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

Detailed analyses of the sections of the QSR design control regulations that have requirements not present in the ISO 13485:2003 standard. Many companies are confidant that their ISO 13485:2003 design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue.

This Management Controls Under QSR and ISO 13485 training/webinar will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system and quality plan, and of course all aspects of management reviews.

This Quality Planning training/webinar will define the Quality policy and plan with the help of procedure, Manual and templates where manufacturer decides how to apply these regulatory guidelines in developing a plan that consistently delivers high quality products and services.

This Residual Risk and Risk Acceptability webinar/training in medical devices will discuss how to meet this requirement and also how to determine what disclosures of risk need to be made in the instructions for use of the medical device and Proper evaluation of overall residual risk and the acceptability of this risk.

This Device Manufacturing webinar provide a understanding of the GMP and Quality requirements for the design, manufacture, storage, distribution, and installation of Medical Devices including the requirements for complaint handling, and servicing.

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.

This statistical Design and Analysis of Experiments webinar will introduce DOE and process modeling.

This Risk Management webinar/training will describe enhancements to these techniques that can improve your relationships with customers and regulatory agencies, resulting in a reduced number of surprises during inspections.

This Design Controls Webinar will provide a overview of all the steps involved in design controls and explain and clarify and state specific requirements in the regulations.

This Viral Validation webinar provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation.

This Risk communication webinar/training will review the types of risk communications that take place regarding medical device failures at both pre- and post-marketing stages in the lifecycle of medical devices.

Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation. Risk Management Activities can lead to reduced cost and reduced time to market when conducted during the Design Input phase of product development. Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation.

This Designing Viral Clearance training discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing.

This Six sigma training in Medical device will demonstrate the value of using DFSS principles in developing such devices by identifying critical design, production and distribution parameters that affect the performance of the finished device. Design for Six Sigma (DFSS) can be used to design, manufacture and sell high quality, defect-free, safe, effective devices that meet the intended use while also generating healthy profit margins for the company.

This Auditing training will show you how to audit your compliance and ethics program and how to Evaluate the Design and Operating Effectiveness. Organizations are exposed to governance, compliance and ethical risks daily. Coupled with the current economic, regulatory and social climate, these risks have propelled corporate governance, compliance management and integrity to a top business priority

In this Design Input training will define design input, review robust requirements development, assess the impact of User needs Vs Patient needs and discuss options for timing your design reviews. During this seminar, we will complete a sample Design Input requirements document that you can use as a guide for writing your own requirements

This FDA compliance training will review the FDA Software Standard "General Principles of Software Validation". The process that FDA investigators use relative to software failure investigations will also be discussed.

This statistical process control training will provide an overview of statistical process control (SPC) describe various types of control charts and how they can be used for trend analysis, defect reduction, product capability assessment. Quality, safety and efficacy must be designed into a product. Quality cannot be inspected or tested in the finished product.

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 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.