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  FDA’s 21 CFR Part 11 Add-on Inspections / 

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  Faculty: John E. Lincoln
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  Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements / 

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  The US FDA QMSR Transition - 21 CFR 820 and ISO 13485 / 

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  Faculty: John E. Lincoln
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  The FDA Inspection from SOP to 483 / 

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  How to conduct Annual Product Reviews to achieve GMP Compliance / 

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  Faculty: Danielle DeLucy
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  Project Management Best Practices for Computer Systems Regulated by FDA / 

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  Faculty: Charles Paul
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  The CSA Playbook for SaaS, PaaS & Modern Digital Platforms - 3-Hour Course / 

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  Faculty: Carolyn Troiano
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  Excel Spreadsheets – Ensuring Data Integrity and 21 CFR Part 11 Compliance / 

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  Faculty: David Nettleton
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  How to Validate Automated Pipelines Under CSA - 3-Hour Course / 

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  Faculty: Carolyn Troiano
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  Part 11, Data Integrity & Documentation for SaaS/PaaS Validation - 3-Hour Course / 

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  Faculty: Carolyn Troiano
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  Statistical Process Control (SPC) and Control Charts for Laboratory Compliance / 

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  Design of Experiments 101 – Methods and Analysis / 

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  Faculty: Elaine Eisenbeisz
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  The FDA Medical Device File (DHF, DMR, DHR, Market Authorizations) and EU MDR Technical Documentation / 

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  Faculty: John E. Lincoln
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  Good Clinical Practices (GCP) Audit and Inspection Readiness / 

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  Faculty: Charles H. Paul
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  Quality Metrics & KPIs: How to Measure What the FDA Actually Cares About / 

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  Batch Record Review and Product Release / 

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  Faculty: Danielle DeLucy