ASQ Quality and Safety Conference Features Food, Drug, Cosmetic Experts

April 8th, 2014

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Keeping Curiosity Cool (or Warm): Thermal Control of the Newest Mars Rover

March 27th, 2014

When:              Tuesday, April 8, 2014

6:30 PM – Socialize / Dinner

7:00 PM – Presentation

Where:            NuSil Technology LLC, 1050 Cindy Lane, Carpinteria, CA

Cost:                 $15 (includes a sandwiches, salad and drinks)

 

RSVP:              Fishman_Sebastian@Allergan.com

(No later than Monday, April 7th at noon)

Speaker:       Michael Brown

Topic:             Keeping Curiosity Cool (or Warm): Thermal Control of the Newest Mars Rover

To generate electrical power, the Curiosity rover currently in operation on Mars uses a radioisotope thermal power generator instead of the solar panels used on prior missions.  This type of power generator establishes both challenges and opportunities for the rover’s thermal design.  A Goleta firm provided critical components that allow the rover to control the temperature of its sensitive science instruments utilizing the waste heat recovered from the power generator during cold Martian nights.

Speaker

Biography:   Michael Brown is the Director of Engineering and Program Management for Pacific Design Technologies, which designs and builds thermal control equipment for aircraft, ground and space vehicles.  Mr. Brown has been employed in the aerospace field for twenty-eight years and has served in a variety of roles at Fairchild Control Systems Company, Honeywell Aerospace, SkyWest Airlines, and Pacific Design Technologies. He has also consulted for Parker Hannifin, Boeing and other firms.  He was the systems engineer for the MD-11, B-777 and B-717 environmental control systems while employed at Honeywell, and has performed engineering and program management functions on a variety of space and airborne liquid cooling systems during his tenure at Pacific Design Technologies.  He was a captain and line check airman while employed at SkyWest Airlines.  Mr. Brown holds a bachelor’s degree in Mechanical Engineering from Cal Poly Pomona and an Airline Transport Pilot rating from the FAA.

Leadership Strength-the Ultimate Competitive Advantage

March 14th, 2014

Discover how good managers become strong leaders. Walk away with techniques and strategies that lead to building brand loyalty and communities of lifelong customers, while strengthening your capacity to guide, motivate and synergize your team.

Who should attend:
Managers and Individuals seeking World-Class Leadership Skills

 Topics Covered:
• How to become a strong leader and powerful coach
• How to determine your strengths and the strengths of your team
• How to build and focus high-performance teams on a shared destiny
• How to deal with conflict and conduct crucial conversations
• How to create zones of inspiration and profitable work environments

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 March 31st
$169 if registered after March 31st

For non-members
$169 if registered on or before March 31st
$189 if registered after March 31st

 When
Thursday, April 10, 2014
9:00 AM to 4:00 PM
Pacific Time

Where
Brandman University
16355 Laguna Canyon Road, Room #111, Irvine, California 92618 USA

REGISTER

Natural Products Expo West 2014

March 11th, 2014

Food Expo West 2014

A BIG  THANK YOU to Sarah Kormos at New Hope Natural Media for giving ASQ Food, Drug, & Cosmetic Division an opportunity to check out the Natural Products Expo West on Friday at the Anaheim Convention Center. The exhibit halls were packed with buyers and sellers of all natural foods, beverages, supplements, personal care products and etc.  It was an amazing educational experience to learn more about all natural, organic, non-GMO and gluten free products in the market today.

Leading Teams (From the Front or From Within) Part 3 of 3

March 10th, 2014
Leading Teams (From the Front or From Within) Part 3 of 3
Join us for a webinar on March 19
Space is limited.
Reserve your webinar seat now at:
https://www4.gotomeeting.com/register/815483791
·         This series of three one hour webinars provides leaders (management and non-management) with a strong foundation in working within teams to produce outstanding results. Each installment covers different elements of those things with which a leader must be concerned.o   The first hour dealt with selecting team members and setting the tone for team. In other words, in establishing leadership.

o   The second hour is about interfacing with team members face-to-face regarding the daily business of the team. How you lead has a huge impact on how (and whether) you are followed, and knowing how to create safety and openness is essential for getting the results you want.

o   The third hour is about conducting conversations on matters over which there are differences (sometimes strong differences) of opinion. Being able to channel diverse perspectives into a complete picture is something that few people approach with a plan, but a plan (and the knowledge of how to create on) is just what you need in order to navigate the sometimes difficult passage from conflict into real understanding.

Gregg Oliver is the Principal at Pathfinder Communication, LLC, an Influence and Communication training firm in San Diego, CA. He teaches leadership concepts and specific techniques used to conduct productive conversations, how to be influential and develop and maintain amazing business relationships. The author of the weekly newsletter “High Performance Communication”, he holds a BS in Quality Engineering, an MS degree in Quality Systems Management and is a member of the adjunct faculty at National University. He has worked as a distinguished individual contributor and manager in engineering and manufacturing businesses for over 35 years.

 

Title: Leading Teams (From the Front, or From Within) Part 3 of 3
Date: Wednesday, March 19, 2014
Time: 6:00 PM – 7:00 PM CDT

 

After registering you will receive a confirmation email containing information about joining the webinar.

Leadership Strength – The Ultimate Competitive Advantage

March 10th, 2014

Discover how good managers become strong leaders. Walk away with techniques and strategies that lead to building brand loyalty and communities of lifelong customers, while strengthening your capacity to guide, motivate and synergize your team.

Who should attend:
Managers and Individuals seeking World-Class Leadership Skills

 Topics Covered: 
• How to become a strong leader and powerful coach
• How to determine your strengths and the strengths of your team
• How to build and focus high-performance teams on a shared destiny
• How to deal with conflict and conduct crucial conversations
• How to create zones of inspiration and profitable work environments

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: 
Chirs 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 expert at building high performance business teams focused on a shared destiny.

Fees
For section 0701 members
$149 if registered on or before March 31st
$169 if registered after March 31st

For non-members
$169 if registered on or before March 31st
$189 if registered after March 31st

 When
Thursday, April 10, 2014
9:00 AM to 4:00 PM
Pacific Time

Where
Bradman University
16355 Laguna Canyon Road, Room #111, Irvine, California 92618 USA

REGISTER

Knowing the best practices in applied statistics

March 10th, 2014

The Southern California Discussion Group of the ASQ Biomedical Division in association with ASQ SFV section 706 presents:

 “Knowing the best practices in applied statistics”

Expert: Greg Golamirians

Greg Golamirians is Sr. Manufacturing Engineering Manager at Boston Scientific Neuromodulation division in Valencia, CA. He is also the site technical lead, mentor and certified trainer for engineering essentials program to champion the application of statistical tools and methodologies in problem solving and process improvement for sustaining and new product development disciplines.

Greg has 17 years of experience in various industries including, medical device, semiconductor, aerospace, automotive, and other industrial applications as various engineering and managerial roles.

Greg holds a MSc. in Industrial and Manufacturing Engineering as well as an MBA from California State University Pomona. He is an ASQ member and holds CSSBB,CQE, CRE, CQA and CQLA certifications.

 

Date: Tuesday, March 11, 2014     5:30pm to 8:30pm

LOCATION:

Boston Scientific Neuromodulation

25129 Rye Canyon Loop-Building 28 Training Theater, Valencia, CA 91355

Dinner & 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/applied-statistics-dos-donts-best-practice-for-process-improvement-tickets-10746165069

Risk Based Environmental Monitoring (EM)

March 10th, 2014
ASQ Biomedical Division

 

This message is sent by the Southern California Discussion Group of the Biomedical Division of ASQ of the American Society for Quality as a benefit of your membership.
____________________________________________________________________
The Southern California Discussion Group of the ASQ Biomedical Division Presents:

Risk Based Environmental Monitoring (EM)  
How to use risk to ensure your EM Program is value added & efficient
           An Industry Roundtable Discussion   
                      
Tuesday, March 25, 2014
5:30pm to 8:30pm
Topic:   
Risk Based Environmental Monitoring and Efficiencies Gained With Use of an Automated System (Novatek)

Non-viable air, viable air, and surface monitoring of controlled environments is not a new concept and has been a regulatory requirement for many years. In the past, many companies selected Environmental Monitoring (EM) sample locations based on a grid approach of dividing up the rooms and taking samples inside all of the grids. Current regulatory requirements involve taking risk based approaches in the manufacturing of products, including Environmental Monitoring. Does your current EM Program consist of many floor and wall sample locations? Do you ever ask yourself if the data you are collecting every week/month/year in your EM Program is value added?

Current regulatory expectations are that your EM Program is based on risk of microbial contamination in your process. Formal risk assessments should be performed to justify your EM sample site locations and frequencies. In doing so, your EM Program will ensure that the data you are collecting is meaningful and can help to identify potential contamination problems in your products and processes. This presentation will discuss how to establish a risk-based Environmental Monitoring Program. During this session we will discuss how to set up a new Environmental Monitoring Program based on risk as well as how to perform a reassessment of your current Environmental Monitoring Program to re-establish sampling locations and frequencies based on results of your risk assessments coupled with the knowledge gained from your current EM Program historical data.

Once you have a risk based EM Program in place, you need to manage the data you are collecting. A great way to gain efficiencies is by using an automated system for environmental monitoring. The Novatek Environmental Monitoring data management and trending software system will be presented.

Takeaways:
* How to perform an Environmental Monitoring risk assessment unique to your manufacturing process
* Recent changes in guidance documents and regulations for EM Programs including contamination control rates, risk based sample selections and sampling frequencies
* Learn how to optimize your EM Program with use of an automated system while gaining efficiencies

Please bring your questions, experiences, and other commentary to make this a more valuable experience.

 

Experts: 
Marsha Stabler Hardiman
has over 20 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha has a Bachelors in Biology from Western New England University in Springfield, MA. Marsha is an expert in industrial Microbiology test methods from environmental monitoring (EM) and utility system microbial testing to intermediate product testing through final product sterility testing. Marsha also served as a Microbiology Expert – Notified Body regulatory inspector for CE certification of medical devices and has extensive knowledge in quality systems. Over her career, Marsha has established numerous EM programs for many different medical device and pharmaceutical companies.
Marsha is active in industry and currently serves on the Parenteral Drug Association (PDA) Science Advisory Board; is leading a PDA Task Force on Microbial Data Deviations; serves on the PDA Microbiology Meeting Planning Committee and has been the chair of the PDA Annual Meeting. Marsha also serves as a voting member on the ISO 14644 Liquid Chemical Sterilization Working Group.

Marsha is a Senior Consultant for Concordia ValSource and in this role helps companies implement quality risk management into their quality management systems and validation programs. Marsha currently helps companies reassess their existing EM programs and re-select sample locations based on risk
Cheryl Zaman-Zadeh, MS
is the Director of Technical Sales at Novatek International where she has been for over 15 years. She has played a key role in assisting many small and large organizations define their user requirements in order to fully automate their Environmental Monitoring process. She has experience in applying solutions to the Pharmaceutical, Medical Device, BioTechnology and Food Industry in the area of root cause analysis, the application of process improvement by virtue of continuous feedback loops, compliance, statistical analysis and risk based management.

 

She is an international presenter and has previously presented on topics of Environmental Monitoring and Quality Systems in various conferences such as Local California PDA, IVT, AOAC (southern California) and IPA.

 

To Register:

Registration:
Dinner & drinks will be provided.   
Seating is limited to the first 40 registrants, so sigh up soon!  
Registration closes at noon event day.  
Location:  Abbott Medical Optics
                  1700 E. Saint Andrew Place, Santa Ana, CA  92705

 

Member      

Early Registration $20- / After March 20 $25
Non-member  
Early Registration $30- / After March 20 $35
Students
Early Registration $15-
(must show valid School ID at event registration table for entrance) 
Walkins $35- (cash only) if seating is available

 

For more information, contact:
Tiffany Abrams at (714) 247-8572 or email:

 

Leadership Strength – The Ultimate Competitive Advantage

March 6th, 2014

Discover how good managers become strong leaders. Walk away with techniques and strategies that lead to building brand loyalty and communities of lifelong customers, while strengthening your capacity to guide, motivate and synergize your team.

Who should attend:
Managers and Individuals seeking World-Class Leadership Skills

 Topics Covered:
• How to become a strong leader and powerful coach
• How to determine your strengths and the strengths of your team
• How to build and focus high-performance teams on a shared destiny
• How to deal with conflict and conduct crucial conversations
• How to create zones of inspiration and profitable work environments

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:
Chirs 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 expert at building high performance business teams focused on a shared destiny.

Fees
For section 0701 members
$149 if registered on or before March 31st
$169 if registered after March 31st

For non-members
$169 if registered on or before March 31st
$189 if registered after March 31st

 When
Thursday, April 10, 2014
9:00 AM to 4:00 PM
Pacific Time

Where
Bradman University
16355 Laguna Canyon Road, Room #111, Irvine, California 92618 USA

REGISTER

Discover the Secrets of Preparing Written Procedures that Work

March 5th, 2014

ASQ Orange Empire Monthly Dinner Meeting – March 11, 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: Success in Data Acquisition,
Presented by Michael Scofield 

Clinic 2: Discover the Secrets of Preparing Written Procedures that Work!,
  
Presented by David C. Markovitz

Dinner Speaker:  Understanding and Implementing ISO/IEC 17025:2005,
Presented by Bob Mehta.

WHEN
Tuesday, March 11, 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, March 7 at 11:45 AM for discounted pricing and Fish and Beef dinner selections.

View Event Summary

View Event Agenda

RSVP
Friday, March 7, 2014