ROCKY MOUNTAIN BIOMEDICAL DISCUSSION GROUP IN CONJUNCTION WITH ROCKY MOUNTAIN REGULATORY AFFAIRS PRO

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ROCKY MOUNTAIN BIOMEDICAL DISCUSSION GROUPIN
CONJUNCTION WITH ROCKY MOUNTAIN REGULATORY
AFFAIRS PROFESSIONALS SOCIETYpresents2002
Winter MeetingThursday, December 12,
2002Sheraton FourPoints Cherry Creek
(Denver)Registration 830 amProgram 900 am to
400 pmGUEST SPEAKER INTRODUCTORY COMMENTS
from Ms. B. Belinda Collins, FDA Denver District
Director Team Presentations Regulatory Aspects
and Applied Interpretation HACCP - Nanci Dexter
Neil BurrisPROCESS VALIDATION - Andy Snow
Adrian ElfeDESIGN VERIFICATION/VALIDATION -
Kevin Walls John Chappell COMPLAINTS - Bob
Moore Julie Chaffee

• Cost per person 99
• Space is limited register early
• Lunch and Breaks Provided
• To register contact KELLY BLAKELY at 720 293 9863
  or 1 800 492 6961
• Visa and Mastercard Accepted, or mail-in
  registration is available
• For more information, call Neil Burris or Michael
  Ryan at 1 800 633 0960
• YOU MAY USE THE REGISTRATION FORM FOUND ON THE
  NEXT PAGE

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MAIL-IN REGISTRATION FORMRMBDG-RAPS MEETING,
WINTER 2002Thursday, 12 December 2002 - 830am
to 400pm
Name(s)_________________________________________
________________________________
__________________________________________________
_______________________ Title(s)
__________________________________________________
_______________________
__________________________________________________
_______________________ Address
__________________________________________________
______________________ City
________________________ State____________
Postal Code ________ Phone ___________________
________ FAX _____________ e-mail
__________________________________________________
_______________________ Number Attending
_________ _at_ 99 each Amount Enclosed
________________________ Mail this form, with
check payable to RMBDG to Kelly Blakely c/o
ASQ Biomedical Division, PO Box 746497, Arvada,
CO 80006-6497 or call 1-800-492-6961
The Winter 2002 Meeting of the RMBDG-RAPS will be
held at Sheraton FourPoints - Cherry Creek,
600 South Colorado Blvd., Denver, Colorado 80246
phone [phone] A room rate of 89 is being
held for this event. Please contact the hotel
directly prior to 29 November 2002.
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About the Speakers for the RMBDG Meeting - Winter
2002
Neil Burris Neil Burris has worked in the
Medical Device Industry since 1987, and has
recently taken on responsibilities for Clinical
Data Management at the Spectranetics Corporation.
He is a Microbiologist by training, but has
worked in Quality Systems, Quality Auditing,
Process Validation, and Regulatory Affairs. With
respect to the Rocky Mountain Biomedical
Discussion Groups 2002 meeting agenda, he
believes HACCP (Hazard Analysis Critical Control
Point) to be a useful tool, which is neither
irrelevant nor contrary to the Quality System
Inspection Technique (QSIT). Julie
Chaffee Julie Chaffee has worked in the quality
field for nearly 20 years in one form or another.
Beginning with document control, and auditing
government records, moving through compliance and
regulatory submissions. She has previous work
experience at engineering firms, mortgage
companies, medical device manufacturers, and
currently works for a training and consulting
organization. As an IRCA Lead Auditor and ASQ
CQA, she teaches lead and internal auditor
courses on top of consulting with firms to
achieve compliance with regulations, standards,
and internal policies as well as the development
of quality management systems. Julie has just
finished her term as Chair of ASQ's Biomedical
Division, is still active on the committee,
participates on the board for a private high
school, and the local Boy Scout Troop. John
Chappell John Chappell is President of Cericon,
LLC, a company that provides professional
services to medical device and biomedical
companies, specializing in quality systems and
regulatory affairs. He has over twenty-five
years experience in leading and improving quality
systems and regulatory affairs primarily for
worldwide medical device companies. He has held
leadership positions in quality assurance,
regulatory affairs, manufacturing and engineering
in environments ranging from complex
electromechanical devices to precision high
volume single use devices. John has successfully
designed and implemented many quality/regulatory
systems including CAPA, design controls,
management systems and process controls. He has
a bachelor's degree in mathematics and a master's
degree in business administration. He is
Regulatory Affairs Certified (RAC) by RAPS, a
Certified Quality Auditor, Biomedical
(CQA-Biomedical) by ASQ and a Certified Quality
Engineer (CQE) by ASQ. Nanci Dexter Nanci Dexter
is owner and principal consultant for Compliance
Systems , LLC, a consultant and contract Quality
Assurance company which creates Quality
Management Systems for the Medical Device,
Pharmaceutical and In-vitro Diagnostic Device
industries. Her consulting activities include
holding various management and director level
positions in the areas of regulatory affairs and
quality assurance, auditing, and regulatory
submissions. Nanci has over 14 years experience
and is an American Society for Quality Certified
Quality Manager (CQM), Certified Quality Auditor
(CQA), and is Regulatory Affairs Professionals
Society certified (RAC). Adrian Elfe Adrian Elfe
is presently Vice President of Quality Assurance
and Regulatory Affairs for the Spectranetics
Corporation, a Medical Device manufacturer. He
is responsible for Quality Systems development,
implementation and regulatory compliance. Prior
to Spectranetics, he participated in Quality
System planning and implementation for nine
different spin-off/start-up businesses in three
different FDA Districts. Mr. Elfe has over 30
years experience in the Medical Device Industry.
Mr. Elfe has experience in Domestic and Foreign
Regulatory Compliance, microbiological QA, new
product development, product introduction and
manufacturing facilities integration and
relocation. Mr. Elfe has a technical background
in Electrical Engineering, Management Systems and
Manufacturing Technologies. He is a Certified
Quality Manager and a Regulatory Affairs
Certified Professional. Mr. Elfe also serves as
a Senior Consultant assisting organizations in
meeting their validation, auditing,
documentation, regulatory compliance, process
improvement, and quality system needs. He is
recognized by ASQ as an instructor for the
Certified Quality Manager Examination Refresher
Course. He is an elected Fellow Member of
ASQ. Robert C. Moore, Jr. Robert C. Moore, Jr.
RAC (US EU) is currently a senior regulatory
associate at Valleylab. Mr. Moore has over 20
years experience in Quality Assurance and
Regulatory Affairs in Medical Devices,
Pharmaceuticals and Biologics and is a former
Medical Device and Sterility Assurance Lead
Assessor with the British Standards Institution.
He has been a member of Rocky Mountain RAPS since
its inception and has held a RAC certification
since 1992. He attained RAC (EU) certification
in 2001. Mr. Moore has over a dozen publications
and has spoken on Quality System Regulations at
several conferences and professional meetings.
He has a BA in Psychology, BS in Laboratory
Technology and an MS in Microbiology from the
University of Oklahoma. Andrew Snow Andrew Snow
is a Quality Assurance professional with 20 years
of progressive quality engineering and management
experience. He currently is the Director of
QA/RA for Colorado MEDtechs Colorado Operations.
Prior to this he was a consultant helping
numerous companies including Alcon Laboratories
and Abbott Laboratories. He has extensive hands
on quality assurance, design and manufacturing
experience in Medical Devices. He has expertise
and proven results in Quality Systems
implementation, Process Validation, Design
Control, Concurrent Engineering methods and Risk
Analysis. He received his B.S. in Biology from
Fort Lewis College in Colorado and his M.E. in
Engineering from Northwestern University. He is
an ASQ certified Quality Engineer, and a trained
ISO 9000 Lead Assessor. He is an instructor in
Statistics and Quality and Productivity
Management at the University of Phoenix. Kevin
Walls Kevin Walls has been the Principal
Consultant for Regulatory Insight, Inc. in
Littleton Colorado since 1999. Prior to becoming
a consultant, Mr. Walls has held various
professional and management positions, including
regulatory affairs, quality assurance,
manufacturing, customer service and RD in four
Colorado medical device companies since 1988.
Mr. Walls is Regulatory Affairs Certified by the
Regulatory Affairs Professional Society and has a
BS degree in Electrical Engineering Technology
and MBA degree in Operations Management.