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

August 18th, 2014

You are Invited to an Evening Meeting

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

 

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

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Wednesday, September 10, 2014

5:30 – 8:45 pm 

Location:   

HORIBA Medical 

9755 Research Drive, Irvine, CA  92618

Program Host: 

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

 

Program Manager and Moderator:

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

Presenters: 

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

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

Barb Stevens, RAC, Regulatory Consultant

Synopsis: 

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

 

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

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

 

 

REGISTRATION DEADLINE:  September 5th

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

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

 

 

Schedule of Presentations:

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

 

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

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

 

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

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

 

7:30 – 8:15 pm             

510(k) FDA Review Process and Submission Best Practices

Barb Stevens, RAC, Regulatory Consultant

 

8:15 – 8:45 pm                         

Panel Discussion, Speaker Q&A, and Closing Remarks

 

Cost:

OCRA Members: $50

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

Government and Students: $25

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

 

 

Registration fee includes light dinner, beverages and parking.

 

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

 

Dress code is business casual.

 

  

Click Here to Download the Event Flyer

Is it a Recall? Now what do we do?

August 18th, 2014

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

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

Location:   

Irvine Marriott

18000 Von Karman

Irvine, CA  92612

949-553-0100  

 

Program Managers:

Mugdha Dongre, Regulatory Affairs Specialist, Bausch + Lomb

James (Rusty) Lusk, Principal, Quality Systems International

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

 

Speakers:

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

James (Rusty) Lusk, Principal, Quality Systems International

Denise McEachern, Consultant

Thanh Tran, District Recall Coordinator, FDA Los Angeles District

  

Synopsis:

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

 

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

 

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

 

    

 

 

Agenda:

Noon – 12:45 pm

Registration, Networking and Light Buffet Lunch

 

12:45 – 1:30 pm

Identifying and Strategizing Recalls

James (Rusty) Lusk, Principal, Quality Systems International

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

 

1:30 – 2:15 pm

FDA Requirements

Thanh Tran, District Recall Coordinator, FDA Los Angeles District

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

 

2:15 – 2:30 pm

Ice Cream Break

 

2:30 – 3:10 pm

Execution of a Recall

Denise McEachern, Consultant

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

 

3:10 – 3:50 pm

Post Market Surveillance to prevent Recall

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

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

 

3:50 – 4:05 pm

Break

 

4:05 – 5:00 pm

Case Study and Q&A

 

5:00 – 5:20 pm

Networking 

 

 

Cost:

OCRA Members: $155

Non Members: $205

Government and Students: $75

 

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

  

 Click Here to Download the Event Flyer   

Process Validation: Proactive and Robust Validation Programs

July 30th, 2014

ASQ Orange Empire Monthly Dinner Meeting – August 12, 2014

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

PRESENTATIONS

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

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

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

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

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

Register

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

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

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

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

View Event Summary

View Event Agenda

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

July 23rd, 2014

ASQ Orange Empire Quarterly Breakfast Meeting

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

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

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

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

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

Register

Oncology Research Nurses, Los Angeles

July 22nd, 2014

Oncology Research Nurses (Contract/Perm)

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

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

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

Contact:

Jan Clements

(818) 552-2105

jclements@meirxrs.com

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

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

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

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

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

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View Event Agenda
Thursday, July 24, 2014

Register

Certified Manager of Quality & Organizational Excellence Prep / Refresher Course

July 14th, 2014
Certified Manager of Quality & Organizational Excellence Prep / Refresher Course

SESSIONS/DATES
9 sessions; Mondays from July 28, 2014 to September 29, 2104. No class on Labor Day, September 1, 2014.

Will cover: Leadership, Strategy Development & Deployment, Quality Management Tools, Customer Focused Organizations, Supplier Performance, Management, & Training/Development. Plus, strategies/tips for preparing & taking the exam.

When
Monday, July 28, 2014 6:00 PM  -  Monday, September 29, 2014 9:00 PM
Pacific Time

Location
Alcon Laboratories
15800 Alton Parkway, Irvine, California 92618 USA

Fee
Course Registration
Employed Member Fee $350.00 for a limited time  ($400.00 original price)
Nonmember Fee $500.00 for a limited time  ($550.00 original price)
Unemployed Member Fee $200.00

View Event Summary

Having trouble with the link? Simply copy and paste the entire address listed below into your web browser:
http://www.cvent.com/d/whtS34MP2EuuYAqEnprwiQ/97vm/P1/1Q?

 

BIOTECH PRIMER: CURRENT SCIENCE TRENDS, ISSUES, AND ADVANCES

June 24th, 2014

REGISTER BY WEDNESDAY JUNE 25 FOR $25.  Rate goes up to $30 on June 26.

 

San Diego Clinical Research Network presents:

 

BIOTECH PRIMER: CURRENT SCIENCE TRENDS, ISSUES, AND ADVANCES

Emily Burke, Ph.D., BioTech Primer

June 30, 2014. 5:30 to 8:00 p.m.

SheppardMullin Law Firm, 12275 El Camino Real, Del Mar, CA 92130

 

Emily Burke, Ph.D., Director of Curriculum at BioTech Primer, will provide an overview of the most exciting biotech innovations in the past year, and the science behind them, to San Diego Clinical Research Network and friends. This event is open to the public.

 

AGENDA

5:30-6:15 p.m. Appetizers, drinks, networking

6:15-7:30 p.m. Speaker: Emily Burke, Ph.D.

7:30-8:00 p.m. Networking

 

This is a great opportunity to get a big-picture view and understanding of recent innovations in the rapidly changing biotechnology industry, and to network with others in the industry.

http://www.eventbrite.com/e/biotech-primer-current-science-trends-issues-and-advances-registration-11041055093

International Regulatory Science Symposium

June 10th, 2014

Register now for the International Regulatory Science Symposium – June 19th, 2014 – Register Now!

We hope you will join us on June 19 from 9 am to 3 pm.  The topics for this one-day “International Regulatory Science Symposium” will relate to the theme of global collaboration and innovation, presented by internationally renowned experts from academia, regulatory authority, and industry.

This opportunity is recommended to those interested in global biomedical research and development, regional regulatory policies, and international collaborative activities.

International Regulatory Science Symposium

2014 Summerfest Kickoff

“Collaborate, Innovate, Globalize”

When:  Thursday, June 19, 9 am to 3 pm

Where: Aresty Auditorium at the Harlyne J. Norris Research Tower

USC Health Sciences Campus

1450 Biggy Street Lower Ground Level

Los Angeles, CA 90033

This symposium is offered to USC Faculty at no charge and to industry professionals for a registration fee of $149, which will go toward the USC Regulatory Science Scholarship Fund. 

Breakfast and lunch are included.  Register and more info here.

SABPA Bio-Pharma Conference 2014

May 9th, 2014

Date:                     June 21, 2014, 8:00am – 4:50pm

Location:               Hilton, SanDiego/Del Mar

Website:                http://www.sabpa.org/html

Registration:

$30 for early birds (by June 11th), $50 before end of June 18th, $80 for onsite registration,students and postdocs $10 off (The fee includes continental breakfast, coffee, lunch, parking at the hotel, and the program brochure).

Online registration closes after June 18th.

Organizer:             Sino-American Biotechnology and Pharmaceutical Professionals Association (SABPA)

Co-organizers:      BayHelix, SDCAA (San Diego Chinese American Association), ACS-SD (American Chemical Society – San Diego), UCSD

 

Bio-Pharma conference, SABPA’s annual flagship event, is fast approaching. With the recent waves of IPOs, mergers & acquisitions, and new drug approvals, this year we will showcase many San Diego biopharma companies and research institutes that are pushing the boundaries with breakthroughs in therapeutics ranging from small molecules, to proteins, nucleic acids and somewhere in between. You will hear many success stories from notable companies such as Celgene and Aragon. This conference will also bring together many business leaders from around the globe with renewed enthusiasm for investing in the San Diego biotechnology industry to share their insights on industry trends. The program is guaranteed to generate sizzling discussions and stimulate new ideas.

 

Program

 

8:00am     Exhibition (all day)

8:00am     Continental Breakfast & Registration

8:45am     Welcome

9:00am     Keynote Speaker:

Thomas Daniel, MD, Executive Vice President and President of Global Research & Early Development, Celgene Corporation

9:40am     Session I

Alan Lewis, PhD, CEO, Medistem

 

10:40am     Coffee Break

11:00am     Session II Panel Discussion: 2014 San Diego Biotech in Focus

12:00pm     Luncheon

1:30pm       San Diego Bio-Pharma Achievement Award

Award Recipient: Richard Heyman, PhD, President and CEO, Seragon Pharmaceuticals

2:10pm       Session III

Alan Paau, CLP, MBA, PhD, Executive Dir. & Vice Provost for Tech. Transfer & Economic Development, Cornell University

                   David Kabakoff, PhD, Executive Partner, Sofinnova Ventures

3:10 pm     Coffee Break

3:30 pm     SessionIV Panel Discussion: Innovation, translation, and business transactions on a global scale

4:30 pm     SessionV Presentation from a Chinese Delegation

4:50 pm     Closing

 

Calling for sponsorship! Please contact: sponsorship@sabpa.org