GMP Training Programs
Structured GMP training designed for regulated industries.
Pharmaceutical Out of Specification (OOS) Management
This specialized training provides a comprehensive understanding of the handling Out of Specification (OOS) results in GMP-regulated environments. It covers regulatory expectations (FDA 21 CFR Part 211, EU GMP), the OOS investigation lifecycle, root cause analysis, retesting/re-sampling criteria, and how to distinguish OOS from Out of Trend (OOT) and aberrant results. The training equips participants with actionable tools to conduct effective, timely, and inspection-ready OOS investigations while ensuring data integrity and product quality.
PremiumPharmaceutical Change Control Management Training
This training equips pharmaceutical professionals with knowledge and tools to manage changes in a GMP-regulated environment systematically and compliantly. Participants will learn how to evaluate, document, implement, and verify changes across systems, processes, equipment, and documents without compromising product quality or regulatory compliance. Aligned with FDA (21 CFR Part 211), EU GMP Annex 15, ICH Q10, and WHO GMP, this course emphasizes risk-based change assessment, impact evaluation, and cross-functional change coordination.
PremiumDeviation Management Training
This focused training equips pharmaceutical professionals with the tools and knowledge to identify, document, investigate, and close deviations effectively in a GMP-regulated environment. Participants will learn regulatory expectations, root cause analysis techniques, CAPA integration, and risk-based approaches to deviation handling. The course emphasizes a structured, data-driven approach to deviation management in line with FDA 21 CFR Parts 210/211, EU GMP, and ICH Q10, helping ensure product quality and inspection readiness.
PremiumPharmaceutical CAPA Management Training
This training program delivers an in-depth understanding of Corrective and Preventive Action (CAPA) systems as critical components of pharmaceutical quality management. It guides participants through the systematic handling of quality issues—from root cause identification to sustainable corrective and preventive solutions. Aligned with FDA (21 CFR Part 211), EU GMP, ICH Q10, and ISO 13485 (for medical devices), this course provides practical tools, templates, and real-case exercises to implement a robust, inspection-ready CAPA program.
PremiumHuman Error – The Leading Cause of GMP Failure
This training addresses human error as the primary root cause of deviations, non-conformances, and regulatory citations in GMP-regulated industries. It provides a systematic approach to understanding, analyzing, and preventing human error using behavioral science, process improvement, and error-proofing techniques. Participants will learn how to identify error-prone tasks, implement preventive measures, and integrate error reduction strategies into the Quality Management System (QMS) to enhance operational excellence and regulatory compliance.
PremiumData Integrity for Chromatographic Systems
This training provides a specialized focus on data integrity requirements for chromatographic systems (HPLC, GC, UPLC, IC, etc.) used in GMP-regulated quality control laboratories. It aligns with FDA 21 CFR Part 11, EU GMP Annex 11, WHO TRS 996 Annex 5, MHRA GxP Data Integrity Guidance, and PIC/S PI 041, emphasizing ALCOA+ principles for electronic and hybrid data. Participants will learn how to ensure compliance in chromatography data acquisition, processing, review, approval, and storage — with a focus on preventing data manipulation, ensuring secure audit trails, and maintaining traceability from raw data to final reports.
PremiumDocumentation Management Training
This focused training equips pharmaceutical professionals with the tools and knowledge to identify, document, investigate, and close deviations effectively in a GMP-regulated environment. Participants will learn regulatory expectations, root cause analysis techniques, CAPA integration, and risk-based approaches to deviation handling. The course emphasizes a structured, data-driven approach to deviation management in line with FDA 21 CFR Parts 210/211, EU GMP, and ICH Q10, helping ensure product quality and inspection readiness.
PremiumQuality Management System
This comprehensive training is designed to provide pharmaceutical professionals with an in-depth understanding of Quality Management Systems (QMS) aligned with global regulatory expectations (FDA, EU GMP, ICH Q10). The course focuses on principles, elements, and implementation strategies essential for maintaining a compliant and efficient QMS in a GMP-regulated environment.
PremiumGood Documentation Practice (ALCOA+)
This training provides a comprehensive understanding of Good Documentation Practice (GDP) and its critical role in maintaining data integrity in GMP-regulated environments. It is based on ALCOA+ principles — ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available — as required by FDA, EU GMP, WHO, PIC/S, and MHRA guidelines. Participants will learn how to apply GDP in paper-based, hybrid, and electronic systems, integrate GDP into Quality Management System (QMS) processes, and avoid common documentation errors that lead to regulatory findings.
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