Industry Update – China's Evolving Medical Device Regulations

is being presented by Seth J. Goldenberg, President, of Asia Pacific Bio Intelligence and airs on Tuesday, March 13th, 2012. For more details, or to register please visit our site at www.fxconferences.com

China is constantly improving its regulatory statutes and bringing them in line with other international regulatory bodies, and 2011 was a banner year for regulatory updates from China’s State Food and Drug Administration (SFDA). Significantly, the SFDA started its scheduled enforcement of medical device good manufacturing practices (GMP) regulations, and it also issued new rules that increase oversight of medical device adverse events and recalls. The device approval process was also modified to ease registration by not requiring clinical trial data from companies domestically producing Class II devices, which is very similar to the U.S. FDA 510k process. These changes will have broad implications in the short and long term for domestic Chinese firms and multinational firms already in or considering entry into China.

This audio conference presentation provides an update on various aspects of China's medical device regulations, focusing on recent changes and exploring what they mean for device manufacturers.

QA Oversight of Contractors

is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc and airs on Tuesday, August 24th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com

Managing contractors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.

This audio conference discusses what a quality agreement is and how to use it as a tool in managing your contractors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.

QA Oversight of Vendor Management

is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Wednesday, March 17, 2010. For more details or to register, please visit our site at www.fxconferences.com

Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.

This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.

The ABCs of FDA: Regulatory, Fraud and Abuse Issues

More and more companies are venturing into medical devices, drugs or biologics in an effort to diversify or to promote new biotechnologies. At the same time, the United States government is taking a more active role in regulating the manufacturers, providers and payers in the healthcare industry. The collision of these two trends – increased interest in marketing healthcare products along with increased government involvement in regulation and enforcement – require companies to attain FDA regulatory compliance and prevent fraud and abuse violations in order to be successful in this industry and avoid multi-million dollar fines and penalties.

In this audio conference, the speaker addresses the basic things that people and companies need to know about dealing with the FDA and succeeding in the life sciences industry.

The ABCs of FDA: Regulatory, Fraud and Abuse Issues was presented by Bethany Gilbert, with Hodgson Russ LLP and aired on 2008-05-15. For more details, or to download this event please visit our site at www.fxconferences.com

QA Oversight of Vendor Management

Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.

This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.

QA Oversight of Vendor Management is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, October 13, 2009. For more details or to register, please visit our site at www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

Combination product manufacturers are faced with a major challenge to implement a quality system that complies with applicable FDA Good Manufacturing Practices (GMPs) and Quality System Requirements (QSRs). For 10 years, FDA has been progressively developing regulations for this complex area, yet has provided very few formal guidance documents to help manufacturers.

In this audio conference, you learn how to navigate the regulations to develop effective plans for combination products. Linda Alexander gives you specific examples of current FDA expectations and accepted practices, and teaches you how to customize and apply them to comply. Explore the history of combination approvals in the US, case studies, and important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? was presented by Linda Alexander, CEO and Founder, with Alquest and aired on 2008-09-18. For more details or to download this conference, 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 discusses 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 also examines 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 Thursday, Sept. 18, 2008 by Linda Alexander, CEO & Founder, of Alquest. For more information, please visit our site www.fxconferences.com

CE Marking: 7 Steps to Getting Started in Europe

With a population approaching a half-billion people, the EU represents arguably the most lucrative market today. However, before any medical device company can sell in Europe, it must first obtain the CE Mark. The process of obtaining approval to affix the CE Mark to your product differs significantly from the US FDA system.

This presentation covers the basic steps companies need to follow in obtaining the CE Mark, including a discussion about ISO 13485:2003 and how it differs from FDA Good Manufacturing Practices (GMP), issues related to language translation and labeling, creation of a Technical File and how this differs from the FDA 510(k) application, dealing with Notified Bodies, selecting an Authorized Representative and an overview of the costs and timelines involved in achieving certification.

CE Marking: 7 Steps to Getting Started in Europe was recorded on 2007-04-03 and is now available for download 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