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GxP/GMP regulations are required to be used in regulated industrie s such as food and beverages\, pharmaceutical\, medical devices\, and cosm etics. GMP regulations describe required quality management system for pro duction and testing of products in these regulated industries. The purpose of the GMP regulations is to ensure that a product is safe and meets its intended use.
\n\nQuality management system ensures that a product i s safe and meets its intended use. Quality management system has four main components: quality planning\, quality assurance\, quality control\, and quality improvement.
\n\nQuality audit is the process of systematic inspection of quality management system which is carried out by an interna l or external auditor or an audit team. It is an important part of organiz ation'\;s quality management system and is the major part of GxP/GMP re gulations.
\n\nCAPA - Corrective and Preventive Action plan. It is r equired for FDA compliance in case of specification situations or other de viations.
\n\nDocumentation is a critical tool for ensuring GxP/GMP compliance.
\n\nIn the regulated environment which must be GxP/GMP c ompliant\, document control is the cornerstone of the quality system. It i s so important that if an external audit identifies deficiencies in the do cument control system\, the entire organization can be shut down.
\n\n< p>There are also GMP requirements for information technology. For a drug t o be produced in a GxP/GMP compliant manner\, some specific information te chnology practices must be followed. Computer systems involved in the deve lopment\, manufacture\, and sale of regulated product must meet certain re quirements.\n\nChange control within quality management systems (QM S) and information technology (IT) systems is a formal process used to ens ure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries\, manufactures are requir ed to use a change control procedure.
\n\nIn this seminar\, you will learn the framework of GxP/GMP regulations\, quality management system\, quality audit\, and CAPA.
\n\nYou will also learn the connection bet ween GxP/GMP and document control\, details of document control procedures and the role of Quality Assurance in the documentation systems.
\n\nThis seminar also includes very important GMP requirements for informatio n technology and how computer systems including documentation management s ystems must meet GxP/GMP requirements. There is also a review of change co ntrol procedure and how it should be used in GxP/GMP environment.
\n\n< p>GMP regulations require that all documentation be issued\, managed\, and controlled using a document management system. This seminar also includes information about few major document management systems.\n\nGxP/GMP is about Quality Management S ystem (QMS) where an organization needs to demonstrate its ability to cons istently provide product that meets customer and applicable statutory and regulatory requirements.
\n\nThere are few types of quality audits. One of them is GMP audit. GMP audit is very important and critical for an organization in a regulated industry. The preparations for the audit shoul d be done properly before the audit. The primary objective of the audit is to demonstrate the compliance with GxP/GMP regulations.
\n\nIn the regulated environment which must be GxP/GMP compliant\, document control i s the cornerstone of the quality system. It is so important that if an ext ernal audit identifies deficiencies in the document control system\, the e ntire organization can be shut down.
\n\nDocumentation is the key to GMP compliance and ensures traceability of all development\, manufacturin g\, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product.
\n\nWhat is quality management system? Are you ready for t he audit?
\n\nLearn about GxP/GMP regulations and how they affect qu ality management system and quality audit. Learn about different types of quality audits and how to properly prepare for them\, what actions you nee d to take to ensure that your organization will pass an audit.
\n\nD o you know how to properly manage and control your documentation so that y our organization can pass GMP audit? Are your IT systems GxP/GMP compliant ?
\n\nLearn how to manage and control documents as well as IT system s in compliance with GxP/GMP requirements and be able to pass quality audi t.
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