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

November 17th, 2014

11/19/14 @ 6::00 PM

Location:

  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.

Follow this link to Register

Register Here
or copy and cut this link:

http://www.cvent.com/d/n4qy4w

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!

 

 About 

Guneet Singh,

Sr. Director – Continuous Improvement, ADP – Added Value Services.

 

Guneet is a global business professional with continuous improvement experience managing
international strategic and functional units. He has designed and successfully launched continuous
improvement chapters in several companies in his professional carrier. Guneet has extensive work
experience in field of customer experience, continuous improvement in various industries across the
globe in companies like GE, Bank of America, SITEL & Stream Global services.
Abstract

In the present day competitive landscape across industries, a new philosophy, methodology, or approach
evolves daily, inspires market infatuation, and gains organizational embrace to finally deliver results
which vary substantially and are often questionable. The result is a never ending race to complete
certifications and knowledge badges in order to establish standards that demonstrate proficiency in an
ever growing number of new approaches. This is where continuous improvement or business process
innovation takes a different path.
It is not about a badge or certification or standard; it’s about a mindset, an approach, a philosophy – to
continuously strive for excellence by challenging the status quo.
Make it the way you think, live, & operate

 

Guneet will share the approach ADP takes and how and what tools they deploy in addition to how they handle change

Fundamentals of Data Quality

November 17th, 2014

Wednesday, November 19, 2014

at 6:30 PM

Fundamentals of Data Quality
By: Michael Scofield,
Assistant Professor of Health Information Management
at Loma Linda University

When you are managing the quality of any process, the quality of the data also becomes important.  The data you use for monitoring should accurately and fairly represent the physical reality.  But how do you know?

This presentation reviews the fundamental principles of data quality, including presence of data (when it should be present), validity, reasonable-ness, accuracy, precision, and consistency.  Each of these are separate characteristics, and we will look at numerous vivid examples of data problems at the row, column, and file level.

We will also discuss how poorly-defined business processes (where humans are involved in data capture or data entry) contribute to inaccurate data.   Some data errors are impossible to correct if they describe an event that is lost in history.  Better to improve the data capture process through user-friendly (and understandable) screen design and business process design.

Bio: Michael Scofield is an Assistant Professor of Health Information Management at Loma Linda University.  He is a popular speaker, writer, and consultant in the fields of data management, data quality assessment, and data visualization.

His career has included education and private industry in areas of data quality, decision-support systems, data warehousing, and data management.  His articles appear in DM Review, the B-Eye Newsletter, InformationWeek magazine, the Northern California Oracle User Group Journal, the IBI Systems Journal, and other professional journals.  He has spoken to over 240 professional audiences in these disciplines all over the U.S., in London, and Australia.  He also has a variety of topics for general audiences.  These topics include satellite imagery, the succession to the British monarchy, and various travel topics.  He also has humor published in the L.A. Times and other journals.

We will meet at the:

HomeTown Buffet

When you arrive announce that you are with ASQ.

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

Please Join Us!

Outsourcing 101

October 17th, 2014
You are Invited to the Joint Fall Conference 

Outsourcing 101

  

Sponsored by

San Diego Regulatory Affairs Network (SDRAN)

and 

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Wednesday, November 19, 2014 

 

Location:  Grand Pacific Palisades Resort & Hotel

5805 Armada Drive, Carlsbad, CA  92008

www.grandpacificpalisades.com 

 

Program Managers:

Amelia Cline, RAC, Regulatory Affairs Specialist, Peregrine Pharmaceuticals

Mugdha Dongre, Regulatory Affairs Specialist, Bausch and Lomb

Sybille Sauter, PhD, Associate Director, Halozyme Therapeutics, Inc.

 

Synopsis:

As more and more companies abandon the concept of creating products solely using their own internal resources, effective outsourcing has become a key success factor in drug and device development. Driven by an increasingly competitive commercial environment, products need to be produced faster, cheaper, and must be available to a global market. While cost reduction is still the primary goal behind most outsourcing, improved quality and a shorter time-to-market are two additional benefits of partnering with specialized vendors. The relationship between the client company and these vendors creates new opportunities and challenges. The question: How can you best establish and nurture this relationship?

 

The OCRA-SDRAN “Outsourcing 101″ conference offers insight into current outsourcing trends and shares advice on vendor selection and vendor management. Industry experts will address topics such as choosing the right partner, relationship governance, legal aspects, and ensuring the quality of products globally. Additional two parallel panel sessions will focus on Pharmaceuticals/Biologics and Devices/IVD. During these roundtables with vendor representatives, you will have the opportunity to pose questions to the panel and receive helpful suggestions from some of the most experienced professionals in the business. Make sure you don’t miss this opportunity to join your colleagues in beautiful Carlsbad, CA at the Grand Pacific Palisades, share your own expertise, and learn from some of the best in our field.

 

 

TIME ACTIVITY and SPEAKERS
7:30 – 8:15 Registration and Continental Breakfast
8:15 – 8:30 Opening Remarks: Regina O’Meara, OCRA President and IVD Regulatory Consultant
8:30 – 9:00 Keynote Speaker: tbd
9:00 – 9:45 Topic: Legal aspects of outsourcing

Speaker: Michael Swit, Special Council, FDA Law Practice, Duane Morris LLP

9:45 – 10:00 BREAK
10:00 – 10:50 Topic: Outsourcing for IVDs and Devices

Speaker: Natalie Kennel, President, NJK & Associates

11:00 – 11:50 Topic: Choosing the right toxicology CRO for your program

Speaker: Grace Furman, President/CEO, Paracelsus, Inc.

12:00 – 1:00 Lunch
1:00 – 1:30 Topic: Clinical trial conduct with CRO support

Speaker: tbd

1:35 – 2:05 Topic: Study data collection & verification

Speaker: Jamie Colgin, President, Colgin Consulting, Inc.

2:05 – 2:20 Introduction of panel sessions and chairs

Speaker: Regina O’Meara, OCRA President and IVD Regulatory Consultant

2:20 – 2:40 BREAK
2:40 – 4:10 Parallel Panel Sessions with Vendor Representatives: Discussion & Q&A

  • Drug/Biologics Panel (R. Lane, M. Paiz, chair: R. Hernandez)
  • IVD/Device Panel (A. Cotts, K. Kukulka, chair: N. Kennel)
4:15 – 4:30 Closing Remarks: SDRAN President-elect

 

Additional speakers and panelists to be added to the agenda. Periodic updates will be sent as new speakers are added. 

 

 

Cost: 

OCRA and SDRAN Members: $199

Government and Students: $100

Registration fee includes parking, breakfast, lunch, beverages and snacks. After the meeting, electronic access to the presentations will be made for all attendees. Dress code: Business casual 

  

 Click Here to Download the Event Flyer  

 

 

 

 

INSTRUCTIONS TO REGISTER ONLINE:

SDRAN Members:

Please register through SDRAN using this link:   http://www.sdran.org/

 

OCRA Members:

Step 1: 

Click on this link: http://www.ocra-dg.org/

 

Step 2:
Immediately log in with your username and password OR Create a new account by selecting “Register” on the top right hand side. If you are not an OCRA Member, it will ask you to join. Please keep in mind that to attend any OCRA meeting, we require you to become a Member. 

  

Step 3: 
Once you have logged on (and paid for membership) select the meeting you would like to attend and complete the registration process by filling in the appropriate fields.

NON MEMBERS

If you are not a Member of either organization, we do require you to join either OCRA or SDRAN before registering for this meeting. 

 

To join OCRA go to this link:   http://www.ocra-dg.org/

To join SDRAN, go to this link:  http://www.sdran.org/

 

PAYMENT OPTIONS To Pay With Credit Card 

Register and pay online as described above.  If you prefer to fax your registration form, please click on the form below to download it.  Complete the form and fax it with your credit card payment to: 949-266-8461

Click here to download the registration form


To Pay With Company or Personal Check
 

Please register online (see instructions above). Then select the “Pay Off-Line” payment method and select “Company Check” or “Personal Check”. Make sure to mail your check at least 10 days prior to the conference to ensure it is receive in time. Only paid attendees will be able to attend. If a check has not been received, you will be asked to provide a credit card as a hold until the check is received.

Mail your check payable to: 

Orange County Regulatory Affairs Discussion Group 

5319 University Dr., Suite 641, Irvine, CA 92612 

Tel:      949-387-9046 

Fax:     949-266-8461 or 949-387-9047 

Email:  ksyre@cox.net 

OCRA’s non-profit Federal Tax ID# 33-0630455 


To Pay using PayPal

When registering online PayPal is one of the payment options.

PayPal requires that you set up an account with them prior to making payment for this meeting. Once you receive confirmation of your new account, then you can register for this meeting.

RECEIPTS FOR PAYMENT
Please use the online payment process for an immediate receipt.

Name badges and materials will be provided at the on-site registration desk.

Registration Fee includes the following: Electronic access to available presentations, continental breakfast, lunch and parking.

Cancellations
Sorry, no cancellations available for this meeting.

DRIVING DIRECTIONS:

Grand Pacific Palisades Resort & Hotel

5805 Armada Dr, Carlsbad, CA 92008
Reservations (800) 725-4723

Front Desk (760) 827-3200

 

From San Diego:

Take I-5 North to Palomar Airport Road in Carlsbad and turn Right.

Turn Left on Armada Drive and then Left again into Grand Pacific Palisades Resort & Hotel.

 

 

From Orange County or Los Angeles:

Take I-5 South to Palomar Airport Road in Carlsbad and turn Left.

Turn Left on Armada Drive and then Left again into Grand Pacific Palisades Resort & Hotel.

 

 

We recommend you look up driving directions from your own starting point.

 


Regulatory Inspections and How to Manage Them

October 17th, 2014

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 

 

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 Speaker:

Gustavo Kobrin, President Strategic Regulatory Solutions, Inc.

Panelists: 

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

Trudy R, Papson, Principal Consultant, Regulatory Consultants Group and Former FDA Investigator

Deborah Madsen, PE, Madsen Quality and Regulatory Consulting and Former Notified Body Auditor

Purpose: 

This program is intended to provide information on regulatory inspection types and how to manage them.
Synopsis: 

Regulatory agencies, such as the FDA, Notified Bodies and Registrars inspect industry to ensure conformity of your practices for the purpose of establishing compliance to applicable regulations. Regulated companies are inspected on a routine basis both domestically and on the international level. Some inspections are considered “for cause” if there are circumstances which require an unannounced inspection.

 

A company’s goal is to effectively manage an inspection and to reduce the impact on the company’s operations. The goal of the regulator is to ensure public health and safety. They are concerned with enforcing and obtaining voluntary compliance with laws and regulations, protecting consumers from products that are impure, harmful, ineffective, improperly labeled, or in some other way dangerous, defective or deceptive.

 

Please join us in an informative and practical forum as we discuss how to manage an inspection, FDA-483s, Warning Letters and Notified Body Reports. We will also cover NCR best practices and how to manage them. Hear from an expert panel in regard to true war stories and how they were managed and resolved.

 

 

REGISTRATION DEADLINE: October 31, 2014

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.

 

Agenda:

5:30 pm Registration, Networking and Dinner

6:00 pm Program Opening

6:05 pm Inspection Processes, Preparation and Management

6:30 pm Managing resolution of inspection findings and other post-audit activities

7:00 pm Break

7:10 pm Case Studies and Panel Discussion

8:30 pm Q&A

9:00 pm Adjourn


Speaker/Panelist Bios:  

Gustavo “Gus” Kobrin, President of Strategic Regulatory Solutions, Inc. (SRS)

Gustavo Kobrin has been a quality assurance and regulatory compliance consultant since 1998. His company, Strategic Regulatory Solutions, Inc., specializes in international and domestic regulatory affairs, regulatory compliance including product registrations, regulatory inspection management, quality system development, auditing, and project management.

Gus is a Notified Body Auditor (ISO9001:08, EN ISO13485:12, CMDCAS and MDD (93/42/EC)), Certified Quality Auditor (CQA) and Certified Regulatory Affairs professional (RAC) with more than 35 years of experience in the medical device industry. Mr. Kobrin has assisted numerous medical device companies, from the very small to multi-national corporations. He is a long time member of ASQ and RAPS. He has served on the OCRA Program Committee and on its Board of Directors. Kobrin holds a Bachelor of Science degree from the University of California, Irvine.


Deborah Madsen, PE, Quality Systems and Regulatory Compliance Consultant 

Deborah has been working in the medical device and in-vitro diagnostic industries for over 28 years. Deborah as held several roles at UL (a Notified Body) including regional lead reviewer, lead auditor, instructor/trainer, auditor qualifier, technical support for medical regulatory sales, and technical file assessor. She served as regional lead reviewer with responsibility for reviewing audits performed by other staff members and making certification decisions as well as determining whether companies were eligible for registration. She conducted audits as lead auditor in accordance with ISO 9001, ISO 13485, implementation of HC CMDR requirements under CMDCAS program, Medical Device Directive (93/42/EC), In Vitro Diagnostic Directive (98/79/EC), ISO 14971, and IEC 62304.

 

Prior to her work at UL, she spent eight years at a leading manufacturer of in vitro diagnostic and laboratory equipment, where she was responsible for worldwide product safety, EMC compliance, quality systems and regulatory compliance. Deborah also served as standards developer, U.S. technical expert, and member of IEC TC66 (laboratory equipment, IEC 61010-1) and contributed to development and revision of IEC 61010-1. Served as convener for IEC TC66 WG10 (centrifuges) and TC 66 WG11 (in vitro diagnostic equipment). Led development and issuance of IEC 61010-2-020, IEC 61010-2-089, and IEC 61010-2-101.

Deborah holds a degree in electrical engineering from the University of Illinois – Urbana and is a Registered Professional Engineer.

T.R. “Trudy” Papson, Principal Consultant, Regulatory Consultants Group

Trudy Papson is co-founder of Regulatory Consultants Group (RCG) and former FDA Investigator with the U.S. FDA, Los Angeles District Office.In her career at the FDA, she conducted hundreds of high profile, compliance follow-up and for-cause medical device inspections. Her experience also includes conducting pre-approval inspections, medical device pre-market/post-market approval inspections and BIMO inspections of clinical investigators and sponsor/monitors.

 

She received the Department of Health Services highest awards as a Medical Device Investigator. As Recall Coordinator she oversaw and worked with industry on serious public health threats and related problems with international significance. Papson is the recipient of numerous awards by the FDA for service and excellence.

 

Kim Walker, MS, RAC (US & EU)

Kim Walker, MS, RAC is an independent Global Regulatory Affairs and Quality Assurance Consultant and an owner of Kim Walker Consulting since 2006. In her consulting practice, she assists clients with pre- and post-market regulatory and quality system needs. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory science, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, start-up company, and large company environments.

Kim has served on the Orange County Regulatory Affairs Discussion Group (OCRA) Program Committee since 2003. Additionally, she served on the OCRA Board of Directors 2004-2010 and was the 2008-2009 President. Kim participated on the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups and was listed as one of the authors for CLSI GP22-A3. Quality Management System: Continual Improvement. She has managed, presented at and/or moderated at several professional conferences and educational institutions on clinical, regulatory, and quality topics. She also has participated in the SDRAN Mentoring Program since 2009. Kim participated on the CSUPERB Advisory Committee and Development Team for the Project Management in Clinical Trials certificate program through the California State University system. She was the instructor for the “Pre-Market Submission” course and co-instructor for the “Regulatory Requirements for Medical Products” course in the certificate program. Kim was also an instructor for the “Regulatory Requirements for Pharmaceutical Products” course and a co-instructor for the “Technical Writing for the Medical Product Industry” course at the University of California Irvine Extension. She achieved both the US and EU RAPS Regulatory Affairs Certifications. Kim received the 2008 Leonard Stauffer Award from RAPS in recognition of her contributions to mentoring and furthering regulatory professional education development.

She graduated from Auburn University with a Bachelor of Science degree in Bio-Medical Sciences and graduated with a Master of Science degree in Regulatory Affairs from San Diego State University.

 

 

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 any approved presentations will be made for all attendees.  

 

Dress code is business casual.

  

  

Click Here to Download the Event Flyer

Precision Medicine: A Medical Miracle or Ethical Nightmare?

October 17th, 2014

Date(s):                Nov 6 2014, 05:00 PM to 07:00 PM

Location:               CareFusion Corporation

REGISTER NOW!

During this presentation you 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.

Speaker
Agenda
Contact
Travel Information

 

Cancellation Policy

The Reproducibility Crisis in Biomedical Research

October 17th, 2014

 

The Reproducibility Crisis in Biomedical Research

An ASQ Los Angeles Section and FD&C Division Joint Event

 

Wednesday, October 29, 2014
5:30 p.m. at Phenomenex
2341 West 205th Street, Torrance, CA 90501

 

SEATS ARE LIMITED, SO REGISTER NOW. FIRST COME, FIRST SERVE.

New quality practices developed by the ASQ FD&C Division could change the trend in the reproductibility crisis in biomedical research!

“The productivity of modern drug development has been steadily declining over the last two decades. The total spend on biomedical research has reached about $270 million globally, but the number of new drugs relative to this investment has been going down steadily. There are many reasons for the declining output of drug development, but one of the main reasons is the lack of reproducibility of biomedical research in general. Some people even claim that the majority of biomedical studies cannot be reproduced. There is now mounting evidence that general quality problems are a root cause for this issue. Indeed, there is no commonly accepted quality standard for biomedical research. A working group of the ASQ FD&C has therefore developed new guidelines for “Best quality practices for biomedical research in drug development” which will be discussed in this session.”

Ülo Palm, MD, PhD, MBA, is currently Senior Vice President Branded Drug Development Operations with Actavis Pharmaceuticals. Prior to Actavis, he was the SVP Clinical Operations & Biometrics and Therapeutic Area Head Respiratory Clinical Development with Forest Labs. Before joining Forest, Dr. Palm held the positions of Global Head Laboratory & Preclinical Quality Assurance and Global Head Clinical Operations Oncology with Novartis Pharmaceuticals. Prior to Novartis, Dr. Palm worked with Schering-Plough and Bayer in different operational and medical drug development functions. He has a total of 25 years of experience in the pharmaceutical industry. Dr. Palm is Senior Member of the American Society for Quality (ASQ), he is certified as a Manager of Quality and Organizational Excellence (CMQ/OE). He serves on the Board of Directors of ANAB, the ANSI-ASQ National Accreditation Board. He is also a member of the TransCelerate BioPharma Operations Committee and chair of the Future Initiatives sub-committee, investigating new project opportunities for TransCelerate to improve the efficiency of clinical research.

 

REGISTER NOW AT http://www.eventbrite.com/e/the-reproducibility-crisis-in-biomedical-research-tickets-13557002359

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

October 17th, 2014

 

Location
Date and Time
Overview
Description


Speaker


Agenda


Contact


Travel Information


Cancellation Policy
Price: Online – Pre-Registration (Sep 30, 2014 – Oct 23, 2014)
 Registrant Type Price
Member
US$ 20.00
Non-Member
US$ 25.00

Supplier Quality Management: A Risk Based Approach

October 14th, 2014

This month’s Section 706 event will take place on Wed, October 22, 2014

Topic: Supplier Quality Management: A Risk Based Approach

Speaker: Gopal Mohanty Ph.D

Supply chain networks used by companies are expanding and evolving at an unprecedented pace. Companies are experiencing enormous pressure to improve supply chain efficiency, reduce costs, and improve product quality while maintaining compliance with organizational policies, and applicable regulatory standards. A risk based approach will be presented on how to manage supplier quality and ensure that the quality of receiving items meet the requirements.

Speaker Bio: Gopal Mohanty has 20+ years of experience in driving efficiency in Quality Systems to improve pre and post market product quality. Gopal holds a PhD in Industrial Engineering, and an ASQ Certified Auditor, Quality Manager, Quality Engineer, Reliability Engineer, and Six Sigma Black belt.

ASQ Members: $25.00. Non-ASQ attendees: $35.00.
Dinner (Buffet)

Please send email to Prasad Mushti at pmushti@yahoo.com to register for this event.

Walk ins up to 5 persons allowed for presentation only at 6:45 pm

Agenda
5:30 to 6:00 PM Sign In / Networking
6:00 to 6:45 PM Dinner
6:45 to 7:45 PM Presentation
7:45 to 8:00 PM Announcements/Door Prizes

Location:
Marie Callendar’s Restaurant
1310 Business Center Dr.
Northridge, CA 91324.

Regulatory Inspections and How to Manage Them

October 13th, 2014
Wednesday, November 5, 2014 

5:30 – 9:00 pm 

 

 

Location:   

Abbott Medical Optics Inc. (AMO) 

1700 E. Saint Andrew Place, Santa Ana, CA  92705-4933  

 

Program Host: 

Tammy Vu, Sr. Regulatory Affairs Specialist, Global RA
Abbott Medical Optics Inc.  

 

Program Manager and Speaker:

Gustavo Kobrin, President Strategic Regulatory Solutions, Inc.

Panelists: 

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

Trudy R, Papson, Principal Consultant, Regulatory Consultants Group and Former FDA Investigator

Deborah Madsen, PE, Madsen Quality and Regulatory Consulting and Former Notified Body Auditor

Purpose: 

This program is intended to provide information on regulatory inspection types and how to manage them.
Synopsis: 

Regulatory agencies, such as the FDA, Notified Bodies and Registrars inspect industry to ensure conformity of your practices for the purpose of establishing compliance to applicable regulations. Regulated companies are inspected on a routine basis both domestically and on the international level. Some inspections are considered “for cause” if there are circumstances which require an unannounced inspection.

 

A company’s goal is to effectively manage an inspection and to reduce the impact on the company’s operations. The goal of the regulator is to ensure public health and safety. They are concerned with enforcing and obtaining voluntary compliance with laws and regulations, protecting consumers from products that are impure, harmful, ineffective, improperly labeled, or in some other way dangerous, defective or deceptive.

 

Please join us in an informative and practical forum as we discuss how to manage an inspection, FDA-483s, Warning Letters and Notified Body Reports. We will also cover NCR best practices and how to manage them. Hear from an expert panel in regard to true war stories and how they were managed and resolved.

 

 

Agenda:

5:30 pm Registration, Networking and Dinner

6:00 pm Program Opening

6:05 pm Inspection Processes, Preparation and Management

6:30 pm Managing resolution of inspection findings and other post-audit activities

7:00 pm Break

7:10 pm Case Studies and Panel Discussion

8:30 pm Q&A

9:00 pm Adjourn

 


Speaker/Panelist Bios:  

Gustavo “Gus” Kobrin, President of Strategic Regulatory Solutions, Inc. (SRS)

Gustavo Kobrin has been a quality assurance and regulatory compliance consultant since 1998. His company, Strategic Regulatory Solutions, Inc., specializes in international and domestic regulatory affairs, regulatory compliance including product registrations, regulatory inspection management, quality system development, auditing, and project management.

Gus is a Notified Body Auditor (ISO9001:08, EN ISO13485:12, CMDCAS and MDD (93/42/EC)), Certified Quality Auditor (CQA) and Certified Regulatory Affairs professional (RAC) with more than 35 years of experience in the medical device industry. Mr. Kobrin has assisted numerous medical device companies, from the very small to multi-national corporations. He is a long time member of ASQ and RAPS. He has served on the OCRA Program Committee and on its Board of Directors. Kobrin holds a Bachelor of Science degree from the University of California, Irvine.


Deborah Madsen, PE, Quality Systems and Regulatory Compliance Consultant 

Deborah has been working in the medical device and in-vitro diagnostic industries for over 28 years. Deborah as held several roles at UL (a Notified Body) including regional lead reviewer, lead auditor, instructor/trainer, auditor qualifier, technical support for medical regulatory sales, and technical file assessor. She served as regional lead reviewer with responsibility for reviewing audits performed by other staff members and making certification decisions as well as determining whether companies were eligible for registration. She conducted audits as lead auditor in accordance with ISO 9001, ISO 13485, implementation of HC CMDR requirements under CMDCAS program, Medical Device Directive (93/42/EC), In Vitro Diagnostic Directive (98/79/EC), ISO 14971, and IEC 62304.

 

Prior to her work at UL, she spent eight years at a leading manufacturer of in vitro diagnostic and laboratory equipment, where she was responsible for worldwide product safety, EMC compliance, quality systems and regulatory compliance. Deborah also served as standards developer, U.S. technical expert, and member of IEC TC66 (laboratory equipment, IEC 61010-1) and contributed to development and revision of IEC 61010-1. Served as convener for IEC TC66 WG10 (centrifuges) and TC 66 WG11 (in vitro diagnostic equipment). Led development and issuance of IEC 61010-2-020, IEC 61010-2-089, and IEC 61010-2-101.

Deborah holds a degree in electrical engineering from the University of Illinois – Urbana and is a Registered Professional Engineer.

T.R. “Trudy” Papson, Principal Consultant, Regulatory Consultants Group

Trudy Papson is co-founder of Regulatory Consultants Group (RCG) and former FDA Investigator with the U.S. FDA, Los Angeles District Office.In her career at the FDA, she conducted hundreds of high profile, compliance follow-up and for-cause medical device inspections. Her experience also includes conducting pre-approval inspections, medical device pre-market/post-market approval inspections and BIMO inspections of clinical investigators and sponsor/monitors.

 

She received the Department of Health Services highest awards as a Medical Device Investigator. As Recall Coordinator she oversaw and worked with industry on serious public health threats and related problems with international significance. Papson is the recipient of numerous awards by the FDA for service and excellence.

 

Kim Walker, MS, RAC (US & EU)

Kim Walker, MS, RAC is an independent Global Regulatory Affairs and Quality Assurance Consultant and an owner of Kim Walker Consulting since 2006. In her consulting practice, she assists clients with pre- and post-market regulatory and quality system needs. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory science, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, start-up company, and large company environments.

Kim has served on the Orange County Regulatory Affairs Discussion Group (OCRA) Program Committee since 2003. Additionally, she served on the OCRA Board of Directors 2004-2010 and was the 2008-2009 President. Kim participated on the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups and was listed as one of the authors for CLSI GP22-A3. Quality Management System: Continual Improvement. She has managed, presented at and/or moderated at several professional conferences and educational institutions on clinical, regulatory, and quality topics. She also has participated in the SDRAN Mentoring Program since 2009. Kim participated on the CSUPERB Advisory Committee and Development Team for the Project Management in Clinical Trials certificate program through the California State University system. She was the instructor for the “Pre-Market Submission” course and co-instructor for the “Regulatory Requirements for Medical Products” course in the certificate program. Kim was also an instructor for the “Regulatory Requirements for Pharmaceutical Products” course and a co-instructor for the “Technical Writing for the Medical Product Industry” course at the University of California Irvine Extension. She achieved both the US and EU RAPS Regulatory Affairs Certifications. Kim received the 2008 Leonard Stauffer Award from RAPS in recognition of her contributions to mentoring and furthering regulatory professional education development.

She graduated from Auburn University with a Bachelor of Science degree in Bio-Medical Sciences and graduated with a Master of Science degree in Regulatory Affairs from San Diego State University.

 

 

Cost:

OCRA Members: $50

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

Government and Students: $25

FREE for AMO Employees (please email Tammy to be added to the list)

 

 

Registration fee includes light dinner, beverages and parking.

 

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

 

Dress code is business casual.

  

  

Click Here to Download the Event Flyer

 

 

 

Regulatory Inspections
and How to Manage Them   

 

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Wednesday, November 5, 2014 

5:30 – 9:00 pm 

 

REGISTRATION INFORMATION 

For an Immediate Receipt, Please Use the On-Line or PayPal Option 

http://www.ocra-dg.org/

REGISTRATION RATE  

$50    OCRA Members

$100    Non-members (includes OCRA membership for one year)   

$25      FDA/Government/Students*
FREE for AMO Employees – please email Tammy to be added to the list 

 

* Student Rate is for individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. The Student Rate does not apply to working professionals taking one or two courses on the side.  Student ID and copy of current class schedule are required to register at this rate. Final eligibility determined by OCRA.

INSTRUCTIONS TO REGISTER ONLINE:

Log onto the OCRA website (http://www.ocra-dg.org/) with your username and password OR Create a new account by selecting “Register” on the top right hand side. If you are not an OCRA Member, it will ask you to join. Please keep in mind that to attend any OCRA meeting, we require you to become a Member. 

  

Once you have logged on (and paid for membership), click on “Register for a Meeting”. All of OCRA’s active meetings will be listed. Select the meeting you would like to attend and complete the registration process by filling in the appropriate fields.

PAYMENT OPTIONS To Pay With Credit Card 

Register and pay online as described above or use this form to register and fax it with your credit card payment to: 949-266-8461

Group Registrations
When registering online, please register each person individually.  Faxed registrations will also be accepted. Please complete the entire registration form for each person attending.

 Click here to download the registration form 


To Pay With Company or Personal Check
 

Please register online and select the “Pay Off-Line” payment method and select “Company Check” or “Personal Check”. Make sure to mail your check at least 10 days prior to the conference to ensure it is receive in time. Only paid attendees will be able to attend. If a check has not been received, you will be asked to provide a credit card as a hold until the check is received.

Mail your check payable to: 

Orange County Regulatory Affairs Discussion Group 

5319 University Dr., Suite 641, Irvine, CA 92612 

Tel:      949-387-9046 

Fax:     949-266-8461 or 949-387-9047 

Email:  ksyre@cox.net 

OCRA’s non-profit Federal Tax ID# 33-0630455 


To Pay using PayPal

When registering online PayPal is one of the payment options.

Cancellation Deadline:

For a refund, please reply to this email by October 29, 2014 to request a refund.

 

NOTE: We will ask for a credit card payment for any checks not received by the meeting date.

 

If you have reserved a space but do not attend, your payment MUST be remitted.

 

 

DRIVING DIRECTIONS:

Abbott Medical Optics (AMO)
1700 E. St. Andrew Place
Santa Ana, CA 92705
(714) 247-8200

Directions to AMO from Los Angeles International Airport:
– Exit the airport and follow the signs to 405 south (Long Beach)
– Continue on 405 for approximately 35 miles
– Take the 55 north and exit at Edinger Avenue
– Turn left onto Edinger
– Turn left on Lyon Street
– Turn left on St. Andrew Place and enter the first driveway on the right.

Directions to AMO from John Wayne, Orange County Airport:
– On exiting the airport, turn left onto MacArthur Boulevard
– Take the 55 north and exit at Edinger Avenue
– Turn left onto Edinger
– Turn left on Lyon Street
– Turn left on St. Andrew Place and enter the first driveway on the right.

 

We recommend you look up driving directions from your own starting point.

 

  

Kimberly Syre

Attention To Detail
5319 University Dr., Suite 641
Irvine, CA  92612
Tel:    949-387-9046
Fax:    949-387-9047
Alt Fax:    949-266-8461
Email:    ksyre@cox.net

If you do not wish to receive future promotional e-mails from our organization, reply to this e-mail with the name of the organization, followed by REMOVE in the subject line.  Please reply to this exact email or include the group name so we are aware of which organization you are referring to. 

8D (Eight Disciplines) Problem Solving

October 13th, 2014

Wednesday, October 15, 2014

at 6:30 PM

8D (Eight Disciplines) Problem Solving
By:
Jack B. ReVelle, Ph.D

8D (Eight Disciplines) Problem Solving is a method used to approach and resolve problems which is typically employed by quality engineers or other professionals.  Its purpose is to identify, correct and eliminate recurring problems, and is useful in product and process improvement.  It establishes a permanent corrective action based on statistical analysis of the problem (when appropriate) and focuses on the origin of the problem by determining its root causes.  Although it originally comprised eight stages, or ‘disciplines’, it was later augmented by an initial planning stage.  The 8D follows the logic of the Plan, Do, Check, Act (PDCA) cycle.

Bio: Dr. Jack B. ReVelle provides his advice and assistance as a consulting statistician.  His credentials include over 40 clients and over 30 books, handbooks, videos and software packages.  Dr. ReVelle received his B.S. in Chemical Engineering from Purdue University, and both his M.S. and Ph.D. in Industrial Engineering and Management from Oklahoma State University.  Prior to earning his Ph.D., he served 12 years in the U.S. Air Force.  During that time, he was promoted to the rank of major and was awarded the Bronze Star Medal while stationed in the Republic of Vietnam as well as the Joint Service Commendation Medal for his work in quality assurance with the Defense Atomic Support Agency in the Pentagon.  He has been elected as a Fellow by theAmerican Society for Quality, the Institute of Industrial Engineers, and the Institute for the Advancement of Engineering.  Dr. ReVelle was awarded the Dorian Shainin Medal by the American Society for Quality (ASQ) in May 2012.

We will meet at the:

HomeTown Buffet
390 McKinley Avenue
Corona Hills Plaza
Corona, CA 92879

Dinner: $13.25 / pp

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

When you arrive announce that you are with ASQ.

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

Please Join Us!