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Comment Showing 23 courses for regulatory affairs.

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Principles of Drug Discovery and Development

BTEC.X415
Quarter Units: 4.0
Start / End Date
Cost
Instructor
Location
Section ID
06-26-2023 to 08-31-2023
$965
Edward James Rozhon
Remote
BTEC.X415.(9)
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Regulation of in vitro Diagnostics in Europe and the US

MEDD.X408
Quarter Units: 2.5
Start / End Date
Cost
Instructor
Location
Section ID
06-15-2023 to 07-27-2023
$815
David G Kern
Remote
MEDD.X408.(10)
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Good Manufacturing Practices

REGL.X400
Quarter Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID
08-12-2023 to 09-10-2023
$875
Narinder Singh
Online
REGL.X400.(10)
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Post-Market Regulatory Obligations for Medical Devices

MEDD.X406
Quarter Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
06-16-2023 to 08-31-2023
$750
Clarisa A Tate
Online
MEDD.X406.(808)
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Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment

REGL.X410
Quarter Units: 2.0
Start / End Date
Cost
Instructor
Location
Section ID
07-11-2023 to 08-15-2023
$795
Clarisa A Tate
Remote
REGL.X410.(5)
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Value-Added Quality Audits

REGL.X407
Quarter Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
07-15-2023 to 07-22-2023
$750
Kiran Gulati
Remote
REGL.X407.(8)
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Preparing for FDA Inspections and Conducting Sponsor Audits

CTDM.X414
Quarter Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
06-02-2023 to 06-23-2023
$625
Jeaneen C Wallis
Remote
CTDM.X414.(8)
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Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements

MEDD.X407
Quarter Units: 3.0

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Good Clinical Practices

CTDM.X411
Quarter Units: 3.0

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Design Control for Medical Devices

MEDD.X400
Quarter Units: 2.0

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Drug Safety and Adverse Events Reporting

CTDM.X409
Fall TBD Spring TBD
Quarter Units: 1.5

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Communicating and Negotiating with the FDA

REGL.X402
Fall TBD Spring TBD
Quarter Units: 1.5

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Risk Management for Regulated Industries

MEDD.X409
Fall TBD Spring TBD
Quarter Units: 3.0

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Validating Software for Medical Devices and Emerging Technologies

MEDD.X410
Quarter Units: 2.0

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Data Privacy and Security for Healthcare and Biosciences

CTDM.X407
Quarter Units: 1.5

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

REGL.X409
Quarter Units: 2.0

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Regulation of Medical Devices and Diagnostics

REGL.X404
Winter TBD
Quarter Units: 3.0

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Global Medical Device Submissions and Strategy

REGL.X401
Quarter Units: 1.5

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Regulation of Drugs & Biologics: Strategic Biopharmaceutical Product Development

REGL.X411
Quarter Units: 3.0

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Regulatory Submissions: Devices and Diagnostics

REGL.X405
Spring TBD
Quarter Units: 2.5

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Regulation of Drugs and Biologics

REGL.X403
Quarter Units: 3.0

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

REGL.X408
Quarter Units: 3.0

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Clinical Trials Essentials: An Intensive One-Week Course

CTDM.801
Summer TBD
CEU: 3.5 CEUs

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