April Program Announcement
Quality Foundations
When/Where
- When
- Tuesday, April 13, 2010
- 5:00 PM to 9:00 PM
- Where
- North Metro Meeting & Event Center
- 1000 Gramsie Road
- Shoreview, MN 55126
- (651) 482-0402
Registration
Registration Deadline: April 9, 2010 at 12:00 Noon
There are 2 options to register for this event.
- Option #1: Register and pay Online. »
- Option #2: Call the section office at 651-779-9820 and leave a voicemail following the instructions. Please make sure that your member number is provided so you get charged member rates. Non-members are welcome!
**IMPORTANT** Note: Please register before deadline to avoid a late fee and guarantee a meal. Only personal checks or cash will be accepted at the time of registration. Hope to see you all at the event!
Cost
- $25 Members/ $35 Non-Members
- Late Registration/Walk-Ins: Add $5
- No Meal Option $0 - You may join us at no cost using the ‘no meal option’. You are welcome to bring your own meal.
Agenda
| Time | Event |
|---|---|
| 5:00 P.M. | Registration & Informal Networking |
| 5:45 P.M. | Welcome & Announcements |
| 6:00 P.M. | Pre-Dinner Presentation |
| 7:00 P.M. | Dinner |
| 7:45 P.M. | Post-Dinner Presentation |
| 8:45 P.M. | Closing Note & Speaker Gifts |
Pre-Dinner Presentation
Quality Measurement Hardware
If you haven’t had the opportunity to attend a Quality Show or any of the other trade shows and haven’t seen the latest in measurement devices, you won’t want to miss this presentation. It will give you an understanding of the latest in non-contact/optical and video inspection. Doug Emory will provide an overview of optical measurement as well as a brief history of non-contact/optical comparator use. He will discuss measurement capabilities and methods with optical comparators as well as video inspection systems use and application and practical applications for optical measurement.
Post-Dinner Presentation
Does Your CAPA need a CAPA?
Corrective and preventive action management is vital to an organization’s quality management initiatives. It ensures that issues that appear unexpectedly in the manufacturing process can be addressed quickly and efficiently, with procedures implemented to ensure these issues do not repeat themselves.
“A minute to learn, a lifetime to master.” Like all processes, CAPAs must be reviewed for efficiency and effectiveness. The CAPA subsystem is the most audited by FDA inspectors and routinely comes up wanting. In this presentation, Ken Brown will review and compare similar CAPA’s findings described by some of FDA Warning Letters and FDA 483s. He will describe in detail how Boston Scientific changed and improved their CAPA system to address and correct FDA CAPA findings against Boston Scientific. Ken will also provide useful insights on the essential features of a compliant CAPA system – as well as those that are nice to have. At the end he will also discuss efficiency concerns and cost considerations as one seeks an Optimal CAPA System versus a Substantially Complaint CAPA System.
About our Speakers
Ken Brown is the Director of Operations Quality at Boston Scientific’s Maple Grove Plant, managing 130 quality personnel supporting a 140,000 square foot manufacturing site that produces over 2 million medical devices per year. Ken has worked in Medical Device quality for 15 years in roles supporting product development quality, operations quality, supplier quality, and quality systems. He has been a member of ASQ since 1996 and is both CQE and a CRE. He has a Bachelor of Science from Iowa State in Industrial Engineering and a MS from University of Alaska Anchorage in Engineering Management. He has extensive experience handling external quality systems audits performed by FDA, EU Notified Bodies, and regulatory bodies from other countries (e.g. Japan, Australia, Brazil, etc.). Ken plays a very important role in managing company’s CAPA system ensuring effective closure to FDA satisfaction.
Doug Emory is S-T Industries’ Regional Sales Manager. S-T Industries, a Southwestern Minnesota Company, manufactures optical comparators and video inspection systems. They also carry a complete line of precision measuring tools, including micrometers, calipers, dial indicators & electronic tools. Doug has been in manufacturing since about 1980 and Sales soon after. A graduate of Stonehill College in North Easton Massachussetts, he was born in Pawtucket, Rhode Island and grew up in South Attleboro Mass. He currently resides in Rockford, Illinois with his wife Suzi. He has two children in their twenties and a spoiled rotten Puggle named Lucy.
Meeting Location Map and Directions
- North Metro Meeting & Event Center
- 1000 Gramsie Road
- Shoreview, MN 55126
- From the Northwest:
- Travel south on I-35W. Exit 27A to merge onto I-694 East. Take exit 43A for Lexington Avenue. Turn left on Lexington Avenue N. Turn right at Gramsie Road.
- From the Northeast:
- Travel south on I-35E. Take exit 43A for Lexington Avenue. Turn right on Lexington Avenue N. Turn right at Gramsie Road.
- From Southeast:
- Travel north on I-35E. Continue onto to US-10W. Take exit 43A for Lexington Avenue. Turn right on Lexington Avenue N. Turn right at Gramsie Road.
- From Southwest:
- Travel north on I-35W. Exit 27A to merge onto I-694 East. Take exit 43A for Lexington Avenue. Turn left on Lexington Avenue N. Turn right at Gramsie Road.
- From the East:
- Travel west on I-694. Exit 43A for Lexington Avenue. Turn right on Lexington Avenue N. Turn right at Gramsie Road.
- From the West:
- Travel east on I-694. Exit 43A for Lexington Avenue. Turn left on Lexington Avenue N. Turn right at Gramsie Road.