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20th Annual OCRA Educational Conference June 7-8, 2017

on May 16, 2017 Conferences 680 Views

 

Wednesday, June 7, 2017
Plenary Sessions 

7:00 am - 5:00 pm   

 

Keynote Presentation: FDA Key Accomplishments and Strategic Initiatives 

Alonza Cruse, Pharmaceutical Quality Program Director, FDA 
(former Director, FDA Los Angeles District) 


21st Century Cures Act

Wade Ackerman, Partner, Food, Drug and Device Group, Covington & Burling 

John Sheets, PhD, Principal, Thoughtstorm Innovation 

 

The 5 year reauthorization of PDUFA, MDUFA, BsUFA and GDUFA

Wade Ackerman, Partner, Food, Drug and Device Group, Covington & Burling  

 

Interactions between State FDB, Regional FDA and FDA Centers
2016 accomplishments and 2017 Strategies

Harlan Loui, Chief, Drug and Medical Device Section, California Department of Public Health, Food and Drug Branch

 

Cybersecurity

Shep Bentley, Principal Consultant, Bentley Biomedical Consulting, LLC

 

Compliance at the Ports and Changes Needed for ACE
Carla Fernandez-Borges, Supervisory Consumer Safety Officer, FDA Import Operations
Dan Solis, Director Import Operations, FDA Los Angeles District 

 

End of Day Panel Discussion with all Speakers

 

Immediately following the conference, all attendees are invited to 

OCRA's Member Appreciation Night exhibit show and networking event. 

 

 

Thursday, June 8, 2017
Breakfast and Breakout Sessions

7:00 am - 5:00 pm

Breakfast Session - Resources available to Orange County Health Care Industry

Jim Mayfield, Director, US Commercial Service, Orange County Export Assistance Center

Tembi Secrist Director, Global Healthcare Team, US Department of Commerce

Linda DiMario VP, Economic Development/Tourism, Greater Irvine Chamber of Commerce

Dennis Wright, Regional Specialist at SCORE

 

Medical Device and IVD Breakouts

1. Big Data / NEST (The National Evaluation system for Health Technology)

Ann Ferriter, Director, Division of Analysis/Program Operations, CDRH/OC, FDA
Carl Wyrwa, Consultant, CW Software Solutions, Inc. 

 

2. Clinical Equivalence - How Far Has the Bar Been Raised? Time can shift

Rene Bombien, MD, Cardiac Surgeon, TÜV SÜD 
Vincent Legay, PhD, Manager, European Department for Regulatory & Biological Safety Services, NAMSA 

 

3. Premarket Strategies for Medical Devices

Heather Rosecrans, Executive VP, Medical Devices & Combination Products   
    Greenleaf Health LLC (former Director Premarket Notification (510(k)) FDA) 

Dan Schultz, Principal, Medical Devices & Combination Products
    Greenleaf Health LLC (former Director, CDRH, FDA)

John Sheets, PhD, Principal, Thoughtstorm Innovation 

 

4. European MDR/IVDR 

Chris Sarner, Sr. Project Manager, Certification Medical Devices, DEKRA Certification B.V. 

 

Drugs and Biologics Breakouts

1. Everything You Wanted to Know About ClinicalTrials.gov But Were Afraid to Ask

Cindy Fisher, PhD, RAC, Director, Regulatory Affairs, Vical Incorporated
Marguerite Prior, PhD, Senior Associate, Regulatory Affairs, Intercept Pharmaceuticals 

 

2. High Throughput Formulation Strategies for Biotherapeutics

Rajiv Nayar, PhD, President, HTD Biosystems 
Christa Myers, Process Chemical Engineer and Senior Pharmaceutical Engineering Specialist, CRB 

 

3. Combination Products - Challenges and Opportunities

James Wabby, Director, Regulatory Intelligence and Compliance,  Medical Devices and Combination Products, Allergan 
Marimer Escobar, Sr. Associate Scientist, Amgen 

 

4. Team Biologics

Gene Arcy, Consumer Safety Officer, Team Biologics, FDA Los Angeles District
Barb Unger, President, Unger Consulting 

   

Dietary Supplements Breakouts

1. GMPS/QSIT/HACCP
Joy Joseph, President, Joys Quality Management Systems

2. Compliance with Dietary Supplement Regulations
Sara Dent-Acosta, Food Specialist, FDA Los Angeles District 

Nora Dowell, VP, Quality/Regulatory Affairs, IVC - International Vitamin Corp. 

 

3. Supply Chain Controls 

Ann Ferriter, Director, Division of Analysis/Program Operations, CDRH/OC, FDA 
Tanya Malais, Consumer Safety Officer, FDA Los Angeles District Office 


4. Compliance Issues and Trends

Ray Brullo, DPM, Compliance Officer, FDA Los Angeles District
Teresa Cain, PhD, Compliance, Officer, FDA Los Angeles District 

 

Followed by an end of day Q&A with all speakers from all sessions.

See your inbox for updates as more speakers are confirmed! 

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About OCRA:

Orange County Regulatory Affairs Discussion Group (OCRA) was organized in 1992 and incorporated in 1994. OCRA is chartered as a nonprofit educational group, and received 501(c)(3) nonprofit status in 1999. OCRA's goals are to promote an atmosphere for open exchange of ideas and discussion for the regulatory affairs professional from the medical device, pharmaceutical, biological and dietary supplement industries. OCRA is a "grass roots" volunteer organization dedicated to service the needs of its membership.

OCRA seeks to provide a neutral forum for the exchange of information and views regarding issues, problems and activities of interest to the regulatory affairs profession. OCRA's purposes include the education of regulatory affairs professionals regarding developments in the regulation of the industry by the FDA, its state counterparts, and other regulatory agencies.

Experience has shown that OCRA conferences can be effective in reaching a large number of influential members of the regulated industry who, in turn, can multiply the effect by taking the training back to their firms. Our conferences help provide clear expectations of legal requirements and Agency expectations, resulting in more cooperation toward the common goals of protecting the public health.

 

REGISTRATION INFORMATION 

Online Registration Instructions: 

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 "Sign up" on the 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. 

 

If you do not know your username or password, click on "Forgot login?" (which is located on the right side halfway down the page) and follow the steps. You can also email or call us for a password reset. 

 

Step 3:  

Once you have logged on (and paid for membership) click the "Home" tab then select the meeting you would like to attend by clicking on it under "Upcoming Events" and complete the registration process by filling in the appropriate fields.

Non Members

If you are not an OCRA Member, we require you to join OCRA before registering for this meeting.  

 

MULTIPLE REGISTRATIONS: 

Our system is set up for one registration at a time. To register multiple people from your company, you can simplify the process by faxing us a cover page on your company letterhead with your credit card number and expiration date or let us know that a check will be mailed (checks should be received prior to the event). Please provide a registration form for each attendee. If you need a receipt, please let us know to whom it should be emailed.

Fax Registrations Accepted
Please download the event flyer, complete the registration form then fax to 949-266-8461. 

 

To Register With Company or Personal Check: Please submit the online registration form. Mail your check made payable to OCRA to the following address: Orange County Regulatory Affairs Discussion Group, 5319 University Dr., Suite 641, Irvine, CA 92612

Tel:         949-387-9046                       

Fax:        949-266-8461           

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

Registration Help? Email Rob.Fleming@yahoo.com

Registration Rate  

$795 OCRA Members   

 

$870 Non-members 
(includes OCRA membership for one year)

$750 One Day Exhibitor During Conference on Wednesday*  

(includes 6'x2.5' table during the conference and at Member Appreciation Night and one representative)* 

 

$750 One Day Exhibitor During Conference on Thursday* 

(includes 6'x2.5' table during the conference and at Member Appreciation Night and one representative)*

$1400 Two Day Exhibitor During Conference*  

(includes 6'x2.5' table during the conference and at Member Appreciation Night and one representative)*  

$475 FDA/Government/Students**  

(rate not available for online registration, please fax this form)

* Rate does not include conference attendance. To exhibit and attend conference, please register for both.

** 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. We do not offer online registration at this rate as it requires approval. Please fax this form with payment and items described above (if applicable).

There are no one day options for this conference.

 

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.

  

 

Cancellations

For a refund, please email your cancellation request to Rob Fleming (rob.fleming@yahoo.com) by May 19th, 2017.

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DRIVING DIRECTIONS       

The Westin South Coast Plaza 

686 Anton Blvd., Costa Mesa, CA 92626

Free shuttle from John Wayne Airport (SNA) 

http://www.westinsouthcoastplaza.com/

May 10 Deadline for Special OCRA Rate $189 single/double occupancy:  Call 888-627-7213 and ask for the OCRA2017 rate. 

   

Directions to Westin South Coast Plaza:
From Los Angeles: 
Take 405 South, 
Exit at Bristol. 
Turn Left on Bristol.
Turn Right on Anton
Turn Left on Park Center Dr. 
Hotel will be on the Left.

From San Diego: 
Take 5 North to 405 North. 
Exit at Anton Blvd. Turn Left on Anton. 
Turn Right on Park Center Dr. 
Hotel will be on the Left.

ee59cab4-aba7-4a90-b6bf-61d37b4a6d03.jpg 

 

It is recommended that you look up driving directions from your own starting point.

 

Kimberly Syre, OCRA Administrator 

Attention To Detail (Management Company) 

5319 University Dr., Suite 641

Irvine, CA  92612

Tel:    949-387-9046

Fax:   949-266-8461

 

 

 

 

 

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