Trends in FDA Compliance and Enforcement for Regulated Computer Systems

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Good Manufacturing, Laboratory and Clinical Practices

  • 07-March-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Medical Device Software 62304 Compliance

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

IEC 62304 provides a standard for design

  • 26-February-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

  • 05-February-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes
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