LAKEWOOD, CO, February 17, 2010
/24-7PressRelease/ -- Reglera, LLC recently announced the return of its popular Reproductive Regulatory Compliance Conference series with an upcoming event to be held June 2-3 2010 in the Millennium Knickerbocker Hotel in Chicago, IL. This June's Reproductive Compliance Conference will feature as a speaker former FDA Branch Chief of the Human Tissues and Reproductive Branch Martha Wells. Wells recently joined Reglera as the Vice President of Regulatory Affairs for Tissue and Biologics after retiring from a 36 year tenure with the FDA. She will bring a unique perspective and unparalleled depth of knowledge on FDA-related issues to Reglera's 2010 conference agenda.
As a part of her experience with the FDA, Wells was responsible for the coordination, development and implementation of the FDA's new regulatory paradigm for human cells and tissues, including those regulated as biological products and medical devices. She was also responsible for the management of FDA regulatory review of premarket submissions for human cells, tissues, and cellular and tissue-based products related medical devices and infectious disease donor screening test kits. Wells has been a frequent and distinguished FDA expert speaker at US and international meetings with industry, professional associations, and consumers as a leading FDA expert on the regulation of reproductive cells and tissues. She has also been an appointed member of numerous FDA special committees and task forces.
Martha Wells is slated to be joined at Reglera's upcoming Reproductive Compliance Conference Chicago by other presenters including Reglera President and CEO Clay Anselmo, Director of Quality Rich Weiskopf, and Quality Specialist and former FDA Investigator Steve Yost. All presenters will facilitate educational seminar sessions that will outline the specific regulatory requirements reproductive tissue establishments are required to follow and best practices to help establishments achieve compliance. Specific presentation topics covered include (but are not limited to) the following: How to Manage your FDA Inspection, FDA Inspectional Update, Guidance on Donor Eligibility for Donors of HCT/Ps, Donor Records Review, Document Control and Training Requirements, The Intricacies of Embryo Donation, Tissue Labeling and Storage, and Requests for Exemption or Alternative.
Reglera's Reproductive Compliance Conference Chicago will ultimately offer reproductive tissue establishments the tools they need to develop a strategy for maintaining FDA regulatory compliance. From information on Donor eligibility screening to document control, this educational event will cover all elements necessary for developing a compliant quality system in reproductive tissue establishments. To secure your attendance at the Reproductive Compliance Conference Chicago visit http://www.reglera.com today and click on the graphic to register or call 800.341.4255 and ask for Rachele McCawley. Space at the event will be limited and reservations will be made on a first-come first-serve basis, so do not delay in securing your place at this highly valuable and informational event.
About Reglera, LLC
Reglera provides regulatory and quality assurance consulting and outsourcing services to both the medical device and human cellular tissue industries. Reglera's unique combination of regulatory expertise and operations knowledge helps deliver results that combine regulatory compliance and process efficiency. Reglera has many years of experience in the Tissue industry, with expertise that comes not only from setting up compliant regulatory and quality systems but also from practical business experience.
For additional information about Reglera, contact Tim Anschutz at anschutzt@reglera.com or call 800.341.4255.
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