Fall Hours • COVID-19 Update

The Silicon Valley Campus is open 4–9:30 p.m. on Monday–Friday and 8 a.m.–5 p.m. on Saturday.

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Courses

Certificate courses open for enrollment

Upskill in 30 Days or Less

Comment Showing 23 courses for regulatory affairs.

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Principles of Drug Discovery and Development

BTEC.X415
Units: 4.0
Start / End Date
Cost
Instructor
Location
Section ID
01-20-2022 to 03-28-2022
$965
Edward James Rozhon
Remote
BTEC.X415.(6)
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Drug Safety and Adverse Events Reporting

CTDM.X409
Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
12-04-2021 to 12-11-2021
$550
Narinder Singh
Santa Clara
CTDM.X409.(9)
Enroll
See complete class schedule here.

European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance

Bullhorn New
REGL.X408
Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID
01-20-2022 to 04-07-2022
$875
Bharat (Bill) C Kurani
Remote
REGL.X408.(5)
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Data Privacy and Security for Healthcare and Biosciences

Bullhorn New
CTDM.X407
Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
11-16-2021 to 12-21-2021
$625
Thomas R Pamukcu
Remote
CTDM.X407.(5)
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Post-Market Regulatory Obligations for Medical Devices

MEDD.X406
Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
01-11-2022 to 03-27-2022
$750
Clarisa A Tate
Online
MEDD.X406.(805)
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Regulation of in vitro Diagnostics in Europe and the US

MEDD.X408
Units: 2.5
Start / End Date
Cost
Instructor
Location
Section ID
01-06-2022 to 02-17-2022
$815
David G Kern
Remote
MEDD.X408.(7)
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Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment

Bullhorn New
REGL.X410
Units: 2.0
Start / End Date
Cost
Instructor
Location
Section ID
01-11-2022 to 02-22-2022
$795
Clarisa A Tate
Remote
REGL.X410.(2)
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Regulation of Drugs & Biologics: Strategic Biopharmaceutical Product Development

Bullhorn New
REGL.X411
Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID
11-10-2021 to 01-12-2022
$875
Sheldon L Mullins
Remote
REGL.X411.(2)
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Value-Added Quality Audits

REGL.X407
Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
02-19-2022 to 02-26-2022
$750
Kiran Gulati
Remote
REGL.X407.(5)
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Preparing for FDA Inspections and Conducting Sponsor Audits

CTDM.X414
Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
10-29-2021 to 11-19-2021
$625
Jeaneen C Wallis
Santa Clara
CTDM.X414.(5)
Enroll
See complete class schedule here.

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

MEDD.X407
Units: 3.0

Currently no classes scheduled. Would you like to be notified when a class is available?

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Design Control for Medical Devices

MEDD.X400
Units: 2.0

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Good Clinical Practices

CTDM.X411
Units: 3.0

Currently no classes scheduled. Would you like to be notified when a class is available?

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Good Manufacturing Practices

REGL.X400
Units: 3.0

Currently no classes scheduled. Would you like to be notified when a class is available?

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Communicating and Negotiating with the FDA

REGL.X402
Units: 1.5

Currently no classes scheduled. Would you like to be notified when a class is available?

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Regulation of Medical Devices and Diagnostics

REGL.X404
Winter TBD
Units: 3.0

Currently no classes scheduled. Would you like to be notified when a class is available?

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Risk Management for Regulated Industries

MEDD.X409
Units: 3.0

Currently no classes scheduled. Would you like to be notified when a class is available?

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Validating Software for Medical Devices and Emerging Technologies

MEDD.X410
Units: 2.0

Currently no classes scheduled. Would you like to be notified when a class is available?

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Regulation of Drugs and Biologics

REGL.X403
Units: 3.0

Currently no classes scheduled. Would you like to be notified when a class is available?

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Regulatory Submissions: Devices and Diagnostics

REGL.X405
Units: 2.5

Currently no classes scheduled. Would you like to be notified when a class is available?

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Global Medical Device Submissions and Strategy

REGL.X401
Units: 1.5

Currently no classes scheduled. Would you like to be notified when a class is available?

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

Bullhorn New
REGL.X409
Units: 2.0

Currently no classes scheduled. Would you like to be notified when a class is available?

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Clinical Trials Essentials: An Intensive One-Week Course

CTDM.801
Units: 3.5

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Certificate courses open for enrollment

Upskill in 30 Days or Less