The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
Excel® Applications are widely used in laboratories, offices and manufacturing e.g for data capture, data evaluation and report generation. Regulations such as FDA'sGxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to control, validate and use Excel® requirements can be met. Attendees of this webinar will get all details on how requirements can be met.
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have procedures in place that describe the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered 'approved.' You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain 'approved.' You may never have to pay a visit to your supplier if you have a good supplier control program in place.
This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations. The deviation process is explored and evaluated and examples are given to demonstrate the best way to handle deviations and subsequent CAPAs. Attendees will have the opportunity to interact and ask questions about best practices regarding both devotions and the CAPA process. Reasons for having a robust deviation process are given with examples.
Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.
Learn that treating your patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs form unnecessary surgeries and faster rehabilitation. However one must know how to get the proper licensure and know the Federal & State Guidelines. You must know how to prepare to deal with the insurance companies that constantly deny every claim they can for any reason possible.
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. This webinar can help you create a design control process that is a competitive strength for your company.
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.
DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertising methods and messages. The days of looking at text alone for a magazine insert are long gone. You should pay attention to the components of your advertising in mass media, such as volume; images; information prominence and conspicuousness; speed of the message subliminal messaging and "the take away message." This means you need to understand what each component of the advertising attempts to accomplish and then evaluate the integrated message, i.e., the "take away." The difficulty is that this broad horizon of factors gives the FDA abundant opportunities to say that you have misbranded your product. Hence, it is illegal.
No one disputes the importance of proper training for all employees in a medical device company. Yet defining needs for all employees, either individually or by position description, can be a real challenge. This is especially true for start-up and other small medical device companies, or rapidly growing companies. Specific FDA training requirements will be presented. Techniques for needs assessment and record keeping will focus on in-house training while also covering how experience and outside training can be integrated into this training. Although this presentation will focus on what works for small and medium sized companies, the principles are equally applicable to larger companies.
This presentation explains the requirements for control of inspection, measuring, and test equipment. This includes a calibration program that satisfies FDA's Quality System Regulation (QSR), ISO 13485:2003, and ISO 13485:2016. The presentation defines accuracy, precision, and traceability. After explaining the concepts, it moves to an analysis of the requirements from each of the quality management standards. Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. In addition to the specific requirements, the presentation includes examples from FDA Warning Letters, information from FDA's Quality System Inspection Technique (QSIT), and the Medical Device Single Audit Program (MDSAP) Audit Model.
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
This webinar will begin by first defining combination products in terms of the complexities that combination products present to the organization from a device and pharma/biologic standpoint. The webinar will then move on to the regulations governing how combination products are regulated. Various scenarios will be presented that will discuss how and which regulations apply depending upon the facility and the device. A job aid will be provided as a webinar enhancement that will make the complex process of regulation application simple to understand.
This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control.
The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
Can a Doctor of Chiropractic really bill Medicare for DME? It is not if but how. Explore the strategies to be able to provide your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs by preventing unnecessary surgeries. Learn how to get the proper licensure and how to be compliant with all Federal & State Guidelines.
All manufacturers, system integrators and importers of lasers or laser containing products must comply with FDA regulation 21CFR1040 with very few exceptions. This is accomplished by a self-certification of the device typically using FDA form 3632 Guide for Preparing Product Reports for Lasers or Products Containing Lasers. The completed form and supporting data is then sent to the Center for Devices and Radiological Health (CDRH) and a document tracking number, commonly known as an accession number, is issued. This webinar will provide guidance as to the best practices for generating this form 3632 document. It will include recommended methodologies to test and record the emission output and interlock performance of the laser systems.
Though they may appear bewildering and bureaucratic, today's quality standards for medical device software arise from, and focus on, a concern for safety. Key areas the standards address are overall quality process, development lifecycle, risk management, and usability. The quality system standard (ISO 13485) and the Quality System Regulation (21 CFR part 820) set out what an organization must achieve, but don't specify how to go about achieving it. Recent changes in the international standard, and in the European medical device quality framework, will be tightening expectations. The software development lifecycle standard (IEC 62304) and the FDA's guidance (General Principles of Software Validation) state the processes expected for software development within a quality system environment, tied to a risk management process. However, no standard can dictate how to write good software.
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use.
Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording. This 60 min Webinar will discuss the proper timing and wording to use for the 483 response to put your company in the best position with the FDA. FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given. Warning Letters and responses are discussed and the implications of both a good and poor response to a possible Warning Letter are given. The standard format of the 483 response is given along with an explanation there of.
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.
This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing compliance risk.
When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rather than contradict the Agile manifesto.
Learn how to provide your Medicare patients with Durable Medical Equipment to maximize patient clinical outcomes while developing a great revenue stream. The key is how to be legally compliant. Understand the process in how to get the proper licensure called DME PAN # and know the Federal & State Guidelines.
In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective. We will also cover where else in your quality management system root-cause analysis can be used. Learn how Root cause analysis can be used in process control.
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Additionally, the application of risk management to a CAPA program will be reviewed, and a specific risk management system explained.
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Corrections and removals, C&R, can be a confusing topic because it is intertwined with design changes, device improvements, and recalls. In addition, C&R includes some complicated technical definitions that could create exemptions to reporting. However, misapplication can result in a Warning Letter. The regulations are not always clear, especially when contrasted with Part 7, which sets the rules for FDA's involvement in recalls. The definitions of the terms don't even agree.
Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.
Learn that treating your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs. However one must know how to get the proper licensure and know the Federal & State Guidelines.
Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation. The presentation examines elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485:2016.
The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit. Domestic and international regulations actually assist in this endeavor, by setting forth the requirements to assure a process is consistent, and that it yields output that is both safe and effective. These requirements are applicable to both automated and manual processes. This webinar explains the regulatory requirements for process validation, and also includes definitions and application of applicable terminology, and hints and recommendation for the more common types of process validation. Also covered will be the validation technique used for processes that are already in place.
During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.
The Agile approach is well established in other industries adoption of Agile in medical device development has been increasing in the past five years. Experience is showing that both quality and safety are improved when the development team is agile, and that regulatory requirements can still be met. This session will delve into several key areas for applying Agile in the medical device context, including:
To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to verify training effectiveness, and how to document training so that it is readily available for review (by managers, auditors or inspectors).
Process knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each critical step of the process operation and the overall process results based on statistical database for each batch of that product code. Strategies for process control and operator activities can be designed to reduce variation, adjust for variation during manufacturing and reduced possibility for operator error, as well as an overall blend to manage critical process parameters (CPPs) as well as the original process limits which typically change after the initial validation as well as the trend analysis for each critical step of the process.
Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic.
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.
This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. The difference between pre release and post release change control will be explained. Methods to control the transfer and approval of changes between the company and its suppliers or contract manufacturers will be explained. Change control forms will be provided and described in detail.
FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters.
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools. In this seminar we will explain in detail the process of conducting a hazard analysis.