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

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.

The course is designed to review critical elements of the new regulations and is suitable for clinical, regulatory and quality leaders. The course is suitable to anyone who is new to Medical Devices, in addition to those who would like to further their working knowledge of current requirements.

In this CAPA webinar, learn various regulations governing Corrective and Preventive Actions (CAPA) and how organization should collect information, analyze information, identify, investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.

This FMEA webinar will discuss how to use FMEA as a tool for risk assessment and how to make it an integral part of risk management. What are the harmonized standard of risk assessment of medical devices under MDD and how to use it in design control risk management.

This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.

This Medical device complaints handling webinar will discuss the best practices of complaint handling and how to include it in your CAPA program and how to apply risk management to the complaint handling system.

This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.

Learn how to design regulatory strategy for your medical device to expand your business in Brazil & Argentina. Get insight in to regulatory policy and implication for medical device and the key issues in medical device laws of Brazil and Argentina.

This webinar will teach you the key elements on how to build a winning MDR team and its process. This webinar will discuss the best practices in complaint handling, screening & evaluation for reportability, employee training and expectations which helps the medical device manufacturers in building an effective MDR Reporting and stay abreast of regulatory changes and lead key personnel to stay current in training and compliance.