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April 26, 2021
Best Practices for Clinical Trial Risk Management: Common Issues and Potential Solutions
Course Duration:
60 Minutes
FDA is Changing GMP Audit Practices: Are You Ready?
Course Duration:
60 Minutes
10 Steps to the Perfect Clinical Trial Protocol: FDA-Compliant Protocol Development
Course Duration:
60 Minutes
How to Create Flow Charts for Your SOPs: Visual Tools for Increased Compliance
Course Duration:
60 Minutes
Social media as a recruitment tool for clinical trials: The Best, the Worst, and the Balanced
Course Duration:
60 Minutes
Strategies for 510(k) Applications for Software or Software Containing Medical Devices
Course Duration:
60 Minutes
Good Tissue Practices and GMP for HCT/P and Stem Cell Therapies
Course Duration:
60 Minutes
FDA Rules for Cybersecurity Measures in Regulated Products
Course Duration:
60 Minutes
FDA Regulation of Molecular Diagnostics
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
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
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
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
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
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
How to Make Sure Your Foreign Vendor is FDA Compliant and Stays That Way
Course Duration:
60 Minutes
FDA Rules for Use of Social Media in Marketing Regulated Products
Course Duration:
60 Minutes
How to Ace an FDA Meeting
Course Duration:
60 Minutes
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