We’ve assembled experts from the legal, clinical and regulatory fields to discuss... information that will help provide a competitive edge to those in attendance.
Wheat Ridge, CO (PRWEB) November 19, 2012
Design Control: Best Practices in a Changing Regulatory Environment,
Co-sponsored by Hogan Lovells LLP and CPC Clinical Research
Reglera, a Dohmen Company, and leading provider of quality assurance and regulatory affairs consulting services to medical device and human cellular tissue companies, will co-host a conference titled, Design Control: Best Practices in a Changing Regulatory Environment. The two-day conference, co-sponsored by international law firm, Hogan Lovells LLP, and clinical research organization, CPC Clinical Research, will be held January 14-15, 2013, at The Golden Hotel in Golden, Colorado.
“Creating a design control process that meets the technical and regulatory requirements required today in an efficient manner is extremely challenging,” said Reglera President, Clay Anselmo. “We’ve assembled experts from the legal, clinical and regulatory fields to discuss best practices and provide interactive training on subjects including -- understanding current FDA positions, product liability, enforcement trends, clinical studies and obtaining clinical data –information that will help provide a competitive edge to those in attendance.”
Anselmo said the conference will examine the Design Control process from the quality assurance and product development perspectives, emphasizing a balanced approach to producing world-class products that meet regulatory requirements. Design Control topics such as software and human factors will be discussed with best practice recommendations.
The conference is designed for key individuals responsible for the quality and regulatory compliance of new product development; including developers, quality engineers, regulatory associates, and managers from Quality Assurance, Regulatory and Product Development organizations.
To register and view the agenda, visit http://www.reglera.com/rdcu-agenda. For more information call Jo Palumbo at 303.952.7244 or email palumboj(at)reglera(dot)com.
About Reglera: Based in Wheat Ridge, Colorado, Regkera, a Dohmen Company, provides best practice compliance and quality assurance services to more than 500 hundred medical device and human cellular tissue companies. With one of the largest consulting staffs in the industry including hundreds of experts in device and tissue located in the US and Israel, Reglera has helped both small start-ups and global corporations accelerate growth and profitability with comprehensive consulting and outsourcing services. For more information regarding Reglera services visit http://www.reglera.com or contact Brian Tucker at 1.800.341.4255 or info(at)reglera(dot)com.
Founded in 1858, Dohmen is a privately-held, Life Science Services Company, focused on creating a more efficient, affordable and accessible healthcare supply system. As the trusted partner to more than 600 Biopharma, Medtech and advanced therapy innovators, Dohmen propels start-up, mid-tier and Fortune 500 companies with support services that span the commercialization continuum from pre-approval regulatory consulting to in-home patient services. With a tradition of innovation that spans over 155 years, we’re driven by the desire to reduce cost and complexity within today’s healthcare system, using a progressive model that connects life science companies with the patients they serve.