Driving Your Quality System With Effective Management Controls

is being presented by Vinny Sastri, President, of Winovia LLC and airs on Thursday, October 6th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com

Over the last five years, management controls made up approximately 15% of all warning letters by subsystem annually. There is a scarcity of information and presentations on management controls even though it is the most important aspect of the quality system. This presentation will detail the importance of management controls in driving a quality organization.

It is up to management to ensure that an effective and sustainable quality system is implemented appropriate to the organization’s products and processes. Management should set the vision, strategy and goals, and this should be communicated to everyone within the organization. Leading by example and focusing on quality are keys to success. This audio conference presentation looks at how effective management controls lead to successful quality-centric and profitable organizations, as our speaker shares organizational best practices in this key area.

Implementing a Quality Management System: ISO 13485

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and regulatory requirements. One of the main objectives of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. It includes many of the elements of ISO 9001 but excludes some aspects not appropriate as regulatory requirements. ISO 13485:2003 is applicable to all medical device manufacturers, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, or if “product realization” (Clause 7) is not applicable, these can be excluded from the quality management system. However, organizations claiming conformity with ISO 13485:2003 must reflect these exclusions. The processes required by ISO 13485:2003, which are applicable to the medical device(s) but are outsourced, must be accounted for in the organization's quality management system. ISO 13485:2003 is used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.

This conference looks at the requirements of ISO 13485:2003 and some practical aspects of setting up a quality system for medical device manufacturers.

Implementing a Quality Management System: ISO 13485 is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, October 15, 2009. For more details or to register, please visit our site at www.fxconferences.com

Implementing Quality Systems to Enhance Profitability

Quality is a perennial buzzword, both within the life sciences and in other industries. But how does a company go about determining exactly what sort of system is needed, and making sure it is effective? In this audio conference, our speakers provide insight into the use of quality systems to improve profitability in both FDA-regulated and non-regulated industries. The presentation looks at the key points to consider, starting with what is a quality system and how can it improve performance?

The presentation also looks at the design and implementation of quality systems, and the return you can realistically expect to gain from putting a properly designed system in place.

Implementing Quality Systems to Enhance Profitability is being presented by Ralph W. Donnelly & Frank Mark, President, R. Donnelly & Associates / President, The Polmarc Group LLC and airs on Thursday, September 17, 2009. For more details or to register, please visit our site at www.fxconferences.com

3 Steps to Successful Translation Management

Translators have been around since the time of the Babylonians, yet the US translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but pharmaceutical, device and diagnostics companies need a true partner that can help them effectively manage the translation process.

This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.

3 Steps to Successful Translation Management was presented by Andres Heuberger, President, with ForeignExchange Translations and aired on 2009-01-30. For more details, or to purchase a download of this event, please visit our site at www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

For 10 years now FDA has been progressively developing its regulation of the complex product area known as combination products, with very few formal guidance documents for industry. Combination product manufacturers are faced with the challenge of deciding how to implement a quality system that is compliant with applicable Good Manufacturing Practices and Quality System Requirements.

In this audio conference, our speaker will discuss the applicable guidance and current thinking on meeting FDA expectations for combination products, sharing specific examples of accepted practices and how FDA regulations and guidance are currently being applied. The presentation will also examine the recent history of combination product approvals in the US, as well as important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? is presented by Linda Alexander, CEO & Co-Founder, Alquest, Inc. For more details, please visit our site www.fxconferences.com