Guest Bloggers
Michael Causey, Editor and Publisher
eDataIntegrity Report
Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past ten-plus years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers.
His two biggest remaining goals in life are to find out when 21 CFR Part 11 will be revised, and to play drums in a rock band.
James Holler, Founder
Abidance Consulting
As founder of Abidance Consulting, James Holler became involved with the NERC Reliability & CIP Standards in 2006 and has since worked on more than 70 NERC related audits in each of the 8 regions. He has developed multiple training programs for companies such as Exxon/Mobil; City of Riverside, CA; National Grid; Waste-Management; PG&E; Hydro-Quebec and others. He’s also developed multiple programs associated with both the NERC Reliability Standards and CIP Standards.
Ken Miles, Principal
Alpha Quality Assurance
Ken Miles has 28 years experience as a senior FDA medical device investigator. Today, as an FDA consultant, he helps medical device companies navigate the regulatory passageways to maintain processes certification and guide them to device approval.
He assists the medical device industry in complying with FDA requirements. His expertise includes evaluating Good Manufacture Practice (GMP) and Good Laboratory Practice (GLP) compliance, Quality System Regulations, and QSIT certification inspections (Management, Design, Process Controls, and CAPA).
His clients range from small start-up companies to global corporations with domestic and foreign manufacturing sites that produce a variety of medical device products including x-ray imaging and therapeutic systems, surgical instruments, catheters, in-vitro diagnostic (IVD) products.
Mark Mansour, PartnerBryan Cave, LLP
Mark Mansour is head of the FDA practice at Bryan Cave LLP. He has practiced US and international drug and device law since 1991. Mark’s practice focuses upon domestic and international drug, device, food and consumer product regulation, as well as regulatory and public policy issues relating to the device, drug, biotechnology and nanotechnology industries.
He also assists clients in developing and implementing strategies for multinational, medium sized as well as start-up companies facing challenges with international regulatory policy and compliance requirements. He received his B.S. in International Politics from the Georgetown University School of Foreign Service, his M.A. in International Affairs and Public Policy from Harvard University, and his J.D. from Georgetown University.
