Workshops and Seminars
2010 Events
WORKSHOP ANNOUNCEMENT
QSR OVERVIEW With Comparison to ISO 9001/13485
September 13, 2010
In response to local biomedical industry needs the Biomedical Consortium presents well-known speaker and consultant, Russ Ziebell, who will conduct a one-day workshop on FDA’s Quality System Regulation (QSR) with comparisons to ISO 9001 and ISO 13485 requirements.
- When
- September 13, 2010
- 8:15 am to 5:00 pm, (Registration at 7:45 am)
- Where
- Century College
- 3300 Century Avenue N.
- White Bear Lake, MN 55110
- 651-779-3200
- Presenter
- Russ Ziebell, River Systems
Cost
- $199 ASQ member
- $249 nonmember
- $179 (3 or more from one company)
- Includes all materials, breakfast, breaks and lunch
Registration
To register click here »
Register early – space is limited.
About the workshop
This workshop for management and auditors provides a detailed overview of FDA’s QSR with comparisons to ISO 9001 and ISO 13485. Participants will gain basic understanding of the QSR from a business operations model and an audit application standpoint. They also will learn how QSR can be mapped to ISO 9001/ISO 13485 with the intention of merging the systems. Recertification units = 0.8 RU’s.
About the instructor
Russ Ziebell has been consulting in conformance management systems for quality, environment, health and safety since 1992. Mr. Ziebell established River Systems in 1996. Russ has authored and delivered ISO based courses including the internationally recognized ISO 9001 (ISO 13485) (Quality) Certified Lead Auditor, ISO 14000 (Environment) Certified Lead Auditor and OHSAS 18001 (Health & Safety) Lead Auditor Training programs, certified through RABQSA International. Russ has successfully worked with organizations to certification and conformance to the different ISO Quality standards (ISO 9001, ISO 13485, AS9100, TS16949, TL9000), Environment and Safety management standards and CFR 820 QSR (QSIT) for medical. He has consulted and trained organizations in the integration of ISO 9000, ISO 14000 and OHSAS 18001 management systems. Russ is a RABQSA Certified Lead Auditor (#01807). Audited for KEMA Quality Registrars, Inc. Quality, Environment and Health & Safety Management Systems and presently auditing for IAPMO R&T Registrars. Russ is a Skills Examiner for RABQSA. The Skills Examiner witnesses and evaluates applicants for becoming a Certified Lead Auditor under the RABQSA competency auditor scheme TPECS.
Mr. Ziebell was an original partner at Applied Quality Systems, Inc. management consulting firm and QAI Inc., where he designed and delivered the internationally recognized Certified Lead Auditor Training programs, accredited and certified through RABQSA International. Russ has worked in a variety of industries in multiple engineering/management positions for Pope & Talbot Paper, Texas Instruments and Cray Research. Russ was also a General Manager, reporting directly to the owner of a midsize plastic injection molding company, where he implemented personnel policies, management structure and an environmental-safety management system. Mr. Ziebell was an examiner for the Malcolm-Baldrige style Wisconsin Forward Award in 1998. Russ has been an adjunct professor at the University of Wisconsin-Stout and Hennepin Technical College.
Biomedical Consortium – a Task Group of Minnesota Section 1203, ASQ
PAST 2009-2010 Events
QSR OVERVIEW With Comparison to ISO 9001/13485
September 14, 2009
In response to local biomedical industry needs the Biomedical Consortium presents well-known speaker and consultant, Russ Ziebell, conducted a one-day workshop on FDA’s Quality System Regulation (QSR) with comparisons to ISO 9001 and ISO 13485 requirements. This is the fourth of these popular workshops presented in the last three years. Attendance was limited to about 12 due to email advertising problems.
About the workshop
This workshop for management and auditors provided a detailed overview of FDA’s QSR with comparisons to ISO 9001 and ISO 13485. Participants gained basic understanding of the QSR from a business operations model and an audit application standpoint. They also learned how QSR can be mapped to ISO 9001/ISO 13485 with the intention of merging the systems.
About the instructor
Russ Ziebell has been a management consultant in compliance management systems for quality, environment, health and safety since 1992. Mr. Ziebell started River Systems in 1997 and with his partner formed in 1999 an internationally recognized training company called QAI that specializes in ISO 9001, QS/TS16949, AS9000/9100, ISO 13485, Six Sigma, Environment ISO 14001 and Health & Safety OHSAS 18001 Management System training. Russ has authored and delivered the internationally recognized ISO 9000/ISO 13485 Certified Lead Auditor Training program, accredited through the U.S. National Registration Accreditation Board (RABQSA) for QAI. Russ is also a RABQSA Certified Lead Auditor and has worked for KEMA Quality Registrars Inc. and is presently a RABQSA Skills Examiner. He has been an adjunct professor at the University of Wisconsin-Stout and Hennepin Technical College.
FDA Hot Topics: A Forum with Complimentary Breakfast
October 28, 2009
A forum covering current “Hot Topics” related to FDA inspections and compliance was presented by the Biomedical Consortium, October 28th. Tim Philips, a Compliance Officer from FDA’s Minneapolis District, led the forum. He did a short presentation covering current developments in FDA followed by scenarios involving FDA regulatory compliance issues. Approximately 60 participants generated considerable discussion and debate.
About the forum
The FDA “Hot Topics” Forum has been a popular subject in past biomedical conferences. It showcases new developments and trends on the FDA regulatory scene in an effort to educate regulatory professionals and promote industry compliance with an ultimate goal of increasing the safety and efficacy of medical devices.
About the forum leader
Tim Philips is a Compliance Officer with the Food & Drug Administration where he coordinates legal and administrative actions against violators of the Food, Drug and Cosmetic Act. Tim has a Bachelor's Degree in Biomedical Engineering from the University of Iowa. He joined FDA's Minneapolis District Office in 1988. Prior to becoming a Compliance Officer, he worked for 12 years as a field investigator specializing in medical devices. Tim is a level II certified medical device investigator and a performance auditor in FDA’s medical device certification program. He is a frequent speaker at industry and FDA-sponsored medical device programs.
MDD 2010 – NOW WHAT? Doing business in Europe? Guess what? Things are changing!
December 2, 2009
The Biomedical Consortium sponsored a half-day seminar on the proposed changes to the European Union’s Medical Device Directives (MDD) to help medical device companies understand them. These changes are effective in 2010 and will affect these companies as they strive to sell medical devices in Europe. Participants had the opportunity to ask many questions. About 20 persons attended. The presenter was Jeff Witte from Notified Body, BSI.
CAPA Workshop
February 23, 2010
The Biomedical Consortium again offered its highly successful and well-attended one-day CAPA workshop on Tuesday, February 23, 2010. Tim Philips, Compliance Officer with the FDA, Minneapolis District and Sue Jacobs, Founder and Principal Consultant, QMS Consulting, both well-regarded experts on this subject, repeated as featured presenters. The workshop was again well attended with about 60 participants.
Variation is a fact of life in human interaction, materials and nature. When this variation has the potential of affecting human use of products or services, effective management requires continuing corrective and preventive action to assure product safety and effectiveness. Participants learned the regulatory foundation for CAPA as well as how to design and apply analytical tools and techniques for maximum CAPA system benefit. Mr. Philips presented FDA interest and experience with medical industry commitment to and compliance issues with CAPA. He had open discussion and class exercises focused on appropriate management response to CAPA regulatory requirements. Ms. Jacobs detailed topics supporting proper design of a responsive CAPA system. Also through presentation, open discussion and case study exercises she prepared the attendee with practical techniques for implementing a compliant program. Included topics were Corrective Action vs. Preventive Action, use of design control to drive CAPA, prioritizing and risk application, the CAPA process design, and use of multiple data sources for Management Review.