Note: Because of the interactive style, all Workshops are limited to a maximum of 25 participants.
- SUN-101: Lean Simulation
- SUN-102: ISO 13485 Medical Device Standard
- SUN-103: Cost Effective Quality Management Standards
- SUN-104: Just Released 21st Century Drug/Device cGMPs
- SUN-105: Using QMS to Strengthen Your Business
-
TUE-201: Value Stream Mapping: Your First Step on the Lean journey
- TUE-202: Balanced Scorecard with Hoshin Planning
- TUE-203: Administrative Lean: Creating Value & Eliminating Waste in Non-Manufacturing Processes
- TUE-204: TS 16949: The Process Approach and the use of the Turtle Diagram
| Pre-conference Workshops |
Sunday, November 7, 2004 |
SUN-101: Lean
Simulation
Sunday, November 7, 2004, 8:00 a.m. – 5:00 p.m. CST $295
Facilitators: Tony Manos, Phil Catrintza and George Alukal, AMIG, Chicago, Illinois
About the Workshop
The participants manufacture electronic assemblies in a simulated factory and measure results such as on-time delivery, quality and profit margins. It is a unique experience in which they will be able to see, feel and analyze the effects of implementing different Lean manufacturing principles as each is incorporated into the simulation process, in four rounds. By learning and applying concepts presented at this simulation, you will have the basic tools to start implementing Lean to reduce cycle time and costs and to increase profits and customer satisfaction in your enterprise.
WORD file of workshop Brochure
SUN-102:
ISO 13485 Medical Device Standard
Sunday, November 7, 2004, 8:00 a.m. – 12:00 noon CST $150
Facilitator: Mohsen Arghavani, Ph.D., Baxter Healthcare, Round Lake, Illinois
About the Workshop
For medical device companies that are actively working in the global market place, the focus on harmonized and/or international standards is not only beneficial, but is required by many countries. An example would be Canada, which requires that medical device manufacturers marketing any product in Canada must have a quality system certified to ISO 13485 or ISO 13488. In the case of Europe, the harmonized medical device quality system standards are ISO 13485 and ISO 13488. These two standards have replaced harmonized standards EN 46001 and EN 46002. As for the U.S., the revised Quality System Regulation (21 CFR 820) was based on the ISO 9001 and ISO 13485 quality system standards. This workshop will focus on an in-depth introduction to ISO 13485 and comparison of it to EN 46001, EN 46002, and FDA regulations 21 CFR 820.
WORD File of Workshop Brochure
SUN-103: Cost Effective Quality
Management Standards
Sunday, November 7, 2004, 8:00 a.m. – 12:00 noon CST $150
Facilitator: Ken Jackman, Ken Jackman & Associates, Montello, Wisconsin
About the Workshop
Cost Effective Quality Management Standards means leveraging the ISO 9000 certification of your suppliers. Methods will be discussed to better use the quality data your company generates to ensure maximum participation of your suppliers. Learn how to detect if your suppliers are on the same page as your own company's quality objectives. These methods will utilize the data your company already generates and using that data for the reevaluation of suppliers as required by the ISO 9001:2000 Standard.
WORD File of Workshop Brochure
SUN-104: Just Released 21st Century
Drug/Device cGMPs
Sunday, November 7, 2004, 1:00 p.m. – 5:00 p.m. CST $150
Facilitators: James J. Capone, PhD, Diversified Biomedical Technologies, Inc., & Hugh G. Grimes, cGxP, Vernon Hills, Illinois
About the Workshop
The FDA plans to release its revised good manufacturing practices (GMPs) for pharmaceuticals in August 2004, states Acting Commissioner of Food and Drugs Lester Crawford. He said the new GMPs would be a "fundamental reform" of the regulations, which have not been revised in 25 years. "We look forward to inculcating those reforms into the culture of FDA." The workshop will focus on comparing these new 21st century cGMPs as they are being applied for drugs, devices, and biologics. Significant time will be given to show examples of the new tools which the FDA practitioner must have in their arsenal for the 21st century: Design of Experiments (DOE), Risk Assessment (RA), Statistical Process Control (SPC), Process Analytical Technologies (PAT), and the “critical path” initiative.
WORD File of Workshop Brochure
SUN-105: Using Quality Management System for Business Excellence
Sunday, November 7, 2004, 1:00 p.m. – 5:00 p.m. CST $150
Facilitator: Marlyn Hyde, Hyde Communications, Vernon Hills, Illinois
About the Workshop
Getting the most from your Quality Management System is the result of driving the standards from strategic planning on down through the organization. To get the most from the standards (ISO, TS, AS, TL, etc.), do what’s best for the business. The results will get best practices in writing, without adding unnecessary steps, using the Lean Enterprise model.
This interactive workshop will demonstrate effective Key Processes and Process Interactions identification, introduce the ISO Goal Setting process that links all key processes and measures to the strategic plans, and show how to apply Value Stream Mapping to the standards’ process approach. Developing and implementing this Cost Effective Quality Management System is the best thing you can do to strengthen your business.
WORD File of Workshop Brochure
| Post-conference Workshops |
Tuesday, November 9, 2004 |
TUE-201: Value Stream Mapping: Your
First Step on the Lean journey
Tuesday, November 9, 2004, 8:00 a.m. – 12:00 Noon CST $150
Facilitator: Tony Manos, AMIG, Chicago, Illinois
About the Workshop
The objective of Value Stream Mapping (VSM) is to generate a “door to door” Value Stream for a chosen product family, which can be used by company management to create a contemporary operations strategy in concert with the business growth and improvement objectives. The Value Stream Mapping is normally a cross-functional, team-based effort involving middle management facilitated by Quality or Operational leader/facilitator. It is intended as a first step in your Lean journey, for identifying and implementing improvements within the product family. VSM will walk the team through concepts of flow/Lean manufacturing, with an analysis of the current state of manufacturing based on the movement of materials and information. The team will then establish a future state Lean value stream in the chosen area and develop an implementation plan to achieve that future state in a comparatively short time using Kaizen.
WORD File of Workshop Brochure
TUE-202: Balanced Scorecard with
Hoshin Planning
Tuesday, November 9, 2004, 8:00 a.m. – 12:00 Noon CST $150
Facilitator: Manu K. Vora, Ph.D., M.B.A., Business Excellence, Inc., Naperville, Illinois
About the Workshop
In this workshop the critical importance of a Balanced Scorecard to sustain business performance excellence will be established. Basic concepts of developing business strategy, identifying critical measurements of non-financial (customer, employee, and process) and financial perspectives, and use of Hoshin Planning to implement the Balanced Scorecard process to achieve business strategy will be discussed. Specific emphasis on managing business strategy with focus on alignment, resource allocation, feedback, and strategic learning process for effective implementation of a Balanced Scorecard will be highlighted. Need to identify, analyze, and act on the right non-financial measures will be stressed. A case study on Balanced Scorecard and its implementation to translate strategy into action will be shared. At the conclusion of this interactive workshop, participants will be well equipped to embark on creating and managing Balanced Scorecard to achieve sustained organizational performance excellence.
WORD File of Workshop Brochure
TUE-203: Administrative Lean:
Creating Value & Eliminating Waste in Non-Manufacturing Processes
Tuesday, November 9, 2004, 1:00 p.m. – 5:00 p.m. CST $150
Facilitator: Walter O’Dowd, O’Dowd Engineering Resources, LLC, Flossmoor, Illinois
About the Workshop
Companies obtain improvements in administrative processes through the identification and elimination of wastes, such as waiting waste, inaccurate & incomplete information, excess reviews, “re-work”, etc. This workshop will train participants in a systematic approach in creating value in the eyes of the next customer. These methods are applicable for employees from the shop floor to the corporate boardroom.
WORD File of Workshop Brochure
TUE-204: TS 16949: The Turtle and the
Process Approach
Tuesday, November 9, 2004, 1:00 p.m. – 5:00 p.m. CST $150
Facilitator: Sheldon Behensky, Indak Manufacturing Corp., Northbrook, Illinois
About the Workshop
This half day workshop is designed for those who are involved with identifying, defining and documenting processes for ISO / TS 16949:2002 and ISO 9001:2000 compliance and registration.
During this interactive workshop you will gain insight into identifying the three different levels of processes, the Customer or Core process, the Support process and the Management process