Process Validation General Principles & Practices – Integrating the FDA and EU Guidance; ICH Q8, ICH Q9, ICH Q10 and Quality Metrics

By: John G. Lanese ,President at The Lanese Group, Inc.

ICH guidance documents, US inspectional guidance and how they relate

  • 23-September-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 120 Minutes

Non-conforming Material and Failure Investigation

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Confusing regulations and effectively deal with non-conforming material

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

HIPAA Audit and Enforcement Update — Changes to Penalties and Latest Decisions

By: Jim Sheldon-Dean ,Principal and Director of Compliance Services, Lewis Creek Systems, LLC.

Enforcement actions taken by HHS and state Attorneys General to illustrate

  • 17-September-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 180 Minutes
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