Courses

Comment Showing 25 courses for regulatory affairs.

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Clinical Trials Essentials: An Intensive One-Week Course

CTDM.801
Units: 3.5

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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
11-23-2019 to 12-21-2019
750
Thomas R Pamukcu
CTDM.X407.(1)
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Design Control for Medical Devices

MEDD.X400
+ +
Units: 2.0

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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
09-23-2019 to 12-09-2019
875
Bharat (Bill) C Kurani
REGL.X408.(1)
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Classes are mostly held on Mondays at 06:00PM. See complete schedule here.

Global Medical Device Submissions and Strategy

REGL.X401
Units: 1.5

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Good Clinical Practices

CTDM.X411
Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID
01-10-2020 to 03-20-2020
875
TBD
CTDM.X411.(5)
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Classes are mostly held on Fridays at 06:00PM. See complete schedule here.

Good Manufacturing Practices

REGL.X400
Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID
01-25-2020 to 03-14-2020
875
Romi Behbehanian
REGL.X400.(4)
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Classes are mostly held on Saturdays at 01:00PM. See complete schedule here.

ICH Quality Guidelines: Intent and Overview

BTEC.X414
Units: 2.0

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Interacting with the FDA

REGL.X402
Units: 1.5

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Post-Market Regulatory Obligations for Medical Devices

MEDD.X406
Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID
09-18-2019 to 12-04-2019
750
Clarisa A Tate
MEDD.X406.(803)
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Preparing for FDA Inspections and Conducting Sponsor Audits

CTDM.X414
Units: 1.5

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Principles of Drug Discovery and Development

Bullhorn New
BTEC.X415
Units: 4.0
Start / End Date
Cost
Instructor
Location
Section ID
09-30-2019 to 12-12-2019
965
Edward James Rozhon
BTEC.X415.(1)
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Classes are mostly held on Mondays at 06:00PM. See complete schedule here.
01-23-2020 to 03-26-2020
965
Edward James Rozhon
BTEC.X415.(2)
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Classes are mostly held on Thursdays at 06:00PM. See complete schedule here.

Quality Systems for Medical Devices: FDA QSR and ISO 13485

MEDD.X407
Units: 2.5

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Regulation of Drugs and Biologics

REGL.X403
Units: 3.0

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Regulation of Medical Devices and Diagnostics

REGL.X404
Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID
01-14-2020 to 04-07-2020
875
Clarisa A Tate
REGL.X404.(5)
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Classes are mostly held on Tuesdays at 06:00PM. See complete schedule here.

Regulation of in vitro Diagnostics in Europe and the US

MEDD.X408
Units: 2.5
Start / End Date
Cost
Instructor
Location
Section ID
01-23-2020 to 03-05-2020
1615
David G Kern
MEDD.X408.(3)
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Classes are mostly held on Thursdays at 06:00PM. See complete schedule here.

Regulatory Affairs Certificate Completion Fee

O-CE0364
Start / End Date
Cost
Instructor
Location
Section ID
None
95
TBD
O-CE0364.(010)
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Regulatory Submissions: Devices and Diagnostics

REGL.X405
Units: 2.5
Start / End Date
Cost
Instructor
Location
Section ID
09-26-2019 to 11-21-2019
860
Craig Coombs
REGL.X405.(3)
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Classes are mostly held on Thursdays at 06:00PM. See complete schedule here.

Regulatory Submissions: Drugs and Biologics

REGL.X406
Units: 2.0

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Risk Management for Regulated Industries

MEDD.X409
Units: 3.0

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Validating Software for Medical Devices and Emerging Technologies

MEDD.X410
Units: 2.0
Start / End Date
Cost
Instructor
Location
Section ID
02-15-2020 to 03-07-2020
800
Niranjan Maharajh
MEDD.X410.(3)
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Classes are mostly held on Saturdays at 10:00AM. See complete schedule here.

Value-Added Quality Audits

REGL.X407
Units: 1.5

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