ROCKY MOUNTAIN BIOMEDICAL DISCUSSION GROUPROCKY MOUNTAIN BIOMEDICAL DISCUSSION GROUPIN CONJUNCTION WITH IN CONJUNCTION WITH

ROCKY MOUNTAIN REGULATORY AFFAIRS PROFESSIONALS SOCIETYROCKY MOUNTAIN REGULATORY AFFAIRS PROFESSIONALS SOCIETYpresents

2002 Winter Meeting

Thursday, December 12, 2002Sheraton FourPoints Cherry Creek (Denver)

Registration 8:30 amProgram 9:00 am to 4:00 pm

GUEST SPEAKER INTRODUCTORY COMMENTS from Ms. B. Belinda Collins, FDA Denver District Director

Team Presentations “Regulatory Aspects and Applied Interpretation” HACCP - Nanci Dexter & Neil Burris

PROCESS VALIDATION - Andy Snow & Adrian ElfeDESIGN VERIFICATION/VALIDATION - Kevin Walls & John Chappell

COMPLAINTS - Bob Moore & Julie Chaffee

Cost per person: $99Space 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

MAIL-IN REGISTRATION FORM

RMBDG-RAPS MEETING, WINTER 2002Thursday, 12 December 2002 - 8:30am to 4:00pm

Name(s):_________________________________________________________________________

_________________________________________________________________________

Title(s): _________________________________________________________________________

_________________________________________________________________________

Address: ________________________________________________________________________

City: ________________________ State:____________ Postal Code: ________

Phone: ___________________________ FAX: _____________

e-mail: _________________________________________________________________________

Number Attending _________ @ $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: 303 757 3341

A room rate of $89 is being held for this event. Please contact the hotel directly prior to 29 November 2002.

About the Speakers for the RMBDG Meeting - Winter 2002

Neil BurrisNeil 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 Group’s 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 ChaffeeJulie 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 ChappellJohn 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 DexterNanci 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 ElfeAdrian 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 SnowAndrew 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 MEDtech’s 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 WallsKevin 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 R&D 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.