American Society for Quality
Southern Connecticut Section 301
2005 - 2006
Chairman
Shams Alam
203-847-5137
Vice Chairman
Peter Shearer
203-258-2180
Secretary
John Rosen
203-452-7819
Treasurer
MikeD’Onofrio
203-570-3657
Committees:
Advisory & Publicity
Joseph Azary
203-944-9320
Arrangements:
Tony Pedro
Certification
Chuck Weiss
203-877-4558
Education
Mike D’Onofrio
203-922-3354
Employee Referral
John Menzer
203-356-5097
Examining
Sam Lagnese
203-255-0570
Historian
Gene Taylor
203-366-9137
Koalaty Kid
Bill Scerbo
203-261-4191
Membership
Narendra Patel
203-790-3595
NEQC
Andreas Lihv
203-354-4771
Newsletter
Trevor Craney
203-386-5317
trevor.craney@
sbcglobal.net
On-Line
Sol Silverstein
203-389-4241
Programs:
Maitrayee Ganguly
Scholarship
Cynthia Scheetz
203-931-0551
Upgrade Committee
Jack Kustan
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Meeting NoticeVisit us on the Web: “
Date:April 19, 2006Time:5:30 Social, 6:30 Dinner, 7:30 Seminar
Location: Casa Nova Restaurant, 833 River Road, Shelton, CT.
Phone: 203-929-9800Cost: $25.00
Directions: Merritt Parkway (15) North: Take Exit 53N and follow Route 110 North for about a mile to arrive at the restaurant. Merritt Parkway (15) South: Take Exit 53 and follow Route 110 North as above.
***** This meeting is the annual joint meeting with the New Haven Section 305 *****
______
Reservations are requested via email to Tony Pedro at “”.
Make your reservations by Tuesday, April 18th
Include your name, phone number, # attending.
We must pay for a minimum of 25 people. Please register today!
If you don’t cancel or don’t show we will still pay for your meal.
______
Speaker: Joseph Azary, Azary Technologies LLC
Topic:How to Integrate Risk Management as part of your Quality Management
System
Risk management can be used as a tool throughout a product lifecycle to reduce errors, liability and cost by prioritizing the most important risk concerns early.
Risk management is required by ISO 13485:2003, FDA regulations, and European Regulations.
The course will show participants how risk management can be used not only in the design of the product as well as other parts of the quality management system. Risk management should be an integral part of any lesson-learned portfolio.
The discussion will include the ISO 14971:2000 standard on risk management for medical devices
Chairman’s Message
Winter is over and spring is officially here in Southern Connecticut. This means we only have two more meetings for our section after this month. The year is almost over!
This month’s meeting is a joint meeting with our sister section of New Haven area. This is a yearly event with our neighboring section. We take turn to host this event. Last year New Haven section was host and did everything. This year it is our turn and Tony Pedro, our Arrangement Committee Chairman has found a good place for this joint meeting.
Joseph Azary is our speaker for this month. Most of you know that he is our past Section Chairman and currently serving as our Regional Deputy Director. He was very kind to agree to be our speaker for this meeting. As you all know, Joe is very busy with his successful consulting business but somehow he finds time to serve as our speaker when we need him. We are very fortunate to have him in our section.
We are still looking for two speakers for the last two months for this year. Please contact our Section Program Committee Chairperson Maitrayee Ganguli if you know anyone interested to present a seminar in our section or consider yourself for this opportunity. It is not as difficult as you think.
Please feel free to contact me at or call me at 800-888-4848 Ext. 1424 with your ideas or suggestions.
Shams Alam, Ph.D.
2005-2006 Program
Date & Location Speaker & Seminar Topic
______
April 19thJoseph Azary
Casa Nova, Shelton, CT
May 10thTBD
June 14thTBD
Section Announcements
The Nominations Committee is pleased to announce its list of candidates for the upcoming 2006-2007 as follows…
Chairman:Mike D’Onofrio
Vice Chairman:Trevor Craney
Treasurer:John Rosen
Secretary:Joseph Azary
Joseph Azary has more than 15 years in the healthcare/medical device industry experience in all phases of regulatory affairs and quality assurance.
Joseph holds a bachelor’s degree in Biological Sciences and a Master’s degree in Business Administration (MBA) healthcare concentration. Joseph is an ASQ Certified Quality Auditor (CQA), Regulatory Affairs Certified (RAC), and has passed the RAB Lead Assessor requirements.
As an undergraduate Joseph worked as an assistant in a hospital laboratory and as a Quality Control Chemist at the Richardson-Vicks division of Procter & Gamble. He has held regulatory and quality positions at U.S. Surgical Corporation, Johnson & Johnson, and Fuji Medical Systems (division of Fuji Photo Film Co).
Joseph formed Azary Technologies LLC in 1999. Azary Technologies provides regulatory and quality consulting services to organizations in the healthcare industry. He specializes in the medical device industry and has worked with a variety of devices including radiological, neurological, surgical instruments, bio-magnetic products, gynecological, cardiovascular, endoscopes, drug/device combination devices, sterile, implantables, orthopedic, x-ray film, digital imaging equipment, medical imaging software, and ultrasound. He provides services such as 510(k) submissions, auditing, training, quality system development, adverse event reporting, complaint handling, ISO 13485 / 9001 preparation, device listing, technical writing, mock FDA audits, recall coordination, and regulatory strategic planning.
Joseph is an active member of the American Society for Quality (ASQ) and the Regulatory Affairs Professional Society (RAPS). He has taught courses on auditing and quality systems for the NorthEast Quality Council (NEQC) and Housatonic Community College.
CERTIFICATION EXAM REFRESHER COURSES
SPRING INTO ACTION!
The following certification exams have an April 7, 2006 application deadline for a June 3, 2006 exam.
- Certified Quality Auditor (CQA)
- Certified Quality Improvement Associate (CQIA)
- Certified Quality Engineer (CQE)
- Certified Calibration Technician (CCT)
Courses for CQA or CQE are being arranged in the southeastern Fairfield county area.
Or attend the Fall classes for the December exam dates. The following certification exams have an August application deadline for an October exam.
- Manager of Quality / Organizational Excellence (CMQ)
- Certified Quality Technician (CQT)
- Certified Mechanical Inspector (CMI)
- Certified Reliability Engineer (CRE)
The prep courses run in the Spring, Fall, and Winter.
Sign-up soon. Please e-mail , or call Mike
D’Onofrio at 203-570-3657 for further information.
HEY COMPONENT MANUFACTURERS!THINKING ABOUT GETTING INTO THE MEDICAL DEVICE ARENA?
Your company may need ISO 13485:2003 registration. BSI Management Systems can help. BSI has over 42,000 registered clients in 90 countries, making us the largest and most experienced registrar.
BSI has developed a suite of products and services to help you achieve registration and get the most out of your management system.
- Free Guidance Documents
- ISO 13485:2003 Training and Registration
- Webinar: Overview of ISO 13485:2003
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Meeting NOTICE
Reserve TODAY!
April 19 at the Casa Nova Rest.
Shelton, CT
Advertise!Advertise!Advertise!
This section is reserved for your company logo advertisement. You can print your company’s logo or a two-line ad, 10 times a year for only $10 dollars per month. Other rates for inside pages: Half page $900, Quarter page $500, Business card size $300 for ten issues. You could also run an ad for any number of months or year. Contact: Tony Pedro () or Mike D’Onofrio (203-570-3657).