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2018 Year in Review: Medical Device Lessons Learned
Wednesday 12 December 2018, 03:00pm - 07:00pm
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Orange County Regulatory Affairs Discussion Group (OCRA)
You are invited to an Afternoon/Evening Meeting

 2018 Year in Review: Medical Device Lessons Learned

 

 

What new guidance documents and standards were released in 2018? What industry, FDA, and global trends were observed via Warning Letters, Recalls, and other Regulatory information disclosed in 2018? 

4 Hours Towards Your RAC Recertification
All OCRA Meetings Qualify For Recertification Hours

 

Host:
Azita Hedayati, Director of Regulatory and Quality, HORIBA Medical
 

Program Managers and Moderators:
Kim Walker, MS, RAC (US/EU), FRAPS, Global Regulatory, Quality & Clinical Consultant, Kim Walker Consulting
Fatima Naseer, MPharm, Pharmacist, Syntr Health Technologies 

Presenters:
Natalie J. Kennel, RAC, ASQ CQE & CQMgr, President, NJK & Associates
Frances Cohen, President and CEO, Promenade Software, Inc.
Emergo Speaker Invited
Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant
 

Synopsis:
Please join us for a review of lessons learned in 2018. We will review over new guidance documents and standards released or of importance in 2018. Additionally, we will discuss industry, FDA, and global trends from Warning Letters, Recalls, new regulations, and other Regulatory information disclosed in 2018. 

 

View/download the event flyer for more details, schedule, off-line registration form and driving directions.

 

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

Location Horiba Medical, 9755 Research Drive, Irvine, CA 92618
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