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May 22, 2023
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July 31, 2023
CMC Considerations for INDs and NDAs for 505(b)(2) Products
Course Duration:
60 Minutes
FDA Rules for Cybersecurity Measures in Regulated Products
Course Duration:
60 Minutes
FDA Compliant QC and QA Practices: How to Create a Perfect FDA Audit-Ready QMS
Course Duration:
60 Minutes
FDA's Guidance on Process Validation for Drugs and Biologics - 3 Steps to Compliance
Course Duration:
60 Minutes
Regulatory Strategies for Small and Medium Companies
Course Duration:
60 Minutes
3D Printing for Manufacturing Regulated Products: FDA’s Current Acceptance and Future Projections
Course Duration:
60 Minutes
Social media as a recruitment tool for clinical trials: The Best, the Worst, and the Balanced
Course Duration:
60 Minutes
10 Steps to the Perfect Clinical Trial Protocol: FDA-Compliant Protocol Development
Course Duration:
60 Minutes
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
New Rules for FDA Regulation for Lab Developed Diagnostic Tests (LDT)
Course Duration:
60 Minutes
How to Create Flow Charts for Your SOPs: Visual Tools for Increased Compliance
Course Duration:
60 Minutes
How to Train Yourselves to be a Good Technical Writer
Course Duration:
60 Minutes
Five Steps to Manage the Temporary Shutdown and Restart of a GMP Facility
Course Duration:
60 Minutes
Software Validation: Avoiding FDA Warning Letters and Consent Decree
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
FDA Compliant Vendor Validation Programs
Course Duration:
60 Minutes
Good Tissue Practices and GMP for HCT/P and Stem Cell Therapies
Course Duration:
60 Minutes
Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials
Course Duration:
60 Minutes
FDA Regulated Import and Export of Medical Devices
Course Duration:
60 Minutes
Drug Master Files – Helping with FDA DMFs
Course Duration:
60 Minutes
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