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.

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

Strategies for Minimizing Preclinical Testing: Meeting FDA Requirements without Breaking the Bank

On Demand Webinars

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