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July 14 , 2021
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August 25, 2021
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September 1, 2021
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September 10, 2021
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September 14, 2021
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September 17, 2021
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September 24, 2021
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September 27, 2021
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September 29, 2021
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October 1, 2021
How and When to Use a US Agent When Dealing with the FDA
Course Duration:
60 Minutes
FDA Regulation of Molecular Diagnostics
Course Duration:
60 Minutes
How to Make Efficient FDA-Compliant Clinical Protocol Amendments
Course Duration:
60 Minutes
FDA Compliant Vendor Validation Programs
Course Duration:
60 Minutes
FDA Compliant Use of Smartphone, Smartwatch, and Apps in Clinical Trials
Course Duration:
60 Minutes
How to Write Perfect FDA-Compliant SOPs: Stepwise Instructions
Course Duration:
60 Minutes
Software Validation: Avoiding FDA Warning Letters and Consent Decree
Course Duration:
60 Minutes
How to Find the Best CRO for Your Clinical Trial
Course Duration:
60 Minutes
FDA IND Submission for a 505(b)(2) Product
Course Duration:
60 Minutes
Opioid Pain Management, FDA Regulations and Requirements for Good Clinical Practice
Course Duration:
90 Minutes
How to Use FDA’s Guidance Documents To Your Advantage
Course Duration:
60 Minutes
Managing Supplies in Your Clinical Trial: FDA Compliant Supply Chain Management
Course Duration:
60 Minutes
FDA Approved Adaptive Clinical Trials: Smart Trial Design for Drugs, Biologics and Devices
Course Duration:
60 Minutes
Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs
Course Duration:
60 Minutes
Best Practices for Writing an Investigator’s Brochure
Course Duration:
60 Minutes
Drug Master Files – Helping with FDA DMFs
Course Duration:
60 Minutes
FDA Compliant Warehouse and Distribution Practices
Course Duration:
60 Minutes
Is Your Facility Validated for cGMP? 5 Steps to Compliance with FDA
Course Duration:
60 Minutes
Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials
Course Duration:
60 Minutes
Five Best Practices for Using Email in FDA Regulated Industry
Course Duration:
60 Minutes
Investigating Out-of-Specification (OOS) Test Results in the Laboratory – FDA’s Expectations
Course Duration:
60 Minutes
Preclinical Testing for Drug and Biologics: Meeting FDA Requirements Without Breaking the Bank
Course Duration:
60 Minutes
Regulatory Issues with Developing Companion Diagnostics: FDA Policies and Expectations Clarified
Course Duration:
60 Minutes
Safety Reporting in Clinical Trials: Are you Compliant with the Current FDA Rules?
Course Duration:
60 Minutes
Using Excel Spreadsheets in FDA Regulated Environment
Course Duration:
60 Minutes
Avoid Data Integrity Issues: How to Audit a CRO and Other Vendors
Course Duration:
60 Minutes
5 Steps to Finding the Best Sites for Your Clinical Trial
Course Duration:
60 Minutes
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