Pre-Conference Workshops
FDA/Xavier University Medical Device Conference, May 4-10, 2010
Primer - Clinical / Regulatory Affairs |
8:30 - 4:00 p.m. | $450 | Details |
Pimer - Quality Assurance |
8:30 - 12:00 p.m. | $250 | Details |
Supplier Quality Controls |
12:00 - 4:00 p.m. | $250 | Details |
Pre-Conference Workshop Descriptions
Primer – Clinical / Regulatory Affairs
This Primer course is designed to prepare industry professionals for the content that will be addressed during the MedCon Medical Device Conference on the following 2.5 days. The trainers will team teach the topics, engage the participants, evaluate case studies, and review pertinent industry challenges and initiatives related to Clinical Trials and Regulatory Affairs. A more detailed course outline will be posted when available.
Time: 8:30am – 12:00pm
Course Fee: $250
Register Now.
This is a must attend event! Training is provided by a current FDA official and an Industry Expert at the lowest registration fee possible. We don’t want you to miss this rare opportunity!
Trainers:
- Laureen Geniusz, Investigator, Medical Device Specialist, FDA, Cincinnati District
- Barbara Immel, President, Immel Resources LLC.
Meet the Trainers:
Laureen Geniusz
Investigator, Medical Device Specialist
FDA, Cincinnati District, Brunswick Resident Post
Laureen has been with the Food & Drug Administration since 1990. Her office is located in a suburb of Cleveland, OH. In this role, she handles routine & complex medical device inspections/investigations, conducts training, and works closely with other Agencies. She is also a Performance Auditor and Cincinnati District's Registration & PMA Monitor. She graduated with a degree in Biology/Chemistry from Bowling Green State University.
Barbara Fant, Pharm.D.
Principal Regulatory Consultant and President
Clinical Research Consultants, Inc.
Phone: (513) 961-8200
BSFant@CRC-Regulatory.com
Barbara has 25 years of experience in pharmaceutical and medical device research and development. CRC has successfully filed over one hundred IDE’s, pre-IDE’s, 510(k)’s, and PMA’s with the FDA to bring investigational products to the marketplace. Dr. Fant served chair of the ANSI Z80.11 committee for 3 years and chair of its clinical subcommittee for 5 years; recently co-chaired the Drug Information Association’s (DIA) Medical Device Symposium; is a past chairperson of the DIA’s Medical Device Special Interest Group Program Committee; coordinates the medical device lecture series for the University of Cincinnati’s Master’s Program; serves on the Board of Directors for Medennium, Inc; is the founder of the VEO Research Consortium; and is the founder of the Integrated Center for Device Development. She holds a B.S. in Pharmacy from Ohio Northern University and a Doctor of Pharmacy degree from the University of Cincinnati.
Primer – Quality Assurance
This Primer course is designed to prepare industry professionals for the content that will be addressed during the MedCon Medical Device Conference on the following 2.5 days. The trainers will team teach the topics, engage the participants, evaluate case studies, and review pertinent industry challenges and initiatives related to Quality Assurance. A more detailed course outline will be posted when available.
Time: 8:30am – 12:00pm
Course Fee: $250
Register Now.
This is a must attend event! Training is provided by a current FDA official and an Industry Expert at the lowest registration fee possible. We don’t want you to miss this rare opportunity!
Trainers:
- Cincinnati FDA District Device Specialist (TBA)
- Barbara Immel, President, Immel Resources LLC.
Meet the Trainers:
Cincinnati District
Device Specialist
TBA
The Cincinnati District of the Food & Drug Administration is offering to allow one of their Medical Device Specialists to team-teach this course. Information regarding this Device Specialist will be listed as soon as it becomes available.
Barbara Immel
President
Immel Resources LLC
Phone: (707) 235-3387
immel@immel.com
Barbara has worked with pharmaceutical, biotechnology, and medical device companies in more than 20 countries, and has been teaching compliance classes for more than 20 years. Before starting her company in 1996, Barbara gained more than 12 years of hands-on experience in quality assurance and regulatory compliance at Syva Company, Chiron Corporation, and Syntex Corporation. Barbara served as the regulatory compliance columnist for BioPharm magazine for more than 10 years. She is editor of the Immel Report™ newsletter, which provides advice and guidance for managers in FDA-regulated industry. She has published more than 50 articles in Medical Device & Diagnostic Industry, Pharmaceutical Technology, Pharmaceutical Technology Europe, BioProcess International, Nutraceutical Business and Technology, and BioPharm. Barbara serves as chairperson of the annual FDA Inspections Summit hosted by FDAnews, and is a graduate of the University of California, Santa Barbara.
Supplier Quality Controls
Medical device manufacturers are becoming increasingly dependent on outsourcing raw materials, parts, subassemblies and even the manufacture of finished devices. These suppliers may be situated locally, across the country or in low cost, developing countries halfway around the world. Regardless of the supplier’s location, it is essential that the manufacturer establish efficient and rigorous supplier control programs to assure the quality of the materials and products they are outsourcing for use in their finished devices. There continue to be a number of high profile press reports of recalls, deaths and injuries associated with FDA-regulated products which can be attributed to supplier control problems. These situations have refocused the attention of Congress, FDA and the American public on the importance of ensuring that appropriate purchasing controls are in place to assure quality of outsourced products, processes and services.
Attendees will:
- Learn the essential elements of a successful supplier quality program
- Learn about the requirements of the recently published GHTF document on Supplier Quality
- Evaluate a case study on supplier quality
- Assist in developing a risk-based supplier quality program based on the case study
- Determine different ways to assess suppliers based upon risk
- Learn the importance of developing solid contractual agreements and change control procedures
- Understand the importance of supplier quality and its relevance to FDA’s quality system requirements
Time: 12:00 – 4:00pm
Course Fee: $250
Register Now.
Trainer:
- Steven M. Niedelman, Senior Consultant, Crowell and Moring, LLP
Former FDA Deputy Associate Commissioner for Regulatory Operations and COO
Meet the Trainer:
Steven M. Niedelman
Senior Consultant
Crowell & Moring LLP
Phone: (202) 508-8786
sniedelman@crowell.com
Steven Niedelman is a Senior Consultant to the Health Care Group at Crowell & Moring LLP, specializing in regulatory, enforcement and policy matters involving industries regulated by the Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and foods industries to assure conformance to the requirements of the Federal Food, Drug and Cosmetic Act. Based on his knowledge of FDA requirements, policies and procedures, Mr. Niedelman provides insight, guidance and training in FDA requirements to manufacturers, importers, new product developers as well as those firms involved in or facing enforcement actions. Mr. Niedelman helps firms develop corrective action plans that assure their business needs as well as regulatory requirements are properly balanced to assure compliance is achieved without compromising business objectives. He provides training and coaching to industry in all FDA requirements including quality systems requirements, inspection preparedness, postmarket obligations, and to executive management about FDA’s expectations and their management responsibilities. Until July, 2008, Mr. Niedelman served as Executive Vice President of Quintiles Consulting, a global consulting firm specializing in providing strategic advice, insight and guidance to the Medical Device, Pharmaceutical and Biologics industries.
Mr. Niedelman retired from the U.S. Food and Drug Administration in 2006 after a 34 year distinguished career where he served as Deputy Associate Commissioner for Regulatory Operations and Chief Operating Officer. He provided direct oversight over the headquarters offices of the Office of Regulatory Affairs (ORA), and assured consistent interpretation of FDA’s regulatory policies by directly overseeing the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations, and assisted in the day-to-day management of FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. He served as ORA’s principal liaison to the Center for Devices and Radiological Health where he was a member of the FDA/Device Industry Grassroots Initiative Steering Committee, the Global Harmonization Task Force (GHTF) Steering Committee, and the CDRH Postmarket Initiative Steering Committee. He represented FDA as a negotiator in the creation and reauthorization of the Medical Devices User Fee Act (MDUFA). He served on the Steering Committee to the pharmaceutical “cGMP for the 21st Century” initiative, as well as the Counterfeit Drug Task Force. Prior to joining the Office of the Associate Commissioner, he served as the Director, and Deputy Director of FDA’s Office of Enforcement, assuring oversight and consistency over compliance policy, enforcement and recall activities to assure they were fairly implemented by FDA’s five product Centers. Mr. Niedelman presided as the Chairman of FDA’s Compliance Policy Council. He currently participates as a member of the Medical Device Committee at the Food and Drug Law Institute, and as a member of the Editorial Review Board for FDA News GMP publications directed at the pharmaceutical and medical device industries.
Before joining the Office of Enforcement in 2001, Mr. Niedelman spent nearly 24 years throughout the Office of Compliance at the Center for Devices and Radiological Health (CDRH) in several management positions. During those nearly 24 years at CDRH, he was responsible for implementing many of the newly created statutory requirements and drafting and shaping many of the regulations and policies affecting the sale, distribution and promotion of medical devices. He began his FDA career in 1972 as an Investigator in FDA’s New York District Office.
Mr. Niedelman received his BA in Biology and Chemistry from the College of Emporia, Emporia, Kansas in 1971.
