the variant - asq 1510 10 variant.pdf · kannan krishnan qe, qa, mq/oe, qia, ss , a 9 sessions...
TRANSCRIPT
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Greetings from your Southeast Florida Section 1510. Our Section held a well-attended joint meeting with Section 1515 of Greater Palm Beach on September 15
th at Tropical Acres Steakhouse in Fort Lauderdale.
For several years, January and March have been the two months of the year when we have had our meet-ings together with Section 1515. This year 2015, we are experimenting with two additional joint meetings, September and November, in Tropical Acres Steak-house. The Leadership Teams of both Sections felt that it was something worthwhile to try after Dan Ab-bott, Section 1515 Chair, proposed the idea. We would appreciate the feedback of our members on the holding of these four joint meetings in Ft. Lauder-dale.
The presentation at the last joint membership meeting was on the following topic: Biomedical and Pharmaceutical Manufacturing with Lasers ensuring Quality, Com-pliance, and Safety. The subjects covered were: what is a laser and how is laser light generated, bio-effects of laser radiation on the eye and skin, laser hazard clas-sification and identification, compliance to Federal and State regulations, and vali-dation considerations. We appreciate the well-presented and informative topic de-livered by Tony Imm, founder and CEO of Laser Guardian LLC. Laser Guardian is a consulting firm that is focused on Federal and State laser regulatory compliance. This includes validation of laser processes and safety certification of lasers under FDA 21 CFR Part 1040. Again, anyone interested in volunteering for a position in our Leadership Team please contact our Nominating Chair Mindy Gross at [email protected] Hope to see all of you at the Shula’s Hotel for our October meeting. Check our Website and The Variant newsletter.
Eduardo M. Suárez Chair, ASQ Section 1510 Email: [email protected]
Message from our Section Chair 1510
October 2015
Section 1510 Section 1515
The Variant
Newsletter Editor
Maria Elena Godefroy
Send Contributions to:
INSIDE THIS ISSUE :
ASQ 1510 DINNER
MEETING
2
NEWS 3
ASQ
CERTIFICATION
4
ASQ
RECERTIFICATION
5
ASQ 1510 +
LINKEDLN
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American Society for Quality Southeast Florida
www.asqsefla.org
www.asqpalmbeach.org
Contact Phil Centonze for the next Quality System Audit Training Class
954-684-2642 or at [email protected]
Save The Date!
October 13th, 2015
“ASQ SECTION 1510
DINNER MEETING”
Register Now!!
@
www.asqsefla.org
IMPORTANT MESSAGE TO ALL MEMBERS!!!
Any Section 1510 ASQ member interesting in volunteering on the 1510 Board for the 2016 calendar year should contact Mindy Gross at [email protected].
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ASQ Section 1510 Dinner Meeting
October 13, 2015
Speaker
Mercedes Massana, Founder and CEO of MDM Engineering Consultants
Topic Risk Management
at
Shula’s Hotel 15255 Bull Run Road
Miami Lakes, FL 33014 (305) 821-1150
1510 & 1515 members $15.00 .
(Non-members $26.00)
Registration/Networking
5:45 pm
Dinner: 6:30
Presentation: 7:15 pm
To register go to www.asqsefla.org - Upcoming Events
ASQ SECTION 1510 DINNER MEETING
Speaker: Mercedes Massana, Founder and CEO of MDM Engineering Consultants
Mercedes has over twenty-five years of experience in the Medical Device industry with extensive experience in developing processes within the constraints of FDA and ISO Quality Systems. She has had responsibility for establishing processes and leading engineering groups in Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, and Process Validation. AS CEO of MDM Engineering Consultants, Mercedes provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. She is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). And she is a member of the Board of Section 1510.
Presentation Topic: Risk Management
This presentation will discuss how to design an ISO 14971 compliant approach for medical devices so that risk management activities are integrated into all phases of the product development lifecycle. Discussion topics will include:
Risk management activities integration throughout the development process.
The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated risk management approach.
The importance of maintaining risk management documents in post production.
Information to include in the Risk Management Plan and Report for better auditability.
How to integrate risk management with Corrective Action/Preventive Action activity and Complaints and Non-Conformance processes.
Dinner meeting reservations must be cancelled by the reservation deadline.
Individuals with reservations not cancelled by the deadline will be responsible for the fee.
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Section 1510, the Southeast Florida Section of ASQ, has met the requirements for a Performance Awards & Recognition (PAR) Award for 2014.
This level was achieved by meeting the good stand-ing requirements as well as meeting or exceeding the Member Value metrics and having an increase in Retention %.
On behalf of the Performance Awards & Recogni-tion (PAR) committee, we want to thank you for all of the hard work your leadership team provided to members of the Southeast Florida Section, 1510 this past year, as well as ASQ as a whole.
NEWS
NEW PRICING FOR SECTION 1510 and 1515 MEMBERS!!!
$15.00 NEW PRICING OPTION! Take advantage of your Section membership benefits in-cluding meal if:
You register and pay for the meeting through the PayPal option online prior to 12:00 noon on Sunday, October 11th, 2015.
OR
You register and mail your check postmarked no later than Saturday, October 10th, to: ASQ Section 1510 P.O BOX 823855, Pembroke Pines, FL 33082-3855
Regular pricing of $26 applies to anyone who is not a member of Section 1510 or 1515 and to members of Section 1510 & 1515 who do not meet the registration and pay-ment conditions noted above.
2014 Section 1510 Bronze PAR Award
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Se c t i o n 15 10
A SQ C e r t i f i c a t i o n Re f r e s h er C l as s e s
Class Class Name CEU's Fee When Time Place Instructor
IA Internal Auditing for Quality Systems 1 $275* August
8:30 am to 5:00 pm
One Day Seminar
TBD
Kannan Krishnan CQE, CQA, CMQ/OE, CQIA, CSSBB, CBA
CQT Certified Quality Technician 2.7 $400* January,
August
5:30 pm to 8:30 pm
9 sessions
TBD
Shawn Currie CQE, CRE, CQA, CMQ/OE CSSGB
CMQ/OE Manager of Quality / Organizational Ex-
cellence 2.7 $450* January, July
5:30 pm to 8:30 pm
9 sessions
Dade
Shawn Currie CQE, CRE, CQA, CMQ/OE CSSGB
CQE Certified Quality Engineer 3 $450* March ,
September
5:30 pm to 8:30 pm
10 sessions
TBD
Jim Carbone CBA, CQA, CQE,CMQ/OE Herve Cantave CQE
CSQE Certified Software Engineer 2.4 $375* March ,
September
6:00 pm to 9:00 pm
8 sessions
TBD
Mercedes Massana CSQE, CQA,CMQ/OE,CBA
CQA Certified Quality Auditor 2.4 $375* March,
September 6:00 pm to 9:00 pm TBD
Jim Carbone, CBA, CQA, CQE,CMQ/OE
Shawn Currie CQE, CRE, CQA, CMQ/OE CSSGB
CQIA Certified Quality Improvement Associate 2.4 $375* March,
September
5:30 pm to 8:30 pm
8 sessions
TBD
Kannan Krishnan CQE, CQA, CMQ/OE, CQIA, CSSBB
CQI Certified Quality Inspector 2.4 $375* January, July
6:00 pm to 9:00 pm
8 sessions
Broward
Eleanor Chilson CQE, CMQ/OE, CQA, CQIA
CRE Certified Reliability Engineer 3 $350* January
August
6:00 pm to 9:00 pm
10 sessions
TBD
Shawn Currie CQE, CRE, CQA, CMQ/OE CSSGB
BPR Blueprinting Reading 2.4 $375* TBD
5:30 pm to 8:30 pm
8 sessions
TBD
Eleanor Chilson CQE, CMQ/OE, CQA, CQIA
CCT Certified Calibration Technician 2.4 $375* March ,
September
5:30 pm to 8:30 pm
8 sessions
TBD
Fred King - CCT
CSSBB Six Sigma Black Belt 3 $450* January,
5:30 pm to 8:30 pm
10 sessions
TBD
Kannan Krishnan CQE, CQA, CMQ/OE, CQIA, CSSBB, CBA
August Gustavo Diaz CQE, CSSBB
CSSGB Six Sigma Green Belt Refresher 2.7 $450* April,
September
8:30 am to 5:00 pm TBD
Kannan Krishnan CQE, CQA, CMQ/OE, CQIA, CSSBB, CBA
9 sessions Gustavo Diaz CQE, CSSBB
CSSGB Six Sigma Green Belt Certification 6 $2500* March ,
September
8:30 am to 5:00 pm TBD
Kannan Krishnan CQE, CQA, CMQ/OE, CQIA, CSSBB, CBA
9 sessions Gustavo Diaz CQE, CSSBB
CBA Certified Biomedical Auditor 2.4 $375* January
8 sessions Cordis Jim Carbone, CBA, CQA, CQE,CMQ/OE
August
To participate in an ASQ refresher class, please sign up on the web page at www.asqsefla.org. You do not need to be a member of ASQ to par-ticipate in a class. RU’s are earned for class participation. If you have a question regarding registration or class site, call Amarilis Acosta, Educa-tion Chair, at 305-298-3721 or email [email protected] please sign up at least three weeks before the scheduled class start to assure you have the textbook at first session. Any classes that do not register a minimum of five students will be cancelled. For Certification Exams dates and locations, please visit the ASQ Certification website at www.asq.org. All classes are refresher classes.
*Includes textbooks & materials
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Recertifying?
As you retain your RU’s remember to check that the Recertification Journal Applica-tion form you use is the current version when submitting your recertification pack-age.
If you use a form that has an out of date fee, ASQ National in Milwaukee will not update your certification until their current fee is paid. Your local Section does not set or collect the fees, the fees are collected when the approved recertification package is processed in Milwau-kee.
If you use an outdated form and do not remit the full recertification fee to National, your recertification will be delayed.
You can download the current form from http://asq.org/cert/recertification.
If your membership is not current but you still select the "member" fee, the application will not be processed and your recertification will be held.
In that case, please consider renewing your membership - you'll get the lower member rates for recertifying, and many other benefits as well!"
If you have any questions regarding re-certification, please contact Jim Carbone CQA, CQE, CBA, CMQ/OE, ASQ Southeast Florida Section 1510 Recertification Chair: [email protected] or (954) 817-9797.
ASQ Recertification Guidelines
Have three years passed so quickly that you’re ready to recertify your ASQ Certifications? Some points to consider that will make the process quick and easy for everyone:
1. Provide corroborating documents for the recertification units (RUs) that you claim in your journal application.
2. Make sure that the RUs claimed were earned BEFORE the expiration of your certifica-tion – if not, they will apply to the next certification but not the current certification.
3. If you’re synchronizing two or more certifications, be sure to have enough RUs accumulated for the shortest period, i.e., the certification that expires latest (that you ’re “pulling in” to the same date as the first of the certifications that are expiring).
4. SIGN THE ETHICS STATEMENT on the Recertification Journal application! This is criti-cal – without your signature, the application will not be processed.
5. Enclose payment, made out to “ASQ” not to Section 1510, not to any person. If you wish to make payment by credit card, sign the credit card section AND ALSO BE SURE TO SIGN THE ETHICS STATEMENT – there are TWO different signatures for two different purposes.
6. Please DO NOT send your application by private carrier (DHL, UPS, FedEx, etc.) – private carriers cannot deliver to Post Office boxes.
7. Please DO NOT send your application by Certified Mail or by Express Mail. Certainly these deliver to PO Boxes, but they require in-person signature for receipt which may delay your ap-plication. If you feel you must have delivery confirmation, pay the much smaller cost (less than a dollar) and get delivery confirmation through the post office.
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ASQ Recertification Guidelines (continued)
CALL OR EMAIL Jim Carbone, CQA, CQE, CBA, CMQ/OE, ASQ
Southeast Florida Section 1510 Recertification Chair if you have any questions: [email protected] or (954) 817-9797.
Send your Recertification Journal Packages in either of TWO OPTIONS:
1. Hardcopy – mail to: James Carbone, PO Box 4343, Fort Lauderdale, FL, 33338-4343
2. Electronic – email PDF scan of ALL DOCUMENTATION to [email protected]
For Section 1515 Recertification:
EMAIL Judy Gottesman, CSQE, ASQ at [email protected] Southeast Florida Section 1515 Recertification Chair if you have any questions: [email protected]
Send your Recertification Journal Packages in either of TWO OPTIONS:
1. Hardcopy – mail to: Judy Gottesman, C/O NCCI, 901 Peninsula Corporate Circle, Boca Raton, FL 33487.
2. Electronic – email PDF scan of ALL DOCUMENTATION to Judy
IMPORTANT: You MUST sign the “Applicant Signature and Date” affirming your adher-ence to the ASQ Code of Ethics and the accuracy of your application along with applicable rules related to recertification. If you fail to sign your Recertification Journal Application, your recertification cannot be approved and will be delayed until you provide a signed appli-cation.
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Section 1510 Section 1515
The Variant American Society for Quality Southeast Florida
www.asqsefla.org
www.asqpalmbeach.org
Section 1510 Chair
Eduardo M. Suárez
Website: www.asqsefla.org
Mailing Address: PO Box 823855,
Pembroke Pines, FL 33082-3855
Section 1515 Chair
Dan Abbott : [email protected]
Website: : www.asqpalmbeach.org www.palmbeach.org
ASQ Section 1510 + LinkedIn = Your Knowledge. Your Network. Your Strength.
Our section’s group is active on LinkedIn, the best-known online professional networking channel.
Then press
Join today. Stay in the know. Take part in sharing, net- working, discussions, polls, and a lot more.
Find us by typing ‘ASQ 1510’ under Group Search.
It’s that easy.
Please contact Mercedes Massana Section 1510, for more information at [email protected]