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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Mountain States Chapter Data Integrity Event

Apr 24 - Apr 24, 2018 |
Apr 24, 2018 |
Front Range Community College | Westminster, CO
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On Tuesday, April 24, 2018 join the PDA Mountain States Chapter for an exciting and timely conversation with noted experts Capt. Thomas Berry (FDA), and Sue Schniepp (Regulatory Compliance Associates, Inc.).

Join us at the Front Range Community College Westminster Campus room C0577, at 3645 West 112th Avenue, Westminster CO 80031.

Speakers

Sue Schneipp, Fellow at Regulatory Compliance Associates, Inc (speaking on behalf of PDA)
Susan Schniepp has 35 years experience in Quality Assurance. She is a Distinguished Fellow with Regulatory Compliance Associates Inc. advising clients on overall Quality and Compliance strategies. She was previously Vice President of Quality and Regulatory Affairs for Allergy Laboratories, Inc. and OsoBio Pharmaceuticals, LLC where she oversaw the activities of the Quality Assurance, Quality Control and Regulatory Affairs operations for the companies.  She has had responsibilities for laboratory analysis, method validation, complaints, labeling, investigations, compendial affairs, and other quality systems during her 35 years in the industry.  As an active member of PDA, Sue served on the Board of Directors from 2011-2014 and has been a member of the PDA/FDA Joint Regulatory Conference since 2001, chairing the conference in 2007 and co-chairing it from 2010 through 2014.  In addition to her involvement with PDA/FDA Joint Regulatory Affairs Conference, Sue is Chair of PDA’s Regulatory Affairs/Quality Advisory Board and has presented at many PDA venues.  In 2007 she was the recipient of PDA’s Distinguished Author Award for the book Understanding the United States Pharmacopeia and the National Formulary:  Demystifying the Standards-Setting Process, in 2008 she received PDA’s Distinguished Service Award and in 2009 she was presented the PDA Gordon R. Personeus Award.  Since 2007, Sue has served as a member of the editorial advisory board for Pharmaceutical Technology Magazine as well as authoring a quarterly column called “Insider Solutions”.  Sue was Chair of a USP Monograph Development Expert Committee from 2005-2010.  

Capt. Thomas Berry, PharmD, FDA Denver District Office
CAPT Berry graduated from Creighton University with a bachelor’s degree in pharmacy in 1992 and a doctor of pharmacy in 2009. He completed an American Society of Health-System Pharmacists accredited residency in Administrative Pharmacy Practice in 1996 at Fitzsimons Army Medical Center. He is currently an active duty Public Health Service Officer assigned as the Director of Compliance Branch for FDA Denver District. His past FDA experience includes four years as a Compliance Officer in Denver and seven years as an Investigator in Raleigh, NC. Previously, CAPT Berry held positions as a clinical pharmacist in Alaska and as a regional pharmacy consultant for the Indian Health Service. Prior to transferring his commission to the Public Health Service, he served as a U.S. Army Officer, hospital pharmacist and professional filler for deploying medical units. He was part of a medical task force to support the United Nations in Somalia, and his last Army assignment was Chief of Inpatient Pharmacy, Fort Carson, CO. 

Registration

FREE! Limited to 40 attendees, so register now!
There is no cost to attend this event but registration in advance is required as space is very limited.

Agenda

4:00-4:30 - Registration and networking
4:30-5:15 - Speaker 1 - Sue Schniepp
5:15-6:00 - Speaker 2 - Capt. Thomas Berry
6:00-6:30 - Q&A

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