This 90-minute webinar will help you understand the 510K process including some history about 510ks versus PMAs and give you the necessary information to know when to file a 510k, as opposed to a PMA, or to not file any 510K of a new or existing medical device.
This food safety webinar will discuss the currently accepted food safety practices and how the the newly evolving system for food safety is about to be put in place.
Quality Assurance (QA) and Good Manufacturing Practices (GMP) play a critical role in ensuring the safety, efficacy, and quality of drugs during their production. In the pharmaceutical industry, QA refers to the systematic processes and procedures implemented to guarantee that drugs meet the established standards and regulatory requirements. GMP, on the other hand, encompasses a set of guidelines and regulations that govern the manufacturing, testing, and quality control of pharmaceutical products.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible.
This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.
This webinar will provide an overview of FDA and Health Canada, their organizational structure, regulatory and compliance oversight, agency interactions and implications for your organization and your regulatory and compliance obligations.
In a rapidly evolving medical landscape, the significance of meticulous and effective technical writing cannot be overstated. Join us for a enlightening 3-hour webinar, "Technical Writing for Medical Devices: Writing Effective 510(k), PMA, and De Novo Submissions," where we will delve into the intricacies of crafting comprehensive and persuasive regulatory submissions. From the foundational understanding of regulatory pathways to the fine art of presenting clinical data, this webinar will equip you with the tools and knowledge necessary to excel in this critical aspect of the medical device industry.
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
This presentation looks at the entire supply chain picture and the physical flow of materials and services, the flow of information, the flow of money, and the flow of people. Participants will review a successful supply chain process versus an unsuccessful process. The presentation will explore the benefits and challenges of this end-to-end process.
This webinar will look at some of the most prominent operative factors and define the norms in the Responsibility and Accountability architecture of management, namely the Supervisor.
Because most business in the US is classified as ‘small business’, very often the luxury of having a system or process for supervisory selection and development is informal, at best. We will describe some of the easiest and most effective ways to bring a supervisor up to speed on their responsibilities. Some of these techniques are surprisingly simple.
This FMEA (Failure mode and effects analysis) training will cover the Joint Commission requirements for conducting a proactive risk assessment using the FMEA methodology.
This Failure Modes and Effects Analysis (FMEA) Webinar will give an overview and elements of an FMEA. The analysis of data outputs will also be discussed.
PSURs are pharmacovigilance and device adverse events documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization in the EU. The purpose is to harmonize and strengthen benefit-risk review of medical products across the European Economic Area.
Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. These needs smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.
Attend this webinar if you are faced with the task of having to register a product worldwide and need to think about the most sensible and efficient way to do so. The correct order of the countries and the provision of the documents and what the differences are between the various technical dossiers of the countries are often decisive here.
Attend this webinar to understand, what are the requirements of article 32 EU MDR 2017/745 for implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance (SSCP). Your implementation needs smart ideas to reach the right level to pass the quality management audit and technical file audit by your notified body or authority inspection.
This course offers practical approaches and tools to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.
This webinar will help you identify factors that cause delays as patients progress through their stay and how to correct these barriers to care. Learn the most streamlined ways in which to integrate avoidable delay management into your day and with all the members of the interdisciplinary care team. Finally, it will review some examples of report cars that can be used to understand the data you have collected.
This instructor-led live webinar will discuss the established approach of Pharmaceutical Quality Management as it relates to the relationship between risk management and the pharmaceutical regulations that govern the business.
