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Comment Showing 23 courses for regulatory affairs.

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Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements

MEDD.X407
Quarter Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID
09-12-2022 to 10-31-2022
$815
Kiran Gulati
Remote
MEDD.X407.(11)
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Good Clinical Practices

CTDM.X411
Quarter Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID
09-01-2022 to 10-27-2022
$740
Jeaneen C Wallis
Remote
CTDM.X411.(12)
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Design Control for Medical Devices

MEDD.X400
Quarter Units: 2.0
Start / End Date
Cost
Instructor
Location
Section ID
10-29-2022 to 12-10-2022
$795
Farhan Shahab
Remote
MEDD.X400.(9)
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Data Privacy and Security for Healthcare and Biosciences

Bullhorn New
CTDM.X407
Quarter Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
11-07-2022 to 12-12-2022
$625
Thomas R Pamukcu
Online
CTDM.X407.(7)
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Global Medical Device Submissions and Strategy

REGL.X401
Quarter Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
10-01-2022 to 10-15-2022
$750
Patrick Lee
Remote
REGL.X401.(8)
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Regulatory Submissions: Devices and Diagnostics

REGL.X405
Spring TBD
Quarter Units: 2.5
Start / End Date
Cost
Instructor
Location
Section ID
09-01-2022 to 11-17-2022
$860
Craig Coombs
Santa Clara / Remote
REGL.X405.(6)
Enroll
See complete class schedule here.

Foundations in U.S. FDA Regulations of Drugs & Biologics and Regulatory Submissions

Bullhorn New
REGL.X409
Quarter Units: 2.0
Start / End Date
Cost
Instructor
Location
Section ID
08-29-2022 to 10-03-2022
$795
Sheldon L Mullins
Remote
REGL.X409.(4)
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European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance

REGL.X408
Quarter Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID
09-01-2022 to 11-10-2022
$875
Bharat (Bill) C Kurani
None
REGL.X408.(6)
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Regulation of Drugs & Biologics: Strategic Biopharmaceutical Product Development

Bullhorn New
REGL.X411
Quarter Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID
10-04-2022 to 12-20-2022
$875
Sheldon L Mullins
Remote
REGL.X411.(4)
Enroll

Value-Added Quality Audits

REGL.X407
Quarter Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
08-20-2022 to 08-27-2022
$750
Kiran Gulati
Remote
REGL.X407.(6)
Enroll

Preparing for FDA Inspections and Conducting Sponsor Audits

CTDM.X414
Quarter Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
10-28-2022 to 12-02-2022
$625
Jeaneen C Wallis
Remote
CTDM.X414.(7)
Enroll

Principles of Drug Discovery and Development

BTEC.X415
Quarter Units: 4.0

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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Regulation of in vitro Diagnostics in Europe and the US

MEDD.X408
Quarter Units: 2.5

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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Drug Safety and Adverse Events Reporting

CTDM.X409
Fall TBD Spring TBD
Quarter Units: 1.5

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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Communicating and Negotiating with the FDA

REGL.X402
Fall TBD Spring TBD
Quarter Units: 1.5

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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Good Manufacturing Practices

REGL.X400
Quarter Units: 3.0

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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Risk Management for Regulated Industries

MEDD.X409
Fall TBD Spring TBD
Quarter Units: 3.0

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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Validating Software for Medical Devices and Emerging Technologies

MEDD.X410
Quarter Units: 2.0

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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Post-Market Regulatory Obligations for Medical Devices

MEDD.X406
Quarter Units: 1.5

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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Regulation of Medical Devices and Diagnostics

REGL.X404
Winter TBD
Quarter Units: 3.0

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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Regulation of Drugs and Biologics

REGL.X403
Quarter Units: 3.0

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment

Bullhorn New
REGL.X410
Quarter Units: 2.0

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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Clinical Trials Essentials: An Intensive One-Week Course

CTDM.801
Summer TBD
CEU: 3.5 CEUs

Currently no classes scheduled. Would you like to be notified when a class is available or get the estimated cost?

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