Medical Devices
Medical devices are now common in everyday life. The advancement of technology has brought us closer to devices that help in the diagnosis as well as the mitigation or cure of diseases. Today even our phone and watches are being used as medical devices. We have a long way to see how technology and software effects the development and the intended use of medical devices. Ultimately, we need to ensure safety and quality of all devices used in patient care.
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10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love
For a number of years now there has been an increasingly number of CGMP violations involving data integrity during CGMP inspections as observed by the FDA. One of the most important responsibilities of the industry is to ensure data... -
2-Hour Comprehensive Seminar on Measurement Systems Analysis
Attendees will also receive an Excel spreadsheet with the d*2 factors that are required for the average and range method, and another with data for the worked examples. These appear in some references that are named in the handout,... -
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21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation... -
21 CFR Part 11 Compliance for Electronic Records and Signatures
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11.... -
3 Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it... -
3-Hour Certification Course on Good Manufacturing Practices (GMP) – An Introduction
Good Manufacturing Practices (GMP) are a cornerstone of life sciences production. In fact, this decades-old regulation is so important that nearly everyone from discovery through product production should have a working knowledge of it. Despite this, even those directly... -
3-Hour Virtual Seminar on 510(k) and PMA Submissions Process
The FDA must review and process thousands of medical device submissions yearly. Shortening the time to market is a critical consideration of the medical device design and development process only after ensuring and affirming that the device meets its... -
3-Hour Virtual Seminar on Best Practices to Help you Pass an FDA Computer System Validation Audit
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.This webinar will help you understand the FDA’s current thinking on computer... -
3-Hour Virtual Seminar on Complaint Handling and Medical Device Reporting and Recalls
Despite best efforts, serious quality issues resulting in a recall can occur. Medical Device companies need to be prepared in advance to handle the difficult situation. This 6-hour virtual seminar will prepare you to understand the signals that trigger... -
3-Hour Virtual Seminar on Computer System Validation (CSV) vs Computer Software Assurance (CSA) – Following a Waterfall vs Agile Methodology
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance... -
3-Hour Virtual Seminar on Controlling Human Error in Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start... -
3-Hour Virtual Seminar on Design Control Essentials for Medical Devices
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.... -
3-Hour Virtual Seminar on Design Controls for Medical Devices
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.... -
3-Hour Virtual Seminar on Effective CAPA within a Device Quality System
This virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and... -
3-Hour Virtual Seminar on Effective Cleaning Validation Procedures – Best Practices
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as,... -
3-Hour Virtual Seminar on Ensuring Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists
Vendor selection is a serious process. Manufacturers are responsible for compliance with their selected vendors. Any violations from the vendors can cause serious problems for the manufacturers. Choosing a foreign vendor is no different than choosing a domestic vendor....
Industry professionals working as Contract Manufacturer or Sterilizer, foreign exporter, initial distributor, manufacturer, re-packager, re-labeler, re-processor of single use devices and specification developer all need to comply to the established regulatory proceedings of the Food and Drug Administration (FDA) in order to protect the user against the risk associated with the design, manufacture and packaging of medical devices. Webinar Compliance has been the front runner when it comes to training programs on medical devices. We regularly discuss and present courses on Medical device Classification, 510k submissions, Premarket Approval (PMA), Software as a Medical Device (SaMD), IVD’s (In Virtro Diagnostics) and cGMP (Current Good Manufacturing Practices). These medical devices training programs and medical device webinars would be essential to ensure that the specifications for the devices and manufacturing process are adequate and safe to produce. The ultimate goal of our medical device courses is to ensure industry professionals stay compliant as per the latest guidance issued by the FDA, EMA, WHO and other notified bodies.