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

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.

This medical device reimbursement webinar will discuss the similarities and differences in reimbursements between US and abroad. It will teach how to develop the domestic and international strategies for effective reimbursement.

In this session Mr. Shapiro will provide an overview of the history of the ISO13485, and the newly introduced changes. The Speaker will also discuss how the changes interact with regulatory requirements, and how to face the new changes. The webinar will focus on key provisions and considerations when establishing a QMS as per the ISO13485: 2016, and identify pitfalls that should be avoided.

This webinar will provide valuable insight to design assurance and quality assurance engineers looking to simplify or condense design development activities into one document for easier traceability. This webinar is also ideal for startup companies who are unfamiliar with FDA design development regulations and are looking for a place to start in their path towards compliance.