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Good Manufacturing Practices (GMPs) are regulations that describe the methods, equipment, facilities, and controls required for producing safe and effective pharmaceutical and biotech products. Regulators expect the companies to have continuous training program in place and to demonstrate the effectiveness of the training delivered. Non-compliance with GMPs can be expensive, time-consuming and can result in FDA regulatory action imposed against your firm. This one and a half a day refresher training course presents an overview of the framework and principles of GMPs, by reviewing the background and history of GMPs and defining roles and responsibilities of those affected by the requirements. In addition, this course provides insights on how to design a GMP-compliant system, and how best to comply with requirements governing component control, warehousing, storage and distribution operations. In completion of this participants will be able to implement proven validation solutions and identify current regulatory enforcement trends. They will also be able to evaluate proven strategies for implementing GMPs in preparation for an FDA inspection. - Identify recent changes in GMP-related regulations, requirements, and guidances - Identify recent trends in related compliance activities that have been published by regulatory agencies - Select key issues and problems from particular Warning Letters and compliance activities of interest - Identify examples and cases that emphasize the importance of quality systems and GMP thinking A one and a half day course covering GMP essentials including: - History of US GMPs - International Regulatory Authorities and Regulations - Regulations and Guidelines - Personnel and Organization - Buildings, Facilities, and Utilities - Equipment - Materials Management and Supplier Controls - Manufacturing and Packaging - Labels and Labeling - Laboratories and Testing - Storage and Distribution - Records and Documentation - Risk Management - Validation - Quality Management Systems - Change Management - US FDA Inspectional Process Interactive Group Exercise: - Mapping your process to GMPs to ensure compliance