Quality System can only be implemented based on a thorough understanding of what the regulatory requirements mean, and adapting them into the Quality System. The ways of doing this will be the core of this seminar. Susanne will demonstrate the ways by which to plan, structure and implement a Quality System that addresses the specific business needs of the participants.

Addressing issues within a Quality System

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The methods for identifying, prioritizing and analyzing risks will be explained during the discussion on how to create a quality strategy and plans. Susanne will help participants explore the capabilities needed for every medical device to meet quality standards and implement compliant Quality Systems.

Also taken up for discussion are areas related to continuous improvement, Six Sigma, and Corrective and Preventive Action (CAPA), which are important components for addressing issues within a medical device company’s Quality System. Susanne will help with this very important aspect.

Over these two days, Susanne will also take up other crucial aspects of medical device compliance. These include:

  • Effectively communicating and escalating risk
  • Monitoring performance and progress
  • Kick starting the Quality System to avoid common problems such as MDRs, recalls, 483s, and Warning Letters.

Susanne will cover the following areas at this seminar on medical device compliance:

  • Quality System Expectations
  • Quality System Structure
  • Strategy and Planning
  • Risk management in your quality system
  • Case for Quality
  • Inspection preparedness and management
  • Monitoring and metrics
  • Creating a quality strategy and plans.

continue to improve the medical device compliance