Computer System Validation

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Testing, based on risk

  • 11-October-2018| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

CGMP Inspections / Auditing -- Internal and External

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

Past “good” inspections are no indication of future inspection

  • 17-October-2018| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Implementation and Management of GMP Data Integrity

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

Data integrity is assuming greater importance in CGMP for US FDA regulated industry

  • 21-August-2018| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
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