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March 30, 2020
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
FDA's Guidance on Process Validation for Drugs and Biologics - 3 Steps to Compliance
Course Duration:
60 Minutes
New Rules for FDA Regulation for Lab Developed Diagnostic Tests(LDT)
Course Duration:
60 Minutes
FDA Compliant QC and QA Practices: How to Create a Perfect FDA Audit-Ready QMS
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
Five Steps to Manage the Temporary Shutdown and Restart of a GMP Facility
Course Duration:
60 Minutes
FDA’s Requirements for a Dear Doctor Letter
Course Duration:
60 Minutes
How to Create Flow Charts for Your SOPs: Visual Tools for Increased Compliance
Course Duration:
60 Minutes
Raw Materials Risk Management in GMP Facilities Avoiding GMP Non-Compliance
Course Duration:
60 Minutes
Safety Reporting in Clinical Trials: Are you Compliant with the Current FDA Rules?
Course Duration:
60 Minutes
How to Withstand an FDA Audit of Your Facility
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
How and When to Use a US Agent When Dealing with the FDA
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
3D Printing for Manufacturing Regulated Products: FDA’s Current Acceptance and Future Projections
Course Duration:
60 Minutes
How to Make Efficient FDA-Compliant Clinical Protocol Amendments
Course Duration:
60 Minutes
How Apply for a Breakthrough Therapy Designation and Win It
Course Duration:
60 Minutes
Regulatory Strategies for Small and Medium Companies
Course Duration:
60 Minutes
Good Documentation Practices for FDA-Regulated Industry
Course Duration:
60 Minutes
CMC Considerations for INDs and NDAs for 505(b)(2) Products
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
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