Using Microsoft Excel for Charts, Graphs, and Formulas

September 15th, 2014

Our Next Monthly ASQ 711 Seminar will be held on

Wednesday, September 17, 2014

at 6:30 PM

“Using Microsoft Excel for Charts, Graphs, and Formulas”

Presented by: Duane K. Allen
Senior ASQ Member

We will meet at the:

HomeTown Buffet

When you arrive announce that you are with ASQ.

Dinner: $13.25 / pp

Schedule
6:30 PM:
Arrive & Have Dinner
7:00 PM:
Business & Program

Reservations are not required & Spouses, Significant Persons and Guests are always welcome!

Please Join Us!

QUALITY LEADERSHIP NETWORK

September 11th, 2014

Tuesday, September 16, 20145:30pm to 8:30pm

Location: Baxter BioScience Auditorium
One Baxter Way, Westlake Village CA 91362

Topic: WHAT IS QUALITY LEADERSHIP NETWORK?

Through collaboration, transparency and timely communication, FDA and Industry work together to improve the quality of services and products we provide to the American public and disseminate information that may benefit us all.

Expert: Dr. Marlene Garcia Swider

Dr. Marlène García Swider has served in the FDA for more than 25 years in different capacities including Public Affairs Specialist (working with Congressional issues), Biotech Reviewer, Budget and Planning Analyst, Investigator, and Regulatory Project Manager. Most recently she serves as the Quality System Manager for Los Angeles District Office, FDA.

Takeaways:
• Invitation to be part of QLN: Trough networking, meet other health professionals working toward improving quality of services and products in United States
• Keep informed of FDA regulatory and structural changes that may impact you,
• Collaborate, learn and participate in FDA initiatives

Registration:
Dinner (Sandwiches or Pizza) & soft drinks will be provided.

Seating is limited to the first 40 registrants so sign up soon! Registration closes at noon event day.

ASQ Member $20
Non-member $30
Walkins $30- cash only if seating is available

Registration:
https://www.eventbrite.com/e/quality-leadership-network-tickets-13042653929

For more information contact:
Dora Derashan at (818) 693-6618 or email dderashan@yahoo.com

Leadership Strength II – Building a Symphony of Operational Excellence

September 3rd, 2014

Learn how to project leadership presence and the ability to earn respect at every level of your organization. You will take away techniques and strategies that will build your leadership influence and brand. You will master the ability to build, coach, counsel, inspire and synergize your team. 
 
Who should attend:
Managers and Individuals seeking World-Class Leadership Skills 

 Topics Covered:  
 • How to project leadership and command presence 
• How to build a high performance team   
• How to energize, execute and achieve your goals 
• How to build inspiration and commitment   
• Leadership Strength Part I – The Ultimate Competitive Advantage re-visited
 
What will the seminar cover:
The current economy demands more value added intangibles such as: better communications, greater leadership, trustworthiness, personal authenticity, loyalty, respect and appreciation. It takes a strong and capable leader to inspire, motivate, guide and synergize a team of individuals to willingly take action and achieve those extraordinary results. Discover how good managers become strong, respected leaders and walk away with all the techniques and strategies you need to lead and build brand loyalty and communities of lifelong customers. 

 About our speaker: 
Chris Alexander is the founder and president of Synergy Executive Education, a highly effective change management practice specializing in people centered change. He is an award winning business building strategist, professional speaker, and author of 9 business and personal development books. His Synergy programs have been implemented world wide by Fortune 500 companies, government agencies, non-profit organizations and educational institutions. He has advanced degrees in Organizational Behavior and is an expert at building high performance business teams focused on a shared destiny. 

 Fees
For section 0701 members 
 $149 if registered on or before September 10th
$169 if registered after September 10th
    
For non-members 
$169 if registered on or before September 10th
$189 if registered after September 10th
50% off for Student non members (valid ID required)

For students members (section 0701)
50% discount on member rates

For student non-members
50% discount on non-member rates

Students must be enrolled full time and present a valid ID at the registration table at the day of the event. Contact Arrangements Chair at Arrangements0701@gmail.com for discount code.

   
    When 
Wednesday, September 17, 2014 
9:00 AM to 4:00 PM 
Pacific Time 

Where 
Brandman University 
16355 Laguna Canyon Road, Room #110, Irvine, California 92618 USA 

 REGISTER

ASQ Orange Empire Monthly Dinner Meeting – September 9, 2014

August 25th, 2014

ASQ Orange Empire Monthly Dinner Meeting – September 9, 2014

This is our regular monthly dinner meeting program with two clinics running concurrently, dinner, and an outstanding after dinner presentation. You are welcome to come for the clinics and after dinner presentation WITHOUT buying the dinner. In fact, we welcome you. We will have accommodations for you. This way you still earn the RU and take advantage of the presentations.

PRESENTATIONS

Clinic 1: Avoiding the Dreaded 483: What should you do?
Presented by Tiffany Abrams

Clinic 2: Visual Mind Mapping: creative problem solving
Presented by Linda Krall

Dinner Presentation: Critical Thinking – understanding and applying critical thinking…
Presented by Nick Dayton, PhD

W​HEN
Tuesday, September 9, 2014 5:15 PM – 9:00 PM Pacific Time

WHERE
Doubletree Hotel Santa Ana/Orange County Airport
201 East MacArthur Boulevard, Santa Ana, California 92707 USA

Register

FEES
Clinic 1 or Clinic 2 ONLY (no dinner speaker or meal)
(0701 Member) Complimentary
(Non-0701 Member) $10.00

Clinic 1 or Clinic 2 and Dinner Speaker (no dinner meal)
(0701 Member) Complimentary
(Non-0701 Member) $10.00

Full Package – Clinic 1 or Clinic 2, Dinner, and Dinner Speaker
(0701 Member) $30.00 for a limited time ($40.00 original price)
(Non-0701 Member) $45.00 for a limited time ($55.00 original price)

RSVP by
Friday, September 5 at 11:15 AM for discounted pricing and Fish and Beef dinner selections.

View Event Summary

View Event Agenda

Secrets to Success: Pre-Subs, 510(k)s, and FDB

August 18th, 2014

You are Invited to an Evening Meeting

Secrets to Success
Pre-Subs, 510(k)s, and FDB  

 

What you need to know to write and submit successful Pre-Submissions and 510(k)s and how to be a compliant medical device manufacturer within the State of CA.

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Wednesday, September 10, 2014

5:30 – 8:45 pm 

Location:   

HORIBA Medical 

9755 Research Drive, Irvine, CA  92618

Program Host: 

Azita Hedayati, MS, CMQ/OE, CQA, Director, Regulatory & Compliance HORIBA Medical 

 

Program Manager and Moderator:

Kim Walker, MS, RAC (US & EU), Global RA & QA Consultant
Kim Walker Consulting

Presenters: 

Harlan Loui, Medical Device Safety Section Chief, State of CA, Public Health Department, Food and Drug Branch

Deborah Morris, Senior Director, Clinical, Myraqa, Inc.

Barb Stevens, RAC, Regulatory Consultant

Synopsis: 

The 510(k) program has been a hot topic lately and the FDA has implemented improvements to the review process. Many companies (large and small) struggle with creating comprehensive submissions that minimize FDA questions and, conversely, delays to market entry. Come learn how Pre-Submissions can improve your 510(k) clearance times, the basics of 510(k) submissions, hear good submission practices from 510(k) proficient professionals, and learn about the recent changes to the Pre-Submission and 510(k) FDA review processes.

 

Additionally, many California-based companies do not know that the State of CA requires medical device manufacturers to obtain Medical Device Manufacturing Licenses prior to conducting validation studies using human samples or subjects and prior to placing a device on the market. During this program, you will hear directly from the State of CA Food and Drug Branch about the regulation governing medical devices in the State of CA, inspection requirements or opt-out options, and the new online export certificate application process.

Please join us for these learning opportunities and open discussions with seasoned industry professionals and regulators.

 

 

REGISTRATION DEADLINE:  September 5th

No on-site or walk-in registrations will be accepted for this program.

Space is limited at this facility and registrations will be accepted on a first-come-first-serve basis.

 

 

Schedule of Presentations:

5:30 – 6:00 pm           
Registration, Networking, and Refreshments

 

6:00 – 6:45 pm
FDB Updates and Discussion on New Online Export Certificate Application Process

Harlan Loui, Medical Device Safety Section Chief, State of CA, Public Health Department Food and Drug Branch

 

6:45 – 7:30 pm
Pre-Submission Program and Best Practices

Deborah Morris, Senior Director, Clinical, Myraqa, Inc.

 

7:30 – 8:15 pm             

510(k) FDA Review Process and Submission Best Practices

Barb Stevens, RAC, Regulatory Consultant

 

8:15 – 8:45 pm                         

Panel Discussion, Speaker Q&A, and Closing Remarks

 

Cost:

OCRA Members: $50

Non Members: $100 (includes OCRA Membership for one year)

Government and Students: $25

FREE for HORIBA Employees (please email Azita to be added to the list)

 

 

Registration fee includes light dinner, beverages and parking.

 

After the meeting, electronic access to the presentations will be made for all attendees.  

 

Dress code is business casual.

 

  

Click Here to Download the Event Flyer

Is it a Recall? Now what do we do?

August 18th, 2014

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Thursday, August 28, 2014
Noon – 5:30 pm 

Location:   

Irvine Marriott

18000 Von Karman

Irvine, CA  92612

949-553-0100  

 

Program Managers:

Mugdha Dongre, Regulatory Affairs Specialist, Bausch + Lomb

James (Rusty) Lusk, Principal, Quality Systems International

Janet Rubin-Halpert, RAC, CQE, CBA, CQA

 

Speakers:

Phil Johnson, Sr. Director Regulatory & Quality EU, Quintiles Consulting

James (Rusty) Lusk, Principal, Quality Systems International

Denise McEachern, Consultant

Thanh Tran, District Recall Coordinator, FDA Los Angeles District

  

Synopsis:

Many questions arise when complaints affecting the health of patients are received or design/manufacturing non-conformances are identified after product released to the market. Is the product required to be recalled or is it required to be corrected? Recalls have always been a vital part of the health industry. There are many ways to execute a recall. However, the most effective and efficient way needs to be employed.

 

This program will provide the nuts and bolts for implementing and managing an effective recall for all the major fields of the health industry such as drugs, biologics, medical devices, electronic and radiation devices, dietary supplements, and combination products. The session will also touch base on products involved in clinical trials along with methods to deal with unanticipated adverse effects. The session will walk you through the steps starting from identifying a recall and ending with effectiveness checks required to close the recall.

 

The session will close with case studies and a discussion panel, which will help the attendees to take away an effective plan/checklist to implement the recall process.

 

    

 

 

Agenda:

Noon – 12:45 pm

Registration, Networking and Light Buffet Lunch

 

12:45 – 1:30 pm

Identifying and Strategizing Recalls

James (Rusty) Lusk, Principal, Quality Systems International

This session will be focused on identifying whether it is a recall and follow through to its strategic planning for effective execution.

 

1:30 – 2:15 pm

FDA Requirements

Thanh Tran, District Recall Coordinator, FDA Los Angeles District

FDA requirements and what FDA wishes to see when a recall is initiated and during its compliance, inspection and close out. This session will also discuss the steps in the recall process and when industry should involve the FDA.

 

2:15 – 2:30 pm

Ice Cream Break

 

2:30 – 3:10 pm

Execution of a Recall

Denise McEachern, Consultant

We will discuss the initiation, internal inspection and compliance with FDA requirements and effectiveness checks for efficient close out of a recall. This session will also touch base upon the handling of a recall in the global market focusing on major markets like Australia, Canada, EU, Japan and US.

 

3:10 – 3:50 pm

Post Market Surveillance to prevent Recall

Phil Johnson, Sr. Director Regulatory & Quality EU, Quintiles Consulting

This session will walk through the steps one should take to reduce recalls in the industry and also talk on maintenance factors that should be considered throughout the product’s life cycle which could prevent recalls or Field Safety Notices.

 

3:50 – 4:05 pm

Break

 

4:05 – 5:00 pm

Case Study and Q&A

 

5:00 – 5:20 pm

Networking 

 

 

Cost:

OCRA Members: $155

Non Members: $205

Government and Students: $75

 

Registration fee includes light lunch, beverages, ice cream break and parking. After the meeting, electronic access to the presentations will be made for all attendees. Dress code is business casual.

  

 Click Here to Download the Event Flyer   

Process Validation: Proactive and Robust Validation Programs

July 30th, 2014

ASQ Orange Empire Monthly Dinner Meeting – August 12, 2014

This is our regular monthly dinner meeting program with two clinics running concurrently, dinner, and an outstanding after dinner presentation. You are welcome to come for the clinics and after dinner presentation WITHOUT buying the dinner. In fact, we welcome you. We will have accommodations for you. This way you still earn the RU and take advantage of the presentations.

PRESENTATIONS

Clinic 1: PROCESS VALIDATION: PROACTIVE & ROBUST VALIDATION PROGRAMS
Presented by Peter Lindwall

Clinic 2: ASQ WORLD CONFERENCE KNOWLEDGE SHARING – IMPROVING BUSINESS
Presented by Ed Matthews

Dinner Speaker: SOCIAL MEDIA MADE SIMPLE AND LEVERAGING LINKEDIN
Presented by Nick Cavarra

W​HEN
Tuesday, August 12, 2014 5:15 PM – 9:00 PM Pacific Time

WHERE
Doubletree Hotel Santa Ana/Orange County Airport
201 East MacArthur Boulevard, Santa Ana, California 92707 USA

Register

FEES
Clinic 1 or Clinic 2 ONLY (no dinner speaker or meal)
(0701 Member) Complimentary
(Non-0701 Member) $10.00

Clinic 1 or Clinic 2 and Dinner Speaker (no dinner meal)
(0701 Member) Complimentary
(Non-0701 Member) $10.00

Full Package – Clinic 1 or Clinic 2, Dinner, and Dinner Speaker
(0701 Member) $30.00 for a limited time ($40.00 original price)
(Non-0701 Member) $45.00 for a limited time ($55.00 original price)

RSVP by
Friday, August 8 at 11:15 AM for discounted pricing and Fish and Beef dinner selections.

View Event Summary

View Event Agenda

ISO 9001:2015 – From Committee Draft to Draft International Standard

July 23rd, 2014

ASQ Orange Empire Quarterly Breakfast Meeting

“ISO 9001:2015 – From Committee Draft to Draft International Standard. An update of the world’s most popular QMS standard.”

Presented by:
Manuel Marco with the DNV GL Business Assurance in North America.

When
Saturday, July 26, 2014 10:00 AM – 12:00 PM Pacific Time

Where
BJ’s Brewhouse
24032 El Toro Road, Laguna Hills, California 92653 USA

Fees
ASQ Section 0701 Member $15.00 for a limited time ($18.00 original price)
Non Section 0701 Member $18.00 for a limited time ($21.00 original price)

Register

Oncology Research Nurses, Los Angeles

July 22nd, 2014

Oncology Research Nurses (Contract/Perm)

Immediate need for experienced Oncology Research Nurses to work at a large clinical trial site in Los Angeles.

1) One Research Nurse is needed to fulfill a 3-4 month contract
2) Second Research Nurse is needed as a full-time direct hire

Requirements:
*ASN, BSN, MSN
*OCN a plus
*Must have 1 year Oncology clinical trials experience

Contact:

Jan Clements

(818) 552-2105

jclements@meirxrs.com

ISO 9001:2015 – From Committee Draft to Draft International Standard

July 16th, 2014
ASQ Orange Empire – Quarterly Breakfast Meeting – July 26, 2014

American Society for Quality, Orange Empire Section,
Quarterly Breakfast Meeting,
July 26, 2014
10:00 am – 12:00 pm
Saturday, July 26, 2014 10:00 AM  – 12:00 PM
Pacific Time
BJ’s Brewhouse
24032 El Toro Road, Laguna Hills, California 92653 USA

“ISO 9001:2015 – From Committee Draft to Draft International Standard. An update of the world’s most popular QMS standard.”

As over 1.1 Million organizations around the World have been certified to the ISO 9001 standard, there is a tremendous anticipation to the upcoming changes of the ISO 9001 standard. This presentation will provide an update on the current changes and status of the 2015 revision of ISO 9001.
ASQ Section 0701 Member $15.00 for a limited time  ($18.00 original price)
Non Section 0701 Member $18.00 for a limited time  ($21.00 original price)

View Event Summary

View Event Agenda
Thursday, July 24, 2014

Register