Risk Based Auditing and Fun-damentals

April 8th, 2015
You are Invited to an Evening Meeting

 

Risk-Based Auditing

and Fun-damentals

    

Orange County Regulatory Affairs Discussion Group

 

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

 

Auditing is a part of life, almost irrespective of the industry.

We can make it as hard as we want, trading efficiency and effectiveness for a check box in the done column.

This program will provide an overview to a risk-based approach to the audit process plus an auditing process overview.

Location:   

Alcon Laboratories, Inc. – New Venue

15800 Alton Parkway
Irvine, California 92618

 

Program Manager and Speaker:  

James R. Lusk, Principal, Quality Systems International

About the Speaker

James (Rusty) Lusk has over 37 years of experience in regulated and non-regulated industries ranging from early-stage development to Fortune 100 companies. He has held senior management positions in disciplines such as Regulatory, Quality, Clinical Programs, and New Business Development. He is currently a Principal with Quality Systems International; a multidiscipline consulting company serving ISO/EN and FDA regulated industries. He is also co-founder of LifePulse, LLC, an early-stage medical device company and co-inventor of a non-invasive device intended to delay or reverse cardiovascular disease and improve quality of life.

 

He is Past President of Orange County Regulatory Affairs (OCRA) Discussion Group, a nonprofit organization with the mission of educating the regulatory professionals.

 

He has an MBA from Pepperdine University, a BS in Biological Sciences from The University of California, Irvine and an AA in Electronics from Orange Coast College.

 

He is has the following certifications: Regulatory Affairs Professional (RAC both US & EU), American Society for Quality: CMQ/OE, CQE, CQA, CQAHACCP and Lead Auditor, Quality Management Systems, RABQSA.

 

Schedule:

4:00 – 5:00 pm

Registration, Networking and Appetizers

 

5:00 – 7:00 pm

Presentation and Q&A

 

 

Cost:

OCRA Members: $50

Non Members: $100

*Students and Government: $25

     

 Click Here to Download the Event Flyer 

 

 

 

REGISTRATION INFORMATION 

Online Registration Instructions:

Step 1:   

Click on this link:

https://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.

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.

The Student Rate is for individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. This rate is not available for online registration. The Student Rate does not apply to working professionals taking one or two courses on the side. To qualify, please fax your registration form with student ID and copy of current class schedule to 949-266-8461. Final eligibility determined by OCRA.

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.

Cancellations For a refund, please email your cancellation request to Rob Fleming (rob.fleming@yahoo.com) by April 14, 2015.

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       

Alcon Laboratories 

15800 Alton Pkwy 

Irvine CA 92618

 

 

Directions from LA:

Take I-405 S to Exit 3 (in Irvine).

Take ramp right and follow signs for Shady Cyn Dr/Sand Cyn Ave.

Turn left onto Sand Canyon Ave.

Turn right onto Alton Pkwy.

Go 0.9 miles and arrive at 15800 Alton Pkwy, Irvine.

The last intersection is Telemetry.

(If you reach Banting, you’ve gone too far.)

 

Directions from San Diego:

Take I-5 N to Exit 94B.

Take ramp right and look for signs for Alton Pkwy.

Turn left onto Alton Pkwy.

Make a u-turn at Telemetry and arrive 15800 Alton Pkwy.

(If you reach Banting, you’ve gone too far.)

 

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

ASQ Northeast Conference 2015

March 4th, 2015

The FD&C Division and Princeton Section present…

 ASQ Northeast Conference 2015

Friday, April 10, 2015

7:30 a.m. – 5:00 p.m.

410 George Street, New Brunswick, NJ 08901

Are you ready to take the CPGP or CHA Certification Exam, but need a quick refresher course? Come join us at the ASQ Northeast Conference to take an intensive one-day review of the BOK and ask questions from certified professional(s).  Your trainer(s) will prepare you to sit for and pass the exam and help guide you through the test taking process.

Track A: CPGP Refresher Workshop

OR

Track B: CHA Refresher Workshop

ASQ Member $160 (+Eventbrite fee)

Non-ASQ Member $185 (+Eventbrite fee)

Lunch and refreshments are included with your registration. Seating is limited to 30 people, so please register now at http://asqneconference2015.eventbrite.com

Upon completing your registration to attend the conference, you will receive a special 30% off discount on a CPGP/CHA handbook and/or book of questions. Please take advantage of this special offer to help  you pass your exam.

Conference attendees also have the opportunity to take the certification examination for CPGP and CHA on Saturday, April 11, 2015 at 8:00 a.m. Attendees who wish to take the CPGP or CHA examination must complete the Examination Application Form and submit it with supporting documents and credit card payment to Mary Martin at mmartin@asq.org no later than March 26, 2015.  Take advantage of this special NE Conference discount rate of $219.00 (regularly priced at $269/$419)!

REGISTER NOW!

FIBR: Meet Your Inspectors Forum

March 2nd, 2015

Wednesday, May 20, 2015

Embassy Suites (8425 Firestone Blvd., Downey, CA 90241)

8:00am Registration and Breakfast

9:00am Forum

  • Semonella Stanely Outbreak, State of California Department of Public Health
  • Did You Know?, CalOsha
  • FDA Food Safety Updates, FDA
  • Interactive Exercise with Local County Inspectors, Southern California Health Department
  • Allergens & Recalls and Safety Services (FSIS), USDA
  • Ask your Inspectors Panel

4:30pm Adjourn

For more information, go to http://fibr.info/programs/meet-your-inspectors/2015/index.html

Register now!

FIBR Networking Dinner

February 2nd, 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.

Empress Pavilion Restaurant
988 N. Hill Street
(located in the Bamboo Plaza-China Town)
Los Angeles, California 90012
TEL: (213) 617-9898

Click here for map and directions

Cost

FIBR, United AG, Sabor Latino, FCG,
Ca.Agribusiness CU, Vernon Chamber Commerce Members:
$35
Students: $25
Non-Members: $45

Cash or Check or online via PayPal

Payment

PAY ONLINE:

Registration fee can be paid online via PayPal. Click here to pay and register online.

Pay by Check

If you prefer to pay by check, please make check payable to FIBR and mail to:
FIBR, 520 W. 23rd Street, L.A., CA 90007

Registration

IMPORTANT: Must RVSP online using the form below. Click here to pay and register online.

As This is a Food-included Event, Reservations are Considered Guaranteed.

Additional information: Email, Helene Martinez: hmartinez@fibr.info

2015 Southern California Food Industry Conference

January 8th, 2015

Button Up for the Winds of Change 

Labels, Regulations, and Consumer Expectations

 

Wednesday March 4, 2015 9am – 3pm

Marriott Anaheim Convention Center

 

Come find out what’s on the horizon then head into Supplier’s Night at the same location

 

Consumer Perspectives Driving Nutritional and Regulatory Changes

Dr. Christine Bruhn, Director, Center for Consumer Research, Food Science & Technology, UC Davis

 

Regulatory challenges in the emerging food segment of cannabis edibles

Lisa Lupo, Editor, Quality Assurance and Food Safety Magazine

 

Background and impact of proposed changes to nutrition labels and serving sizes 

Martin Hahn, Lawyer and Partner at Hogan Lovells, Washington DC 

 

Insects as food, changing attitudes of the westernized “yuck” factor 

Dr. Florence Dunkel, Associate Professor, Montana State University

 

Food industry labeling outlook

Dr. Janet Collins, IFT Past President and Senior Manager, Regulatory Affairs, Dupont Company

 

Impact of the Food Safety Modernization ACT (FSMA) on the Food Industry

Stephanie Barnes, Regulatory Counsel, Food Marketing Institute

 

Continuing education credits applied for with IFT, AND, and ASQ

 

Registration: 

Student, Full Day: $45.00

Student, Half Day: $25.00

Non-Student, Full Day $95.00

Non-Student, Half Day: $50.00

 

Click her to register http://www.scifts.net/scfic.html

SCFIC 2015 promo flyer 2015-0107

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