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August 31st, 2016

FSMA Preventive Controls for Human Foods CFR 21 Part 117

FSMA Preventive Controls for Human Foods is a 5-week class offered at Miramar college starting Wednesday, October 5th from 9am-2pm.  Attendees of the class will earn a certification to become the Qualified Individual for the United States Food & Drug Administration (FDA) regulation on Preventive Controls for Human Foods.

WHEN Wednesday, October 19, 2016 at 9:00 AM – Wednesday, November 16, 2016 at 1:00 PM (PDT)

WHERE San Diego Miramar College – 10440 Black Mountain Road, San Diego, CA 92126 – View Map

Earn a Certificate of Training from Food Safety Preventive Controls Alliance

Read the rest of this entry »

August 29th, 2016

Joint Networking Event: ASQ, PDA and SoCalBio

Thursday, October 6, 2016 from 4:00 PM to 8:30 PM (PDT), Hilton Irvine/Orange County Airport, 18800 MacArthur Boulevard, Irvine, CA 92612

FDA 483 Trending Topics and Solutions

Joint Networking Event with PDA, ASQ and SoCalBio
  • Keynote: Dr. Marlene Garcia Swider, FDA Quality System Manager
  • Technical Session: FDA 483 Trending Topics and Solutions
  • Table-top Exhibits
  • Speed Networking
  • Western Theme (including Best Cowboy Attire contest)
  • Gourmet Buffet, Wine & Beer, Cash Bar
  • Raffle Prizes
  • transport from San Diego, Los Angeles and Thousand Oaks

Read the rest of this entry »

August 24th, 2016

Compliance of the Dietary Supplement Industry

Event at FDA Los Angeles District Office, Irvine CA on Thursday, November 17, 2016 at 7:30 AM – Download a PDF Flyer of the Dietary Supplements Industry Compliance workshop

Overview

Compliance of the Dietary Supplement Industry is critical under FSMA
It has been more than 6 years since the final implementation of 21CFR Part 111. We continue to see warning letters issued by the FDA to the industry for non compliance with the regulations.

This is a clear indication that there is still a need for better understanding of the regulations and alignment between the agency and the industry. And now we have FSMA (Food Safety Modernization Act), signed into law by President Obama in January 4, 2011. FSMA Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in  Read the rest of this entry »

August 1st, 2016

FSMA Compliance Workshop 2016

Thursday, September 22, 2016 from 7:00 AM to 2:30 PM (PDT)

Supplier Verification Plan of FSMA (Food Safety Modernization Act) & Supplier Risk Management, Controls and Audits

FSMA will impact your food business. Find out how and what to do about it. This is a free half day workshop on Food Safety and Modernization Act (FSMA) compliance.

Breakfast and refreshments are sponsored by the American Society for Quality (ASQ) Food, Drug & Cosmetic Division, the Quality Leaders Network (QLN) Food Group, RxRS Apprenticeship Program.

Event Ended

Recap / Downloads / Presentations

Agenda FSMA Compliance Workshop 2016

January 22nd, 2016

Personality Profiling: STEM Professionals in the New Economy

STEM Professionals need a range of skills to succeed in the new economy. Learn what key characteristics employers are looking for in technical hires.

ASQ Inland Empire Sections 706 and 711 will be profiling the STEM professional for the new economy that will be presented by our very own Rosemarie Christopher.

In this day and age, companies are being more selective as far as educational background, social media reputation, personality profiling and Read the rest of this entry »

October 2nd, 2015
ASQ Certified HACCP

Certified HACCP Auditor (CHA) and
Certified Quality Improvement Associate (CQIA)
Exam Review Workshops

Thursday, November 5, 2015
7:30am-5:00pm

NOAA USDC Seafood Inspection Program
501 West Ocean Blvd., Long Beach, CA 90802

REGISTER NOW!  https://asqchacqia2015.eventbrite.com

Are you ready to take the CHA or CQIA Exam? Come and join us for a full day CHA/CQIA  Exam Review Workshop for only $99! You will have the option to take the test the following day as long as you Read the rest of this entry »

August 17th, 2015

FSMA Compliance Workshop 2015

 

FSMA Compliance Workshop

Download the PDF flyer

FSMA will impact your food business. Find out how and what to do about it. This is a free half day workshop on Food Safety and Modernization Act (FSMA) compliance.

Breakfast and refreshments are sponsored by the American Society for Quality (ASQ) Food, Drug & Cosmetic Division, the Quality Leaders Network (QLN) Food Group, RxRS Apprenticeship Program and Food Safety Net Services.

Overview

FSMA is designed to insure food quality from the farm to fork. FSMA requires all Read the rest of this entry »

April 8th, 2015

Risk Based Auditing Fundamentals

You are Invited to an Evening Meeting

 

Risk Based Auditing Fundamentals

    

Orange County Regulatory Affairs Discussion Group

 

Tuesday, April 21, 2015
4:00 – 7:00 pm

Read the rest of this entry »

March 4th, 2015

ASQ Northeast Conference 2015

Friday, April 10, 2015

7:30 a.m. – 5:00 p.m.

410 George Street, New Brunswick, NJ 08901 Read the rest of this entry »

March 2nd, 2015

FIBR Meet Your Inspectors Forum

FIBR Meet Your Inspectors Forum was held on Wednesday May 30, 2015. Discuss around Semonella Stanely Outbreak featuring FDA and USDA

Embassy Suites (8425 Firestone Blvd., Downey, CA 90241) Read the rest of this entry »

February 2nd, 2015

FIBR Networking Dinner 2015

2015 Chinese New Year Networking Dinner

Network with Food Industry Professionals from FIBR, United Ag, Sabor Latino, FCG,
Vernon Chamber of Commerce!

Details

Thursday, February 26, 2015
5:30 p.m. to 8:30 p.m. Read the rest of this entry »

January 8th, 2015

2015 Southern California Food Industry Conference

Button Up for the Winds of Change 

Labels, Regulations, and Consumer Expectations

 

Wednesday March 4, 2015 9am – 3pm Read the rest of this entry »

November 17th, 2014

Continuous Improvement- Where, Why, How & What Matters?

11/19/14 @ 6::00 PM Read the rest of this entry »

November 17th, 2014

Fundamentals of Data Quality

Fundamentals of Data Quality held on Wednesday, November 19, 2014 at 6:30 PM featuring Michael Scofield, Assistant Professor of Health Information Mgmt

Read the rest of this entry »

October 17th, 2014

Outsourcing 101

  

You are Invited to the Joint Fall Conference 

 

Sponsored by

San Diego Regulatory Affairs Network (SDRAN)

and 

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Wednesday, November 19, 2014  Read the rest of this entry »

October 17th, 2014

Regulatory Inspections and How to Manage Them

You are Invited to an Evening Meeting

Regulatory Inspections
and How to Manage Them   

 

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Wednesday, November 5, 2014 

5:30 – 9:00 pm 

Read the rest of this entry »

October 17th, 2014

Precision  Medicine: A Medical Miracle or Ethical Nightmare?

The Precision Medicine presentation will explore the concept of precision medicine and how it impacts the conduct of oncology clinical trials, regulatory guidance, subject recruitment, and the protection of human subjects participating in research. Learn to recognize the therapeutic misconception and how it impacts patient, caregiver and investigator/physician in the decision-making process. We will debate the concept of “hope” and “autonomy” and how it impacts patient/caregiver decisions regarding clinical trials when research subject is facing a life-threatening disease.Date(s): Nov 6 2014, 05:00 PM to 07:00 PM

Location: CareFusion Corporation Read the rest of this entry »

October 17th, 2014

The Reproducibility Crisis in Biomedical Research

New quality practices developed by the ASQ FD&C Division could change the trend in the Reproducibility Crisis in Biomedical Research!

“The productivity of modern drug development has been steadily Read the rest of this entry »

October 17th, 2014

NDA Submission Planning & Management from the Medical Writer’s Perspective

The session “NDA Submission Planning & Management from the Medical Writer’s Perspective” will orient the audience to New Drug Application (NDA) structure, the typical challenges faced by the medical writers during the authoring and review process, and strategies for messaging and preparing for internal and agency review.

Saturday, Oct 25, 2014 Read the rest of this entry »

October 14th, 2014

Supplier Quality Management: A Risk Based Approach

This month’s Section 706 event will take place on Wed, October 22, 2014 Read the rest of this entry »

October 13th, 2014

8D (Eight Disciplines) Problem Solving

Wednesday, October 15, 2014

at 6:30 PM Read the rest of this entry »

October 13th, 2014

The Global 8D Problem Solving Process8D Problem Solving, like a rubix cube has a lot of elements in play

8D Problem Solving Process Topics Covered Wednesday, November 20, 2014:
* Understand the purpose and objectives of each phase of the 8D Problem Solving Process
* Learn how to apply and utilize key problem solving tools in each phase of the 8D Problem Solving Process
* Apply some of the problem solving tools and key learning points on a simple case study
* Use of assessing questions at the end of each phase of the 8D Problem Solving Process to ensure proper execution of each phase Read the rest of this entry »

October 13th, 2014

Lean Six Sigma Principles Applied to Health Care

Presented by Michelle Kimbro, MBA, MBB
THIS Wednesday,  10/15/14 @ 6::00 PM.      
 Biosense Webster

15715 Arrow Highway, Irwindale, Ca

 

6 – 6:30 pm – Registration, Networking and Dinner

6:30 – pm – Welcome, Announcements and Introductions

6:45 pm – Speaker

8:15 pm – Q & A

8:30 pm – Evaluation and Raffle Drawings

8:45 pm – Adjournment

If you want a dinner selection, you must choose an option.

 

Register Here or copy and cut this link: http://www.cvent.com/d/m4qggx

Members $10, Non-members $15, Students $10

(.3 R.U.s Awarded)

 

To encourage interaction, seating is limited to the first 40 registrants, so sign up soon!

For questions, contact:

Event Coordinator – Jean (Flores) Tedrow at 909-322-2011

Abstract:

The manufacturing industry has successfully used lean management principles for decades and those same lean principles can be applied to the delivery of health care.

Even though health care is different in many ways from manufacturing, there are many similarities. Providing health care for a patient or building a car, workers must rely on multiple, complex processes to accomplish their tasks and provide value to the patient or customer. Waste -of money, time, supplies, or good will – decreases value.

The case study in this presentation of lean thinking in health care demonstrates that lean principles can have a positive impact on productivity, cost, quality, and timely delivery of services.

About 

Michelle Kimbro, MBA, MBB

Lean Six Sigma Consultant | Principal

Michelle Kimbro is the founder of Polaris Healthcare Consulting, which specializes in process re-engineering and improvement utilizing techniques designed to enable healthcare organizations to achieve top performance. She also provides expertise on connecting innovative Health IT solutions with processes to enhance services and improve the delivery of patient care.

Michelle is a Lean Six Sigma Master Black Belt and consultant with experience leading performance improvement initiatives for large health care delivery systems and over 18 years of clinical experience in acute and outpatient settings. She is a MBA graduate from the University of Redlands, School of Business.

She currently holds the position of Secretary for the Society of Healthcare Improvement Professionals (SHIP) and in her spare time actively volunteers for Santa Claus, Inc.

Read the rest of this entry »

October 2nd, 2014

Fortified Rice Particles – Dinner Discuss with SCIFTS Oct 15, 2014field growing fortified rice

DATE: October 15, 2014
Location: Angelo & Vinci’s Ristorante
550 North Harbor Blvd.
Fullerton, CA 92832
Directions
Time: 4:30 p.m. – Executive Meeting
5:30 p.m. – Social Hour
6:30 p.m. – Dinner Hour
Speaker: Dr. Olive Li
Topic: Fortified Rice Particles

Read the rest of this entry »

October 2nd, 2014

Oh no, you got a 483 letter…..now what?

ASQ Orange Empire Monthly Dinner Meeting – October 14, 2014 Read the rest of this entry »

September 30th, 2014

Understanding How FDA Looks at Outsourcing

When:  Thursday, October 9, 2014 at 6:00 PM

Where:  The Wyndham, 17941 Von Karman Ave., Irvine, CA 92614

Read the rest of this entry »

September 15th, 2014

Using Microsoft Excel for Charts, Graphs, and Formulas

Our Next Monthly ASQ 711 Seminar will be held on

Wednesday, September 17, 2014

at 6:30 PM Read the rest of this entry »

September 11th, 2014

QUALITY LEADERSHIP NETWORK

Tuesday, September 16, 20145:30pm to 8:30pm Read the rest of this entry »

September 3rd, 2014

Leadership Strength II: Building a Symphony of Operational Excellence

 When
Wednesday, September 17, 2014
9:00 AM to 4:00 PM
Pacific Time  Read the rest of this entry »

August 25th, 2014

ASQ Orange Empire Monthly Dinner Meeting – September 9, 2014

WHEN
Tuesday, September 9, 2014 5:15 PM – 9:00 PM Pacific Time Read the rest of this entry »

August 18th, 2014

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

Wednesday, September 10, 2014 Read the rest of this entry »

August 18th, 2014

Is it a Recall? Now what do we do?

Thursday, August 28, 2014
Noon – 5:30 pm   Read the rest of this entry »

July 30th, 2014

Process Validation: Proactive and Robust Validation Programs

ASQ Orange Empire Monthly Dinner Meeting – August 12, 2014 Read the rest of this entry »

July 23rd, 2014

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

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

Read the rest of this entry »

July 14th, 2014

Certified Manager of Quality & Organizational Excellence Prep / Refresher Course

When
Monday, July 28, 2014 6:00 PM  –  Monday, September 29, 2014 9:00 PM
Pacific Time Read the rest of this entry »

June 24th, 2014

BIOTECH PRIMER: CURRENT SCIENCE TRENDS, ISSUES, AND ADVANCES

June 30, 2014. 5:30 to 8:00 p.m. Read the rest of this entry »

June 10th, 2014

International Regulatory Science Symposium

June 19th, 2014

Read the rest of this entry »

May 9th, 2014

SABPA Bio-Pharma Conference 2014

Date:                     June 21, 2014, 8:00am – 4:50pm Read the rest of this entry »

May 7th, 2014

ASQ Orange Empire Monthly Dinner Meeting

Tuesday, May 13, 2014 5:15 PM – 9:00 PM Pacific Time Read the rest of this entry »

April 8th, 2014

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

Quality and Safety ConferenceWCC PR v2

March 27th, 2014

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

 

When:              Tuesday, April 8, 2014 Read the rest of this entry »

March 11th, 2014

Natural Products Expo West 2014
Food Expo West 2014

Read the rest of this entry »

March 10th, 2014

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

Wednesday, March 19, 2014

Read the rest of this entry »

March 10th, 2014

Leadership Strength – The Ultimate Competitive Advantage

Thursday, April 10, 2014 Read the rest of this entry »

March 10th, 2014

Knowing the best practices in applied statistics

uesday, March 11, 2014     5:30pm to 8:30pm

The Southern California Discussion Group of the ASQ Biomedical Division in association with ASQ SFV section 706 presents: Read the rest of this entry »

March 10th, 2014

ASQ March 2014 Roundtable – Risk Based Environmental Monitoring (EM)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 Read the rest of this entry »

March 5th, 2014

Discover the Secrets of Preparing Written Procedures that Work

ASQ Orange Empire Monthly Dinner Meeting – March 11, 2014 Read the rest of this entry »

March 5th, 2014

Success in Data Acquisition

 

ASQ Orange Empire Monthly Dinner Meeting – March 11, 2014 Read the rest of this entry »

February 26th, 2014

ASQ HDL Webinar: Facts Tell and Stories Sell

Webinar on February 26 Read the rest of this entry »

February 19th, 2014

Beer is Best

collage of photos from eventSCiftS and the Research Chef’s Association packed the Golden Road Brewing Company in Los Angeles to hear the world’s most knowledgeable beer researcher, Dr. Charlie Bamforth, a Distinguished Professor at UC Davis and the Anheuser-Busch Endowed Professor of Malting and Brewing Sciences talk about how beer is fun.

Here are a few interesting beer facts: Read the rest of this entry »

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