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Medical Device Compliance Training

Learn the best practices from experts through training programs to meet the Medical Device regulations. This section constitutes of Medical Device regulation based trainings in areas of calibration, product development, design controls, process validation, safety, establishment registration and device listing, MDR, QSR regulations, ISO 13485, and ISO 14971, 510K, IDE, PMA & Recalls
 
  A Comprehensive Overview of 510(K) submission

Instructor : David Lim

$299.00
$449.00
  Supplier Evaluation and Assessment - FDA QSR and ISO 13485 Requirements

Instructor : Jeff Kasoff

$249.00
$450.00
  Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees

Instructor : Robert J Russell

$349.00
$549.00
  4-hr Virtual Seminar - Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)

Instructor : Robert J Russell

$399.00
$849.00
  Complaint Handling in Compliance with FDA and ISO Regulations

Instructor : Jeff Kasoff

$299.00
$500.00
  Design History Files, Device Master Records, Device History Records, and Technical Files / Design Dossiers -- Differences and Similarities

Instructor : John E Lincoln

$399.00
$549.00
  DMR & DHR - What Is Really Required

Instructor : Daniel O Leary

$399.00
$549.00
  FDA's Oversight of Mobile Medical Applications ("apps") for Use on Smartphones and Similar Mobile Devices

Instructor : Karl M. Nobert

$349.00
$549.00
  You have a Sterility Failure or Bioburden Excursion - Now What?

Instructor : Gerry O Dell

$299.00
$500.00
  Equipment Calibration in FDA QSR – Regulations and Warning Letters

Instructor : Daniel O Leary

$349.00
$549.00
  Designing Medical Device Alarms to Mitigate New FDA Concerns

Instructor : Dev Raheja

$299.00
$449.00
Device Corrections and Removals

Instructor : Daniel O Leary Live Friday, June 1, 2012 | 08:00 AM PDT | 11:00 AM EDT

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Service Level Agreements (SLAs) - Preparation Guidelines for Effective SLAs

Instructor : Javier Kuong Live Monday, June 4, 2012 | 09:00 AM PDT | 12:00 PM EDT

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ICH Q10; moving from GMPs to a Pharmaceutical Quality System

Instructor : John G Lanese Live Tuesday, June 5, 2012 | 10:00 AM PDT | 01:00 PM EDT

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The 21 Elements of a 510(k)

Instructor : John E Lincoln Live Tuesday, June 5, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Verification and Validation (V&V) of Software in the Medical Devices

Instructor : Dev Raheja Live Wednesday, June 6, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Unsolicited Drug and Device Off-Label Claims Via Social Media and Risk Management

Instructor : Charles R. McConachie Live Wednesday, June 6, 2012 | 10:00 AM PDT | 01:00 PM EDT

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CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment

Instructor : Barry Craig Live Thursday, June 7, 2012 | 10:00 AM PDT | 01:00 PM EDT

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FDA 510k program
FDA 510k program
FDA 510k program