Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

This medical device reporting webinar will guide you to understand best practices to assess your current MDR efforts and implement changes to match the FDA's new guidance recommendations. Attendees will learn the current regulations that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for any device-related adverse events and certain malfunctions (investigational study reporting).

This webinar will help understand data analysis requirements for QSR, the techniques to identify problems, analyze cause and action plan preparation to avoid FDA inspection and MDSAP audits. It will help you understand how to pick right data analysis techniques from ISO/TR 10017:2003 and how to analyze data in excel.

This webinar will highlight the changing circumstances with respect to software regulations and FDA’s approach from a regulation to voluntary standard. How to understand the qualifications and terms of participation to clear its software for marketing, what to do in case of cybersecurity intrusion and how to update regulatory program as mobile apps are removed from FDA’s regulatory oversight.

This webinar will give an understanding of various processes and compliance requirements for US market entry by non-US medical device manufacturer. It will teach how to comply with pre-market requirements, how to get submission & product clearance/approval, what are various activities to be done post market entry of products (surveillance, reporting, audit, correction & removal).

This webinar covers the central role of CAPA for the FDA, challenges in building an effective CAPA system, gives a comprehensive understanding of a CAPA process which is highly effective and sustainable, becoming a tool for continuous improvement. It will discuss capturing and assessing potential CAPA’s, using risk-based assessment, documentation, determining true root cause, how to take preemptive preventive action and using metrics for long-term improvement. The course will also discuss potential changes as FDA considers integration with ISO 13485.

This Water system compliance training cover all these issues and more so that the attendee can have a better appreciation of the endotoxin test, a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water.

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

The management responsibility section of the QMS is one of the most important parts because it sets the tone for other sections. If you are involved in any aspect of management responsibility, then you need to understand how to set up the system as well as what can go wrong. This presentation provides you with an explanation of the issues, implementation tools, and illustrations of problems that could arise.

The objective of the Webinar is to teach participants how to use ISO 10993-1 and FDA guidance to establish a proper biological safety evaluation plan, including how to document and implement their plan. It will also cover how to properly complete your biological evaluation report including biological safety assessment as required by domestic and foreign regulatory submissions.

Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately.

This GLP webinar training will discuss the various US and International GLP regulations and the strategies to comply with them. Get practical recommendations from industry leading expert Dr. Ludwig Huber.

In this webinar our expert Dr. Mike Colvin will discuss how to use ISO 14708-3 standard which is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system and contains particular requirements to ensure basic assurance of safety for both patients and users.

This training will help you understand FDA expectations for reduced testing of Pharmaceutical & Medical Device components and will develop your confidence in maintaining control of supplier quality.

This regulatory reporting webinar will discuss the importance and characteristics of a regulatory reporting system. It will also explain how to create processes to work seamlessly with it along with the planning and designing the system to meet the requirements of complaint and adverse event reporting accurately and timely.

This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity

This webinar will discuss current medical device registration requirements in Brazil and recent regulatory changes. Topics to be discussed are Company Licensing, risk assessment, how to get regulatory clearance,GMP certification, INMETRO certification, govt fees etc.

This course on 510K documentation for software or software enabled device will detail what Medical Device companies need to know what Software Specific documentation needs to be prepared for successful 510K submittals to avoid delays or denial of the 510K approval. it will discuss key to comply with IEC62304, FDA guidance with in software development and verification/validation process.

This CAPA evaluation, implementation and integration webinar will discuss FDA regulatory requirements, how to evaluate your CAPA system, how to integrate with QMS and the best practices approach to initiation, evaluation and implementation of CAPA system along with discussion about CAPA documentation requirements.

In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process.

This webinar provides initial guidance on how to build a cybersecurity recovery program that includes FDA CAPA elements. The training will address how to prepare a firm's staff for cybersecurity problems. Remember, people carry the biggest "open door" for a hacker. You can use FDA's optional follow-up options. Finally, you can take away a basic checklist that a cybersecurity audit team should include in their program. It is a start from which you can further develop and refine a cybersecurity program as you gain experience.