Event Catalog
Browse 71 professional development events
ChatGPT-Assisted Technical Writing
Learn practical, compliant approaches to using ChatGPT for SOP drafting, document development, and technical writing in regulated industries.
Charles H. Paul
Excel Spreadsheets — Ensuring Data Integrity and 21 CFR Part 11 Compliance
Avoid FDA 483s by properly configuring GxP-compliant Excel spreadsheets — step-by-step setup of audit trails, security features, Part 11 compliance, and minimal-documentation validation.
David NettletonThe CSA Playbook for SaaS, PaaS & Modern Digital Platforms — 3-Hour Course
A 3-hour CSA playbook for SaaS and PaaS validation — learn to evaluate vendor evidence, interpret SOC reports, separate responsibility, and build FDA-defensible documentation.
Carolyn TroianoPart 11, Data Integrity & Documentation for SaaS/PaaS Validation — 3-Hour Course
A 3-hour deep dive into 21 CFR Part 11 and data integrity for SaaS/PaaS cloud systems — covering audit trails, shared responsibility, change management, and FDA inspection readiness.
Carolyn Troiano
Human Error and Documentation Practices in Good Laboratory Practices (GLP)
Navigate human error, documentation pitfalls, and GLP requirements — learn how accurate record-keeping supports data integrity, research reproducibility, and regulatory compliance.
Charles H. Paul
Bad Standard Operating Procedures (SOPs) — Bad Training: Garbage In, Garbage Out — 3-Hour Course
Fix bad SOPs at the source — a 3-hour course covering SOP writing parameters, training development, curriculum design, LMS considerations, and ongoing knowledge retention assessment.
Michael EspositoProject Management Best Practices for Computer Systems Regulated by FDA
Apply project management best practices to FDA-regulated computer system implementations — covering SDLC, CSV, GAMP V, roles, documentation, and maintaining systems in a validated state.
Carolyn Troiano
Step-by-Step Process for Successful Sterility Failure Investigations
A step-by-step guide to investigating sterility test failures — covering FDA regulations, root cause tools, lot impact assessment, and audit-ready documentation.
Danielle DeLucy
Beyond Digital Batch Records: Managing FDA and EU GMP Documentation While Preserving Data Integrity
Learn how digital/electronic DHF, DMR, DHR, and EU MDR Technical Documentation improves data integrity, reduces human error, and simplifies global regulatory compliance.
John E. Lincoln
Measuring SOP Effectiveness Across Training, Qualification, GMP Operations, and AI-assisted environments
Learn how to measure and improve SOP effectiveness across training, qualification, GMP operations, and AI-assisted environments — connecting documentation, compliance, and workforce performance.
Michael EspositoGMP 101 and Inspection Readiness
Establish the mindset for modern GMP compliance — understand how FDA inspects, why documentation gaps become findings, and how to build inspection-ready systems.
Charles H. PaulData Integrity and Documentation Excellence
Go beyond theory — understand how ALCOA+ appears in real records, how Part 11 applies to electronic systems, and how to design documentation that withstands audits.
Charles H. PaulThe FDA Medical Device File (DHF, DMR, DHR, Market Authorizations) and EU MDR Technical Documentation
Navigate FDA DHF, DMR, DHR, and EU MDR Technical Documentation requirements — understand the similarities, differences, and how to align global medical device documentation.
John E. LincolnGood Clinical Practices (GCP) Audit and Inspection Readiness
Build GCP audit and inspection readiness — cover QMS, SOPs, documentation, internal audits, and personnel training to ensure compliant clinical trial execution.
Charles H. Paul