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Do human factors matter in medical devices?

The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents

Do human factors matter in medical devices1

Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for optimizing the production of devices, systems, and many others concerned with them through the use of emotional, intellectual, physical and sensory forms of human knowledge. Both the ways in which these elements are used to enhance production, as well as the limitations inherent into them are factored in. In essence; human factors deal with how humans and devices or machines interact with each other.

Since human factors places the human mind at the center; design and aesthetics play a very prominent role in this discipline. Being an important element of user interface; human factors and user interface have risen in prominence after the explosion of the field of IT. It however, can be put into use in several other areas. The user being the fulcrum of any area of production; human factors has the potential to be a major factor in creating and shaping user interface for a range of products.

Use in medical devices

Do human factors matter in medical devices

How about the area of medical devices? We have seen that user interface and aesthetics are core ingredients of human factors. Are these the major determinants for the field of medical devices? Yes and no. Yes, because the user is of critical importance in medical devices. A wrong instruction or wrong usage can severely compromise the use of medical devices and can go the extent of even causing harm to the user.

No, because when it comes to another equally important element of human factors, namely aesthetics, the interplay between medical devices and human factors may not appear so pronounced. Yet, while role of aesthetics may not be all that critical to medical devices; there is a related aspect, and that is design.

The role of design is very prominent when it comes to the user interface of medical devices since medical devices have to be designed to absolutely precise specifications. Even small deviations or variations can result in harm to humans. Both the patient and the organization manufacturing the devices need to face consequences as a result of these.

As far as medical devices are concerned, the FDA is tasked with regulating them for ensuring their safety and effectiveness. The incorporation of the principles of human factors into medical devices ensures that the product meets specification, design and quality standards and thus becomes faster and less expensive to market. It is because of these factors that human factors are becoming part of the design and development, as well as of the supplementary aspects of medical devices, such as Instructions for Use, labeling and even training.

FDA’s regulations on human factors in medical devices

FDA_s regulations on human factors in medical devices

Under 21 CFR 820.30; the FDA emphasizes that human factors need to be taken into consideration for the following:

  • Design input: To ensure that the needs of the patient and any others who may use the product are taken into consideration

 

  • Design verification: To make sure that the criteria for performance set for the medical are being consistently met, and

 

  • Design validation: To safeguard that the device conform to predefined user needs as well as intended uses, and to also sure that testing is carried out to ensure this function. Software validation and risk analysis are part of this testing.

The FDA has also been placing emphasis on human factors in medical devices in many guidance documents and a number of upcoming Draft Guidance documents.

Full learning on human factors in medical devices

A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance will offer complete learning on human factors in medical devices.

Virginia A. Lang, Principal and Founder HirLan, Inc. and HirLan International SA, will be the Director of this seminar. To gain knowledge of how human factors related to medical devices, please register for this seminar by visiting Do human factors matter in medical devices? This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A complete explanation of regulations and uses of human factors in medical devices

The core aim of this seminar is to familiarize participants with the way in which human factors can be applied into medical devices. Towards covering this, she will explain all the current and upcoming human factors requirements, using which, participants will learn how to keep costs under control and reduce the time for the manufacture and marketing of their products.

Virginia will cover the following areas at this seminar:

  • Overview of Human Factors and the FDA perspective
  • Human Factors Methods and Device Product Life Cycle
  • Human Factors and Risk Analysis & Management
  • Human Factors: What Devices Require Human Factors Evaluation and Validation?
  • Human Factors and Combination Products
  • Human Factors and Combination Products Submitted in an ANDA.

 

 

 

Featured

Knowledge of employment laws is absolutely crucial for organizations

support for protection of the domestic workforce will mean to employment laws

As the new presidential administration settles in in the US, employment law could be an area in which to expect tremendous changes. While what the new president’s open and vocal support for protection of the domestic workforce will mean to employment laws may take some to fully unfold and unravel; a look at the evolution of the important employment laws and the changes taking place into them of late should serve as some kind of indication of what is to come.

One thing that is certain is that 2017 is going to be an uncertain year for employment law. Changes that could make a big difference to many organizations can be expected to be rolled out by the new administration. A fact of additional significance to employers is that there has been a steady increase in the number of employment lawsuits of late.

In 2016, enforcement actions by the Equal Employment Opportunity Commission (EEOC) gave the agency a staggering amount of between $350 and $400 million in monetary damages. This has been the highest recovery ever from the time it was created in 1965. Not surprisingly, the number of claims filed by employees with this Commission has reached record levels in the last three years.

Lack of knowledge of the law is at the root of lawsuits

Most of these lawsuits are a result of the lack of understanding that employers have of workplace issues. Companies in which the managements are ignorant about these issues or choose to overlook them end up facing a host of issues such as:

o  Discrimination suits

o  Employee turnover

o  Unplanned expenses

o  Settlements

o  Litigation

o  Lawyer fees

o  Low morale on the part of employees

o  A bad beating to their image.

The means to avoiding such scenarios is for organizations to grasp the enormity of these actions. If they have to avoid litigation and other reputation-damaging actions; they need to be aware of the employment law regulations and be compliant with these. They also need to be clear in their understanding of what to expect from the new administration.

A session to help get thorough understanding of employment laws

It is to impart understanding of these topics that a GlobalCompliancePanel, a leading global name in the field of regulatory compliance trainings, will be organizing a two-day seminar. Vanessa G. Nelson, who is founder and President of award-winning Expert Human Resources, which she founded to help companies maintain employment law compliance, avoid workplace litigation, maximize human capital, create great teams, and reduce costs, will be the Director of this course.

To get complete understanding of all the crucial aspects of human resource law, the ways by which to comply with employment laws and regulations and the potential impact on employment law from the actions of the new administration; please register for this seminar by visiting Knowledge of employment laws is absolutely crucial for organizations .

A clear roadmap to advanced human resources and employment law

The essence of this seminar is the roadmap to advanced human resources and employment law that Vanessa will lay out for the participants. Given the factors described above; this understanding is critical, no matter what the size of the organization. The right grasp of employment laws and HR practices is essential if organizations have to become successful at their business. The Director of this seminar will simplify the complex nature and the huge number and variety of employment laws and the issues relating to them.

Participants will able to learn the ways of dealing with often muddling human resource situations and how to apply relevant employment laws correctly to avoid problems. A look at the cost of litigation will perhaps give some idea about the need for employers to remain compliant with the employment laws: Without lawyer fees, a lawsuit costs $165,000 on average. The cost of a case that goes to trial is exorbitant: It is in excess of a million dollars, and comes with the strong prospect of imprisonment for noncompliance with employment.

Controlling Human Error in the Manufacturing Floor

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All the technological advancements in the automation processes of many industries notwithstanding, human labor continues to be a core part of manufacturing. This means that manufacturing is highly prone to human error. This is natural, because human error is inseparable from the human presence. Wherever there is human involvement, the potential for human error accompanies it, because, as the old saying goes, to err is human. With all the meticulousness that humans are capable of, the scope for human error can never be ruled out.

Human error has serious costs for the economy, because manufacturing is a vital industry in most countries of the world. Irrespective of whether the human error is intended or not, the loss that accrues from it is unavoidable. An error in one stage of manufacturing can spill over to other areas, curtailing the entire chain. It is no exaggeration that human errors cost the global economy billions of dollars in losses and kill incalculable productivity time.

GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on March 19, at which all the aspects relating to human error in manufacturing, and the ways of minimizing it, will be explained. GlobalCompliancePanel brings 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, as the expert at this webinar.

To enroll for this six-hour session, please visit Globalcompliancepanel .

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Ginette will drive home the point that although it is impossible to totally eliminate human error in manufacturing, it is possible to minimize it to the lowest level that one can bring it down to. Human error in manufacturing can start at the design stage and can go to all the areas such as procedures, training, and workplace environment, where variables are involved.

She will explain the ways by which an understanding of human psychology can help locate exactly where the error lies and correct the weaknesses in the system to the point where they can be fixed.

At this session, she will offer simple and practical tools which participants can use immediately and start reducing most human errors. This webinar will make a discussion of human error categories, near root causes and root causes for these events, as well as the current trends in human error issues in the manufacturing industry.

Participants will:

  • Understand human error: factors and causes
  • Understand the importance: regulatory and business
  • Define the process to manage Human Error deviations
  • Identify Root Causes associated to human error deviations
  • Learn how to measure human error rates at your site
  • Identify what to do to support human reliability.

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About the expert: Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.

 

Tougher Import Rules for FDA Imports in 2020

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Those who import FDA regulated products to the US need to be very meticulous in planning their activity. If they get any of these aspects wrong-registration, product compliance, record and data submission-their product can be detained.

Likewise, the requirements set out by the U.S. Customs and Border Protection (CBP) must be completely precise, failing which an importer’s item could get aborted before it enters US shores. While it is common for importers to make certain kinds of errors, most others accrue from a lack of understanding of how FDA and Customs and Border Protection (CBP) operate their joint program.

Importers should realize that any decision they take regarding the logistical aspects of importing products comes with its own set of consequences. They could end up coughing huge amounts of money, apart from the time they will have to spend in securing the release of their detained products.

This becomes all the more frequent if they do not know how to work with the FDA. Knowledge is a core factor there. For instance, being aware of the fact that they are not allowed to appeal if their entry is refused, or of the fact that they could face the prospect of attracting additional steep fines by CBP and get blocked from the U.S. market can go a long way in alleviating their problems.

It is knowledge of this kind that a webinar being organized on March 24 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is going to impart. This webinar, titled “6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2020”, will have Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, as the expert.

Please enroll for this learning by visiting globalcompliancepanel .

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Most problems concerning imports to the US market arise because importing firms are not aware of the ways of preparing, conducting and reporting information in a manner that meets the FDA’s requirements. The truth is that the FDA is more than willing to help importers who meet their requirements, but is equally harsh and unforgiving on those that don’t.

So, the basis to operating an import business and profit from the US market is to comply with the FDA regulations. Importers need to grasp the FDA’s and CBP’s import program, which is what this webinar will familiarize its participants with.

Casper will cover the following areas at this session:

  • FDA’s legal authority and burden of proof
  • FDA registration, product information and the software PREDICT screening program
  • CBP entry information and the Automated Commercial Environment (ACE) program
  • Tariffs, fees, bonded warehouses, and free trade zones (FTZ)
  • Special labeling requirements, e.g., bulk active pharmaceuticals, research use, investigational use, and return for repair
  • FDA “holds,” “detentions” and what to do immediately
  • Negotiating with FDA

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About the speaker:

Casper Uldriks, who owns the firm, Encore Insight LLC, specialized in the FDA’s medical device program as a field investigator, and served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements.

Over 32 years of having worked with the FDA, he understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.

 

 

 

Project Management for Non-Project Managers

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Project management is one of the skills even those whose domain of expertise it is not, are expected to know in detail. Project management is a very useful supplementary skill to have for non-project managers simply because every work in most organizations gets done as projects. When project managers or others who work on project management are unable to deliver-whatever be the reason for it-others are expected to fit into their shoes and deliver. This substitution can make the difference between the completion and noncompletion of a project.

A six-hour webinar from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will show how non-project managers can acquire knowledge of project management. This webinar, which is being organized on March 20, brings Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm, as the expert.

Kindly visit globalcompliancepanel  to enroll for this valuable learning and gain insights into how to ensure that projects do not get stalled for want of availability of the right personnel.

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Charles will give an understanding of the critical tasks within each project phase that non-project managers must perform rightly if the project is to be completed on time while meeting the requirements. This learning will offer a foundation and direction for future study of the subject.

Over the course of these six hours, Charles will offer the basic tools that smoothen the implementation of a project. These tools are vital to ensuring this. He will divide this webinar into two three-hour slots, during which he will offer learning of the ways by which to manage the project from beginning till end, moving logically across these endpoints during these two sessions.

This webinar is of core importance to any member of a cross functional project team that has the potential opportunity to lead that project, engineers, marketing associates, product managers, program managers, contract managers, project managers, Research & Development Associates, managers, and directors, design engineers, and manufacturing managers.

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About the expert: Paul’s company, C. H. Paul Consulting, Inc., is a regulatory, manufacturing, training, and technical documentation consulting firm. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

Paul has been a regulatory and management consultant and an Instructional Technologist for 30 years, and has published numerous white papers on various regulatory and training subjects.

Apart from holding senior positions in consulting and in corporate training development, he has also worked for several years in government contracting, where he has managed the development of significant Army-wide training development contracts. His work has impacted virtually all of the active Army and changed the training paradigm throughout the military.

 

 

Phase I GMPS

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Conducting early clinical trials is a means for establishing the initial safety of a drug.  Since these clinical trials are only a sample of the larger, actual trial, these studies generally consist of a small number of healthy subjects, on whom lower doses of the drug product are administered. This means that early clinical trials need only small amounts of investigational material.

The FDA, to help such companies from incurring higher costs, as also to reduce regulatory burden during these early stages, has established guidelines to allow early stage investigational products to be manufactured under what may be considered simulated conditions, i.e., those that require less stringent GMPs.

Understanding the way this system, called Phase I GMPS, is very important, as it sets the path for the fuller development of the drug. A four-hour workshop from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, which is being organized on March 26, will give a thorough understanding of Phase I GMPS.

Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar. Please visit globalcompliancepanel  to register for this valuable session and gain full understanding of Phase I GMPS.

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The aim of this four-hour webinar is to offer a detailed review of everything relating to early stage manufacturing and GMPS, such as the current regulations and guidance documents. Peggy will also review and explain regulatory strategies and logistical considerations for early development stage products. Core considerations of this aspect of early stage manufacturing and Phase I GMPS include vendor selection and management, stability, labeling, and documentation requirements.

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Directors, Managers, as well as supervisors in Regulatory Affairs, manufacturing, Quality Assurance and clinical operations, the primary segment that is expected to benefit from this webinar, will get a complete grasp of the differences between GMP requirements for early and later stage clinical development. The expert at this webinar will help them to explore and discuss ways of developing and implementing strategies for early GMPs for Phase I clinical studies.

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About the Expert:

Peggy J. Berry is the President & CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development. She is the editor of the 2010 book, “Choosing the Right Regulatory Career” and author of the 2011 book, “Communication & Negotiation”. She consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society.

 

Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

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Good Laboratory Practice (GLP) differs from Good Manufacturing Practice (GMP) in a fundamental way. GLP deals with preclinical development, while GMP has to do with manufacturing. That is, while GLP concerns itself with study, GMP is all about the method, i.e., the process.

GLP are a set of regulations for conducting nonclinical laboratory studies, and are not a set of guidelines. GLP is covered under 21 CFR Part 58, and regulate nonclinical laboratory studies that support or intend supporting applications for research or marketing permits for certain classes of products. These include:

  • Food and color additives
  • Human and animal drugs
  • Medical devices for human use
  • Biological products and electronic products that are regulated by the FDA.

Joy McElroy, Principal Consultant at Maynard Consulting Company, will, at a marathon four-hour session being organized on March 25 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, explain all the aspects of GLP while giving clarity on how it differs from GMP.

Please visit globalcompliancepanel to register for this important learning, at which the following areas will be covered:

  • What are Good Laboratory Practices
  • Why were they created
  • What is the objective of GLPs and how are they associated with GMPs and SOPs
  • Statistical Procedures for data Evaluation
  • Instrumentation Validation
  • Analytical and laboratory Certification
  • Documentation and Maintenance of Records
  • Consequences of Noncompliance
  • Disqualification and Reinstatement

This webinar is being organized for the benefit of personnel that deal with GLP and GMP in the course of their work, and include Quality Assurance Personnel, Quality Control Personnel, Research and Development Personnel, Regulatory Affairs Personnel, Project Managers, Manufacturing Managers, Validation Engineers, Internal Auditing Personnel, Microbiology Personnel, and Auditors.

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About the expert:

With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

The Interplay of the Americans With Disabilities Act, the Family and Medical Leave Act, and Workers’ Compensation

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The Americans with Disabilities Act (ADA), the Family and Medical Leave Act (FMLA), and Workers Compensation laws-the three core US laws concerning employment-are intricately related to each other. Their relationship with each other is such that it has earned the epithet, the “Bermuda Triangle of employment law”.

Considering that employers who come under these laws can be hauled up legally if they fail to comply with these laws; it is absolutely essential for them to understand the nitty-gritty of each of these laws and the way each relates to the other. The penalties that attach to noncompliance are significant. So, employers are morally and legally bound to implement the ADA, FMLA and Workers Compensation laws at their organizations to ensure that the employees receive the benefits and protections these laws provide.

To do so, everyone in the organization concerned with the application of these laws, such as senior leadership, human resources professionals, compliance professionals, payroll professionals, and operations professionals, needs to be aware of the meaning, purpose and detail of these laws.

It is to familiarize them with not just the letter, but also the spirit of these laws that GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is organizing a six-hour learning session on the topic, “The Interplay of the Americans With Disabilities Act, the Family and Medical Leave Act, and Workers’ Compensation”, on January 15, 2020.

Diane L. Dee, President of Advantage HR Consulting LLC, will be the expert at this session. Please log on to Globalcompliancepanel to register for this highly pertinent and valuable webinar.

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Each of these laws carries its own unique purposes and background in which it was legislated. At their core, this the purview of each of these laws:

  • The ADA: Aimed at prohibiting discrimination at the workplace
  • The FMLA: This law sets minimum leave standards
  • Workers compensation laws: Set the rules for the ways and extent to which employees who get injured at the workplace need to be compensated and rehabilitated and for minimizing employer liability.

There is significant overlap when these three laws are to be applied in practice, often in tandem. For example, most unscheduled and scheduled absences related to the illness of an employee or a family member, call for application of each, two or all three of these laws. When these laws are not implemented in the way they are supposed to be, the employers risk facing significant penalties and may have to take remedial actions that could include reinstatement, backpays, retroactive benefits, and damages of various kinds.

Participants of this webinar will gain a clear understanding of each of these laws individually, and more importantly, the way they interact with each other. They will learn how to integrate these aspects of these laws into company policies. The expert will also show how employers should make these policies known to the employees.

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About the speaker: Diane brings over 25 years of experience in the Human Resources arena. She has done HR consulting and administration in corporate, government, consulting and pro bono environments. Her organization provides comprehensive, cost-effective Human Resources solutions for small to mid-sized firms in the greater Chicagoland area. Additionally, Diane conducts webinars on a wide-variety of HR topics for training firms across the country.

 

Evolution of the Quality Management System

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An efficient and effective Quality Management System is the cornerstone for organizations in the regulated industries. Such a QMS signals to the regulatory authorities such as the FDA and others, that there are no lacunae in the completeness, accuracy, and consistency of an organization’s QMS.

It is not to satisfy the regulatory bodies alone that a robust QMS is necessary: it also gives the organization’s personnel the ability to meet quality requirements with consistency and accuracy. Accuracy of outcomes and quality of work are the results of such an assurance.

It is to help organizations in the regulated industries understand and get their QMS right, in the prescribed manner, that GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is organizing a long, six-hour webinar, on Jan 21, 2020.

GlobalCompliancePanel brings Susanne Manz, a well-known and highly accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, as the Director of this web seminar. To register for this highly valuable learning, please log on to GlobalCompliancePanel

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The regulatory guidelines state that the organization should “…establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured”. This makes it imperative for organizations to understand the exact requirements relevant to them and tailor them to their precise needs.

The consequences of having an inefficient QMS are obvious:

  • It can lead to serious compliance and quality issues, inviting 483 observations, Warning Letters, and even consent decrees
  • It can lead to inconsistent or poor product quality, which could result in non-conformances, complaints, and even recalls
  • The confusion and inconsistency it generates could lead to duplication of work and corrective and preventive actions, all of which can drastically increase the cost of quality

It goes without saying that utterly squandered time and money, and missed opportunities are the fruit of all this.

This marathon session will help participants understand the gravity of these issues and teach them how to avoid getting into these troubles, which can eventually destroy the business.

At this session, Susanne will explain the fundamentals of a sound QMS. She will show how to put in place an efficient and effective QMS with which the organization can meet its compliance objectives and improve its product quality, which brings in higher customer satisfaction and vastly enhanced business outcomes.

Core aspects of how to establish and maintain a QMS will be explained. These include the Basic Requirements, Management Responsibility, Quality Audit, Personnel, QMS structure, Quality Policy, Quality Manual and Standard Operating Procedures, Work Instructions, Forms, etc.

Participants will gain the following learning objectives at this session:

  • Overview of the Regulations
  • Essentials of an effective QMS
  • Essentials of an efficient QMS
  • Lessons learned and common Mistakes
  • Maturity modeling
  • Improvement tools
  • Best practices
  • Preparing for an FDA inspection

This webinar has the following agenda:

  • Regulatory Expectations
  • Lessons Learned from 483s and Warning Letters
  • Common Problems, Mistakes, and Warning Signs
  • How to Structure your QMS
  • Quality Policy and Manual Requirements
  • QMS Structure, Hierarchy, and Documents
  • Roles and Responsibilities
  • Key capabilities
  • Best Practices
  • Vision, Strategy, and Planning

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About the expert: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.