Live Webinar : Software / Firmware Verification and Validation to Meet Regulatory Requirements

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical,

  • 25-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Best Practices for Investigating Deviations and CAPA to avoid 483 observations

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

This webinar will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations,

  • 04-April-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Regulatory Perspectives on Pharmacogenomics: A Review of Key Issues Faced by FDA

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Submission of pharmacogenomics data as part of a drug or biologic submission, impacts the approval of the submitted product. Complying with FDA requirements on the

  • 30-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes
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