Reglera Design Control University September 27-28, 2012 in Golden, Colorado

Online, July 19, 2012 (Newswire.com) - Reglera LLC is pleased to announce a conference titled "Design Control: Best Practices in a Changing Regulatory Environment" in association with the law firm of Hogan Lovells LLP and the clinical research organization CPC Clinical Research. This conference will take place for two days in Golden, Colorado, September 27-28, 2012.

Design Control formalizes the product development process by creating the control mechanisms and execution evidence necessary to show adherence to regulatory requirements and good engineering practices. Creating a design control process that meets the technical and regulatory requirements in an efficient manner is a challenge for many medical device companies. Today's regulatory and market environments require a greater level of awareness and flexibility in meeting the compliance requirements. Reglera is pleased to assemble a group of experts from the legal, clinical and regulatory fields to discuss best practices, which includes Hogan Lovells and CPC Clinical Research.

The conference will feature technical, legal and clinical experts presenting topics critical to successful design control implementations in support of regulatory submissions and overall compliance. Interactive training on current best practices and implementation will be led by Reglera; training and discussion on current FDA position, product liability, and enforcement trends will be led by Hogan Lovells; and, instruction on the types of clinical studies and best practices in obtaining clinical data discussions will be led by CPC Clinical Research.

The Design Control process will be examined from both the quality assurance and product development perspectives with the recommendations for a balanced approach that produces world-class products in a regulatory compliant fashion. Finally, complex 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. These individuals include developers, quality engineers, regulatory associates, and managers from Quality Assurance, Regulatory and Product Development organizations.

Registration information is available on Reglera's website, www.reglera.com, to secure your attendance.

About Reglera
Based in Wheat Ridge, CO, Reglera is one of the largest and fastest growing regulatory consulting and outsourcing companies in the world. Specializing in the medical device and human tissue industries, Reglera provides companies with products and services that cover a wide variety of technical and support areas. Whether you are developing a new product, need assistance with the FDA, or are simply trying to comply with the myriad of regulations and standards, Reglera's products and services will accelerate your success and profitability. Reglera has many years of experience in the Medical Device industry, with expertise that comes not only from setting up compliant regulatory and quality systems but also from practical business experience. For more information regarding Reglera visit www.reglera.com or contact John Dupont at 800.341.4255 or [email protected].

About Hogan Lovells
Hogan Lovells FDA Medical Device practice is grounded in an in-depth understanding of the industry and its relationship with the U.S. federal government. Our clients range in size from small start-ups to established Fortune 500 companies, foreign manufacturers, and trade associations. Whatever our clients' size, we listen carefully and leverage our years of experience to assist them in meeting their objectives. Our experienced medical device lawyers - most with scientific or medical backgrounds - are bolstered by regulatory specialists who help us to provide cost-effective scientific and regulatory affairs advice. We help clients mitigate risks and pursue opportunities through timely, effective counsel on matters relating to the entire medical device life cycle. From inception and approval to debut and product maturity, clients benefit from guidance that reflects their business strategies and legal needs. www.hoganlovells.com

About CPC Clinical Research
CPC Clinical Research is an academically led clinical research organization that has responded to the demands of a fast-paced clinical research industry and competitive market for over two decades. CPC offers full service clinical trial design, oversight, and management with expertise controlling variability in data collection. CPC is known for its collaborative approach with sponsors, sites, and vendors providing superior communication and seamless clinical trial management. www.cpcmed.org