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NewswireToday - /newswire/ -
Lakewood, CO, United States, 04/20/2011 - Reglera, LLC’s upcoming Reproductive Regulatory Compliance Conference 2011 Atlanta will feature educational seminar sessions that detail the FDA regulations reproductive tissue establishments are required to follow and for achieving FDA compliance.
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Reglera, LLC recently announced its 5th Reproductive Regulatory Compliance Conference to be held September 22-23, 2011 at the Hilton Atlanta Hotel in Atlanta, GA. This September’s Reproductive Compliance Conference will feature presenters with expert experience in this regulatory field, including Reglera President and CEO Clay Anselmo; Martha Wells, VP of Regulatory Affairs for Tissue and Biologics; Senior Quality Assurance Director Rich Weiskopf; and Russell Bierbaum, President of ReproTech, Ltd., a worldwide leader in long-term storage of reproductive tissues. Seminar sessions will outline the specific regulatory requirements reproductive tissue establishments are required to follow and best practices to help establishments achieve compliance. This conference will also provide dedicated time for interactive discussion of many real case examples of recent compliance problems. Specific presentation topics covered include (but are not limited to) the following: Who are your Regulators and Regulatory History, How to Manage your FDA Inspection, FDA Inspectional and Enforcement Update, Donor Eligibility and Management, Donor Records Problems and Solutions, Elements of Document Control, Manufacturing Arrangements, Embryo Donation, Tissue Labeling, Storage and Quarantine, and Requests for Exemptions.
The FDA 21 CFR Part 1271 requirements for reproductive tissues have been in effect now for over six years. However, for the second year in a row, FDA noted in recent information presented on tissue inspections that reproductive establishments still had the highest percentage of inspections rated with an Official Action Indicated (OIA), meaning that objectionable conditions were found that warrant action. Reglera’s Reproductive Compliance Conference 2011 Atlanta will offer reproductive tissue establishments the tools they need to develop a strategy for maintaining FDA regulatory compliance. From information on donor testing and screening to document control, this educational event will cover all elements necessary for developing a compliant quality system for reproductive tissue establishments. To secure your attendance at the Reproductive Compliance Conference 2011 Atlanta visit reglera.com today and click on the graphic to register or call 800.341.4255 and ask for Jo Palumbo. Space at the event will be limited and reservations will be made on a first-come first-served basis, so do not delay in securing your place at this highly valuable and informational event.
About Reglera
Based in Lakewood, CO, Reglera (reglera.com) 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 Tissue industry, with expertise that comes not only from setting up compliant regulatory and quality systems but also from practical business experience.
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info[.]reglera.com 
