Good Auditing Practices for EU Notified Body Audits

is being presented by Theo Nusselder, Founder & Director, of cePartner4u and airs on Tuesday, March 30, 2010. For more details or to register, please visit our site at www.fxconferences.com

Are you ready for a Notified Body audit? The European Medical Devices Directive requires that manufacturers of medium- and high-risk devices apply for an assessment of the manufacturing process and the technical documentation. The manufacturer is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market, regardless of whether these operations are carried out by the manufacturer or outsourced to a third party. The quality system must ensure that the products conform to the requirements of the Directive at every stage, from design to final inspection.

The Notified Body must audit the quality system to determine whether it meets the requirements, and the auditors have thorough knowledge of the rules on the inspections. Such rules are given in ISO requirements for audit and certification of management systems (ISO 19011:2002) and GHTF guidelines for Regulatory Auditing of Medical Device Manufacturers (GHTF/SG4/N28R4:2008). In this audio conference presentation attendees learn how to use these rules as a guide to Good Auditing Practice for the Notified Body assessment and CE-certification procedures.

Points to Consider when Presenting Documents for an FDA Inspection

It used to be that all controlled documents were stored as hard copy in a document center where they would be signed out for presentation to inspectors. These days, records are stored in a variety of computerized systems. They are typically printed out in the last minute and with minimum review. When these records are then made available to inspectors, they are often incomplete and inaccurate.

In this audio conference, our speaker provides an understanding of offical records, explores different strategies, and explains how to prepare your records for an FDA inspection in a more complete and accurate manner.

Points to Consider when Presenting Documents for an FDA Inspection is being presented by Ronald Eisenwinter, Quality & Regulatory Consultant and airs on Tuesday, February 16, 2010. For more details or to register, please visit our site at www.fxconferences.com

Ensuring GCP-Compliant Trials with Clinical Quality Audits

In the race to start and complete clinical trials, securing investigator, CRO, and sponsor GCP compliance can be an overwhelming task. Clinical quality audits are an essential tool in ensuring that clinical research is conducted in accordance with GCP requirements. Given the pressures of executing efficient and expedited research, including audits in your overall clinical investigative plan increases the quality of research data and protects sponsor investment. Addressing compliance issues early and consistently, through corrective and preventative action, enhances data integrity and the quality of the overall clinical trial.

This audio conference provides attendees with tips for an efficient and effective clinical audit strategy, along with tools to assist in conducting GCP audits of clinical investigators, clinical research organizations and sponsors.

Ensuring GCP-Compliant Trials with Clinical Quality Audits was presented by Carol Houts, Director of Regulatory, Quality and Safety, with Pleiad Inc. and aired on 2008-10-09. For more details or to download this conference, please visit our site at www.fxconferences.com

Ensuring GCP-Compliant Trials with Clinical Quality Audits

In the race to start and complete clinical trials, securing investigator, CRO, and sponsor GCP compliance can be an overwhelming task. Clinical quality audits are an essential tool in ensuring that clinical research is conducted in accordance with GCP requirements. Given the pressures of executing efficient and expedited research, including audits in your overall clinical investigative plan increases the quality of research data and protects sponsor investment. Addressing compliance issues early and consistently, through corrective and preventative action, enhances data integrity and the quality of the overall clinical trial.

This audio conference provides attendees with tips for an efficient and effective clinical audit strategy, along with tools to assist in conducting GCP audits of clinical investigators, clinical research organizations and sponsors.

Ensuring GCP-Compliant Trials with Clinical Quality Audits is presented by Carol Houts, Director of Regulatory, Quality and Safety, with Pleiad on Thursday, Oct. 9, 2008. For more details or to register. please visit our site www.fxconferences.com