You are invited to a Webinar

Educational Opportunity

  

Laser and X-Ray Reports and Regulations

 

Manufacturers of x-rays and instruments with lasers, inclusive of barcode readers, need to submit reports to FDA before entering the US market. These reports are somewhat arcane and rarely discussed in the press and that includes the initial and annual FDA reports for both x-ray sources and laser systems. Applicable governing documents were written in the 1970’s, updated in the 80’s, and remain unchanged as of today. This live webinar will cover how to file x-ray and laser reports, the contents of these reports, annual reporting requirements, and import regulations for these products.

 

April 8, 2020

6:00 pm – 7:30 pm

 

Online Registration: https://www.eventbrite.com/e/laser-and-x-ray-reports-and-regulations-tickets-100027900142

 

1.5 Hours Towards Your RAC Recertification

 

Location:  

Webinar

 

Program Manager:

Kim Walker, MS, RAC (US & EU), FRAPS – Global Regulatory, Quality, & Clinical Consultant

 

Speaker:

Frank Pokrop, Dir. Reg. Affairs, Quidel Corp.

 

 

Cost:

OCRA Members: $25

Non-Members: $100, includes 1-year OCRA membership

Government and Student Members: $10, with student/government ID

Non-Member Government and Student Rate: $45, includes 1-year OCRA membership

 

Speaker Bio

Frank Pokrop.  Frank has worked in the drug and medical device industries for more than 20 years. He is the director of regulatory affairs for Quidel in San Diego (IVD’s). Earlier he managed the auditing of quality management systems at 48 global sites, performed internal investigations and implemented corporate policies. His background includes worldwide submissions, recall management, product launches, vigilance reporting and manufacturing operations. He was a member of MD&DI’s Editorial Advisory Board from 2006-2016.  He volunteered at UC San Diego on the IRB for 4 years and he served as officer in the San Diego Regulatory Affairs Network (SDRAN) from 2010 – 2018. He currently serves on the Board of RAPS.

 

OCRA Registration Instructions

 

To register for this event go to:  https://www.eventbrite.com/e/laser-and-x-ray-reports-and-regulations-tickets-100027900142

 

Please only purchase one ticket per Eventbrite order.  It is important that you register with the email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance.

 

Registration deadline is April 7^th. 

 

No same day registrations will be allowed.

 

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

 

Cancellation Deadline

For a refund, please email your cancellation request to OCRA Program Chair (ocraprogramchair@gmail.com) by April 1, 2020.

 

If you have any questions or require additional information, email OCRA Program Chair (ocraprogramchair@gmail.com).