November 15 Webcast on Dealing with FDA’s Changing Compliance Environment

 It's no secret that FDA is forever changing. The agency has said it will take new initiatives to place greater emphasis on quality operations and on compliance during quality system inspections. An upcoming event sponsored by Epicor and mdi Consultants offers in-depth analysis and discussion.

A FREE event will take place on November 15, at 2 pm ESTDealing with FDA in a Changing Compliance Landscape aims to help medical device regulatory personnel, the company's quality team, and product life cycle managers tackle the challenges facing compliance issues in an ever-changing compliance landscape.

Experts Alan Schwartz and Christine Hansen will discuss what FDA's new compliance posture means for the medical device industry. Attendees will receive tips on how to respond to FDA 483s and how to prevent getting Warning Letters. They will also get practical advice on Agile technology, traceability for end-to-end systems, and eliminating wasted processes and procedures.
 
 

About the Speakers
 
Alan Schwartz, mdi Consultants, Inc., has 40 years of FDA regulatory experience. He has been providing strategic planning on FDA regulatory compliance issues since 1978. Prior to mdi, Alan was a supervisor of field operations for FDA. He has been an invited speaker on FDA policy and issues both in the US and internationally.
Christine Hansen is manager for product marketing, manufacturing and supply chain management at Epicor Software Corp. She joined Epicor as part of the DataWorks Corporation merger in 1995. In her current position, Hansen is responsible for the product marketing and direction of various Epicor product suites. 
 

About the Event

UBM CanonMD+DI, MPMN, Qmed, Plastics Today, Packaging Digest, PMPN, and Design News and are proud to kick-off their “MedTech Trends in 2013” Webcast Series.  The first in the series, sponsored by Epicor & mdi Consultants, will focus specifically on Dealing with FDA in a Changing Compliance Landscape and offers in-depth analysis and discussion from experts in the industry.