Upcoming Events

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  Tue, 03 Feb

  FDA Inspection Readiness - Modular Course for Practitioners / 

  Virtual Event

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  03 Feb 2026, 11:00 am GMT-5 – 18 Feb 2026, 1:00 pm GMT-5

  Virtual Event

  Faculty: Charles H. Paul
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  5 days to the event

  Wed, 11 Feb

  Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR / 

  Virtual Event

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  11 Feb 2026, 11:00 am – 12:15 pm GMT-5

  Virtual Event

  Faculty: David Nettleton
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  7 days to the event

  Fri, 13 Feb

  Successfully Investigating Deviations / 

  Virtual Event

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  13 Feb 2026, 11:00 am – 12:15 pm GMT-5

  Virtual Event

  Faculty: Danielle DeLucy
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  11 days to the event

  Tue, 17 Feb

  Human Behavior Under FDA Scrutiny: How Words, Actions, and Reactions Shape Inspection Outcomes / 

  Virtual Event

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  17 Feb 2026, 11:00 am – 1:00 pm GMT-5

  Virtual Event

  Faculty: Charles H. Paul
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  12 days to the event

  Wed, 18 Feb

  Human Error Investigation Program - Effective Implementation / 

  Virtual Event

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  18 Feb 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Event

  Faculty: Dr. Ginette Collazo
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  12 days to the event

  Wed, 18 Feb

  Inspection Close-Out, Enforcement Risk, and Long-Term FDA Relationship Management / 

  Virtual Event

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  18 Feb 2026, 11:00 am – 1:00 pm GMT-5

  Virtual Event

  Faculty: Charles H. Paul
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  13 days to the event

  Thu, 19 Feb

  Cybersecurity Expectations for GxP Systems / 

  Virtual Event

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  19 Feb 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Event

  Carolyn Troiano
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  14 days to the event

  Fri, 20 Feb

  FDA Inspection Readiness: Building a Defensible State of Control Before the Investigator Arrives (1) / 

  Virtual Event

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  20 Feb 2026, 11:00 am – 1:00 pm GMT-5

  Virtual Event

  Faculty: Charles H. Paul
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  17 days to the event

  Mon, 23 Feb

  FDA Inspections After QMSR: What Replaces QSIT 2.0 - The New Inspection Reality / 

  Virtual Event

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  23 Feb 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Event

  John E. Lincoln
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  18 days to the event

  Tue, 24 Feb

  Process Validation Requirements and Compliance Strategies / 

  Virtual Event

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  24 Feb 2026, 11:00 am – 12:00 pm GMT-5

  Virtual Event

  José Mora
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  19 days to the event

  Wed, 25 Feb

  Analytical Method Validation under Good Laboratory Practices (GLPs) / 

  Virtual Event

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  25 Feb 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Event

  Faculty: Dr. John C. Fetzer‎
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  20 days to the event

  Thu, 26 Feb

  Calculations for Process and Product Capability / 

  Virtual Event

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  26 Feb 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Event

  Faculty: Elaine Eisenbeisz
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  This Webinar is Available in Recording

  Batch Record Review and Product Release / 

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  This Webinar is Available in Recording

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  Faculty: Danielle DeLucy
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  This Webinar is Available in Recording

  CSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See / 

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  This Webinar is Available in Recording

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  Faculty: Carolyn Troiano
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  This Webinar is Available in Recording

  FDA Labeling and UDI Essentials for Medical Products / 

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  This Webinar is Available in Recording

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  Faculty: José Mora
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  This Webinar is Available in Recording

  Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities / 

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  This Webinar is Available in Recording

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  Faculty: Charles H. Paul
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  This Webinar is Available in Recording

  FDA Registration, Listing & Facility Licensing - Common Pitfalls and Best Practices / 

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  This Webinar is Available in Recording

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  Faculty: Meredith Crabtree
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  This Webinar is Available in Recording

  Bad Standard Operating Procedures (SOPs) – Bad Training: Garbage In, Garbage Out / 

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  This Webinar is Available in Recording

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  Faculty: Michael Esposito