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August 27, 2024
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How Apply for a Breakthrough Therapy Designation and Win It
Course Duration:
60 Minutes
Avoid Data Integrity Issues: How to Audit a CRO and Other Vendors
Course Duration:
60 Minutes
Trial Master File (TMF): FDA Expectations from Sponsors and Sites
Course Duration:
60 Minutes
New 510k for Modified 510k-Cleared or 510k-Exempt Devices: Best Practices
Course Duration:
60 Minutes
Expedited Approval Pathways in the US: Best Ways to Get the Most Incentives
Course Duration:
60 Minutes
How to write a good Clinical Study Report (CSR) for FDA submission
Course Duration:
60 Minutes
Investigating Out-of-Specification (OOS) Test Results in the Laboratory – FDA’s Expectations
Course Duration:
60 Minutes
Cleaning Validation for GMP Facilities
Course Duration:
60 Minutes
Unveiling the Power of Real-World Evidence in Healthcare Research
Course Duration:
60 Minutes
Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs
Course Duration:
60 Minutes
Pragmatic Trials: Bridging Theory to Practice in Healthcare Research
Course Duration:
60 Minutes
CMC Considerations for INDs and NDAs for 505(b)(2) Products
Course Duration:
60 Minutes
HIPAA Training and Certification for Clinical Trial Professionals: What Applies, What Doesn't
Course Duration:
60 Minutes
Development and Marketing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) in the US
Course Duration:
60 Minutes
Preclinical Testing for Drug and Biologics: Meeting FDA Requirements Without Breaking the Bank
Course Duration:
60 Minutes
Social Media and Clinical Trials: Patient-Physician Interactions, Patient-Patient Interactions
Course Duration:
60 Minutes
How to Create an Electronic Informed Consent
Course Duration:
60 Minutes
Good Documentation Practices for FDA-Regulated Industry
Course Duration:
60 Minutes
How to Start a New Clinic as a Trial Site
Course Duration:
60 Minutes
Using Excel Spreadsheets in FDA Regulated Environment
Course Duration:
60 Minutes
Challenges in Clinical Trial Start-up
Course Duration:
60 Minutes
FDA Compliant Warehouse and Distribution Practices
Course Duration:
60 Minutes
GLP Simplified: Meeting FDA Requirements without Breaking the Bank
Course Duration:
60 Minutes
Safety Reporting in Clinical Trials: Are you Compliant with the Current FDA Rules?
Course Duration:
60 Minutes
Is Your Facility Validated for cGMP? 5 Steps to Compliance with FDA
Course Duration:
60 Minutes
How to Ace an FDA Meeting
Course Duration:
60 Minutes
Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials
Course Duration:
60 Minutes
FDA Rules for Cybersecurity Measures in Regulated Products
Course Duration:
60 Minutes
How to Use FDA’s Guidance Documents To Your Advantage
Course Duration:
60 Minutes
Dispute Resolutions with FDA: Clinical, GMP, and Application Reviews
Course Duration:
60 Minutes
FDA Requirements for Creating New Mobile Endpoints for Clinical Trials
Course Duration:
60 Minutes
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