On Demand Webinars

Following is a list of webinars which happened recently. You can choose one or more of the following webinars and we will send you the webinar materials, audio/video so that you can listen/watch at your ease.

Best Practices for Clinical Trial Risk Management: Common Issues and Potential Solutions

How to Train Yourself to be a Good Technical Writer

Five Steps to Manage the Temporary Shutdown and Restart of a GMP Facility

FDA is Changing CMP Audit Practices: Are You Ready?

How to "Win" FDA's Support for Your Clinical Development Program

How and When to Use a US Agent When Dealing with the FDA

Five Best Practices for Using Email in FDA Regulated Industry

How to Write Perfect FDA-Compliant SOPs: Stepwise Instructions

Good Tissue Practices and GMP for HCT/P and Stem Cell Therapies

FDA Compliant Vendor Validation Programs

How to Find the Best CRO for Your Clinical Trial

10 Steps to the Perfect Clinical Trial Protocol: FDA-Compliant Protocol Development

Regulatory Issues with Developing Companion Diagnostics: FDA Policies and Expectations Clarified

Managing Supplies in Your Clinical Trial: FDA Compliant Supply Chain Management

FDA's Guidance on Process Validation for Drugs and Biologics - 3 Steps to Compliance

FDA Compliant QC and QA Practices: How to Create a Perfect FDA Audit-Ready QMS

Social media as a recruitment tool for clinical trials: The Best, the Worst, and the Balanced

FDA Regulation of Dietary Supplement Imports into the US

Dispute Resolutions with FDA: Clinical, GMP, and Application Reviews

FDA Requirements for Creating New Mobile Endpoints for Clinical Trials

Auditing for QSR Compliance

How to Make Sure Your Foreign Vendor is FDA Compliant and Stays That Way

FDA IND Submission for a 505(b)(2) Product

FDA Rules for Cybersecurity Measures in Regulated Products

Unveiling the Power of Real-World Evidence in Healthcare Research

Preclinical Testing for Drug and Biologics: Meeting FDA Requirements Without Breaking the Bank

Validation of Excel Spreadsheet for Use in FDA Regulated Environment

FDA Rules for the Content, Tone and Format of an Investigator’s Brochure

FDA Regulated Import and Export of Medical Devices

How to Create Flow Charts for Your SOPs: Visual Tools for Increased Compliance

Drug Master Files – Helping with FDA DMFs

FDA Approved Adaptive Clinical Trials: Smart Trial Design for Drug, Biologics and Devices

FDA Permitted Off-Label Promotion of Regulated Products

Strategies for 510(k) Applications for Software or Software Containing Medical Devices

FDA Regulation of Molecular Diagnostics

Software Validation: Avoiding FDA Warning Letters and Consent Decree

Regulatory Strategies for Small and Medium Companies

Raw Materials Risk Management in GMP Facilities: Avoiding GMP Non-Compliance Due to Raw Material Issues

New Rules for Using Social Media in Marketing FDA Regulated Products

How to Make Efficient FDA-Compliant Clinical Protocol Amendments

How to Withstand an FDA Audit of Your Facility

Safety Reporting in Clinical Trials: Are you Compliant with the Current FDA Rules?

Avoid Data Integrity Issues: How to Audit a CRO and Other Vendors

Trial Master File (TMF): FDA Expectations from Sponsors and Sites

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On Demand Webinars

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