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.

FDA Compliant Vendor Validation Programs

How to Find the Best CRO for Your Clinical Trial

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

New 510k for Modified 510k-Cleared or 510k-Exempt Devices: Best Practices

Expedited Approval Pathways in the US: Best Ways to Get the Most Incentives

How to write a good Clinical Study Report (CSR) for FDA submission

FDA Rules for Investigating Out-of-Specification (OOS) Test Results

Cleaning Validation for GMP Facilities

CMC Considerations for INDs and NDAs for 505(b)(2) Products

HIPAA Training and Certification for Clinical Trial Professionals: What Applies, What Doesn't

Development and Marketing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) In the US

Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs

Social Media and Clinical Trials: Patient-Physician Interactions, Patient-Patient Interactions

Opioid Pain Management, FDA Regulations and Requirements for Good Clinical Practice

Using Excel Spreadsheets in FDA Regulated Environment

Good Documentation Practices for FDA-Regulated Industry

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

How to Ace an FDA Meeting

Challenges in Clinical Trial Start-up

How to Create an Electronic Informed Consent

Is Your Facility Validated for cGMP? 5 Steps to Compliance with FDA

How to Use FDA's Guidance Documents To Your Advantage

Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials

FDA IND Submission for a Product

Cybersecurity and FDA: Navigating FDA Rules for Cybersecurity in Regulated Products

How to Increase the Odds for Success of Your 505(b)(2) Product

5 Steps to Finding the Best Sites for Your Clinical Trial

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On Demand Webinars

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