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

This webinar will provide valuable assistance to all regulated medical device companies who implement internal audit programs to comply with US and international regulations. This presentation will provide an understanding of how to integrate US, Canadian, European and Japanese regulations into an effectively documented and implemented internal audit program.

This webinar will provide valuable assistance to all regulated companies, a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. This session will discuss the importance, requirements, and elements of a root cause-based CAPA program, as well as detailing the most effective ways to determine root cause and describing the uses of CAPA data.

This webinar will provide valuable assistance to regulated companies which employ regulatory affairs associates, clinical specialists, internal auditors, audit managers and personnel of JPAL-regulated medical device or IVD companies. A comprehensive audit of relevant clinical investigations is now expected to determine if the clinical trials and clinical trial systems are effectively documented and implemented.

In this webinar, we will review basic FDA expectations for evidence of adequate analysis and testing to identify the severity and likelihood of use errors, and validation of risk mitigations through usability testing with representative users. As applied to the overall Design Controls process phases, will be presented.

This webinar will provide valuable assistance to internal auditors, audit managers and personnel of regulated medical device or IVD companies. This presentation will provide an understanding of the tools of risk management and how to integrate risk management into an effective internal audit program.

The workshop will provide guidance on the roles and responsibilities of each functional area in the company and how they relate to each other. Each company must demonstrate full implementation of the quality system by providing appropriate training and re-training when necessary, for its employees.

This webinar will provide valuable assistance to all medical device and IVD companies that must comply with domestic and international regulations for their quality systems. Most notable of these would include USA (21CFR820), Canada (CMDR + ISO 13485), Europe (MDD Annex II.3 + ISO 13485) and Japan (JPAL Ordinance 169 + ISO 13485).

In this webinar, essential tactical tools will be discussed in detail with examples of when to apply one and not another The tactical tools will be presented in the framework of an overall regulatory strategy so you can see the “forest for the trees” and effectively communicate your plan to senior management, the development team, and most importantly, to government regulators

This session will introduce advanced control charting for multiple stream processes. We will also introduce control chart analysis and how to select the correct control chart and interpretation and reaction to control chart signals.

The presentation will review the complete requirements for Risk Analysis and give an example of how a company can easily create a Risk Analysis in full compliance with the standard. The information will assist in meeting various national and global regulatory requirements for medical devices.

An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry.

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 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 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.