Video Library
GMP topic-based playlists to support practical learning.
21 CFR part 11
21 CFR Part 11 governs the use of electronic records and electronic signatures in FDA-regulated industries, focusing on system validation, access control, audit trails, data integrity, and electronic signature controls.
Watch PlaylistData Integrity
Data Integrity in GMP ensures that data generated, processed, and stored are reliable and attributable, legible, contemporaneous, original, and accurate (ALCOA+), enabling sound decision-making and regulatory compliance.
Watch Playlist21 CFR part 820
21 CFR Part 820 outlines FDA quality system requirements for medical devices, emphasizing risk-based quality management, design controls, process validation, documentation, audits, and continuous improvement to ensure device safety and effectiveness.
Watch PlaylistHeating, Ventilation, and Air Conditioning in GMP
HVAC systems in GMP facilities are critical for maintaining controlled environments by managing temperature, humidity, air cleanliness, and pressure differentials. Properly designed, validated, and monitored HVAC systems help prevent contamination, support product quality, and ensure compliance with regulatory requirements in pharmaceutical and medical device manufacturing.
Watch Playlist21 CFR part 211
21 CFR Part 211 establishes the FDA’s current Good Manufacturing Practice (cGMP) requirements for finished pharmaceutical products, covering quality management, facilities, equipment, production controls, laboratory testing, documentation, and distribution to ensure medicines are safe, effective, and consistently manufactured.
Watch PlaylistSterile Manufacturing
Sterile manufacturing involves the production of aseptic pharmaceutical products under strictly controlled conditions, using validated processes, cleanrooms, environmental monitoring, and contamination control strategies to ensure products are free from viable and non-viable contaminants and meet regulatory and patient safety requirements.
Watch PlaylistComputer System Validation
Computer System Validation (CSV) ensures that computerized systems used in GMP-regulated activities are fit for their intended use, operate consistently, and maintain data integrity, through a documented, risk-based lifecycle approach aligned with regulatory requirements.
Watch PlaylistCleaning Validation
Cleaning validation provides documented evidence that cleaning procedures effectively and consistently remove product residues, cleaning agents, and contaminants from manufacturing equipment, ensuring product quality, patient safety, and compliance with GMP requirements.
Watch Playlist21 CFR part 111
21 CFR Part 111 establishes the FDA’s current Good Manufacturing Practice (cGMP) requirements for dietary supplements, covering personnel, facilities, production controls, testing, documentation, and quality systems to ensure supplements are manufactured, packaged, labeled, and held to meet quality and safety standards.
Watch PlaylistRoot Cause Analysis Tools
Root Cause Analysis tools are structured methods used to identify and analyze the underlying causes of deviations, failures, or non-conformances in GMP environments, supporting effective investigations and the development of meaningful corrective and preventive actions (CAPA).
Watch PlaylistInspections and Audits
Inspections and audits are systematic evaluations of facilities, systems, processes, and records to verify compliance with regulatory and GMP requirements, identify gaps, and ensure continual improvement in quality and regulatory readiness.
Watch Playlist