Event Catalog
Browse 71 professional development events
HPLC Analytical Method Development and Validation
Master HPLC instrument and method validation to meet US EPA and FDA requirements for pharmaceutical analysis.
Dr. John C. Fetzer
Analytical Lifecycle Management Under ICH Q14 and Q2(R2): What Changes Operationally
Understand the operational impact of ICH Q14 and Q2(R2) on analytical method development, validation, transfer, and lifecycle management in regulated pharmaceutical environments.
Meredith Crabtree
Onboarding In A GMP Environment — Best Practices
Build a compliant and effective GMP onboarding program — cover training coordination, contractor vs. employee differences, and how to reduce the compliance learning curve.
Michael Esposito
Drug Master Files (DMFs) — Understanding and Meeting Your Global Regulatory and Processing Responsibilities
Master Drug Master File creation, submission, and lifecycle management — navigate FDA and EMA requirements, protect proprietary information, and maintain global regulatory compliance.
Charles H. PaulBad 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 EspositoHow to Conduct Annual Product Reviews to Achieve GMP Compliance
Learn how to write compliant Annual Product Quality Reviews (APRs) — covering regulatory requirements, what to include, and how well-written APRs strengthen your compliance position.
Danielle DeLucyHuman Error Investigation Program — Effective Implementation
Implement a proven human error investigation methodology — classify error categories, identify root causes, develop effective CAPA, and apply Human Factors to prevent recurring GMP issues.
Dr. Ginette CollazoAnalytical Method Validation under Good Laboratory Practices (GLPs)
Master analytical method validation under GLP — covering statistical requirements, selectivity, stability assessment, reagent comparison, and FDA compliance for pharmaceutical laboratories.
Dr. John C. Fetzer
Deviation Backlog Reduction: Balancing Investigation Depth, Closure Speed, and Justifiable Decisions
Practical strategies for reducing pharmaceutical deviation backlogs without sacrificing investigation quality — covering risk-based depth, defensible closure, CAPA, and inspection readiness.
Charles H. Paul
OTC Monograph Reform and OMUFA II: What FDA's Modernized OTC Framework Means for Manufacturers
Understand the practical impact of FDA's modernized OTC monograph system and OMUFA II obligations on daily regulatory, quality, manufacturing, and compliance decisions.
Meredith Crabtree
Nitrosamines After the Initial Assessment: When Does a Change Trigger Reassessment and How Should Impact Be Evaluated
Master the complex decisions that follow post-approval changes — when nitrosamine reassessment is mandatory, when scientific rationale suffices, and how to evaluate NDSRI impact using CPCA under ICH M7.
G. SundarMeasuring 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 Esposito
Using EU GMP Annex 22 as the Framework for Governing AI Systems, Validation Traceability, and Data Integrity Controls
Learn how to apply EU GMP Annex 22 as a practical framework for AI system governance, validation traceability, lifecycle management, and data integrity controls in regulated pharmaceutical and biotech environments.
Charles H. Paul
Packaging and Labeling Controls: Reducing Hidden Errors Before They Escalate
Understand how to reduce hidden packaging and labeling errors in pharmaceutical manufacturing — covering proactive controls, AI-driven process improvements, and supply chain performance strategies.
Michael EspositoSuccessfully Investigating Deviations
Master the fundamental steps of deviation investigation — use objective evidence to determine root cause, develop effective CAPA, and avoid FDA 483 observations.
Danielle DeLucy