Master the Design Controls Process with Automation & Planning
21 CFR Part 820 stipulates that “each manufacturer of a Class II or Class III device
shall establish and maintain the procedures to control the design of the device
in order to ensure that specified design requirements are met.“ Compliance with
this regulatory mandate is often viewed to be a daunting task. However, with the
proper approach and the effective use of technology, organizations can not only
easily achieve compliance, but all realize tremendous operational benefits.
Join us as we talk with Cynthia Pritchard and Billy Usrey of BioTechnology Transfer
about how a best-practice design control strategy can truly accelerate the commercialization
process. We will review design control basics and importance, discuss the risks
of not leveraging design controls, walk through potential pitfalls and challenges,
and detail best practices for the use of design controls.
EVENT DETAILS
Date: Thursday, April 2, 2009
Time: 10:00 AM PST / 1:00 PM EST
Presented by: InfoStrength
Speakers: Cynthia G. Pritchard, PhD - President & CEO, BioTechnology Transfer, LLC
Billy C. Usrey, DMin - COO, BioTechnology Transfer, LLC
Russ King - Vice President, InfoStrength
About the Panel:
Dr. Pritchard has over 27 years in the medical industry, and has helped bring
more than 30 products from research into development through clinical trials and
manufacturing to market launch. She served in positions of increasing responsibility
at Syva (Roche), Serono, Becton Dickinson, Gene-Trak Systems (Abbott), Pharmanetics
and StemCo Biomedical, integrating various assay chemistries with instrumentation
and developing cell-based therapies. She has a strong regulatory and quality assurance
background, with extensive experience in GTP/GCP/GMP, ICH and ISO requirements,
clinical project management, design control, and documentation, and has written
over 30 successful submissions (510(k), IDE, DMF, IND) to CDRH and CBER divisions
of FDA. Dr. Pritchard obtained a BS in microbiology at the University of South Florida,
a PhD in virology at Virginia Tech, and postdoctoral training in molecular biology
in the Department of Biological Chemistry at Harvard Medical School.
Dr. Usrey brings experience in management systems design and implementation
from 25 years in industrial and medical device manufacturing and university settings.
He began his career as an industrial engineer before becoming a management and systems
consultant, later setting up and managing manufacturing systems in various industries
from electronics to medical devices. He has broad practical knowledge of project
management, in working to FDA-mandated design control and documentation, as well
as group communications and facilitation. Dr. Usrey obtained a BS in industrial
management at the University of Tennessee, Knoxville, a MDiv from Duke University,
and a DMin from Columbia Theological Seminary in Atlanta. His doctorate concentrated
on group formation and communication and the development of learning organizations.