{"id":55194,"date":"2023-03-27T12:03:18","date_gmt":"2023-03-27T10:03:18","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/2-day-training-for-pharma-4-0-a-different-way-to-approach-gxp-products-systems-and-compliance-with-fda-april-13-14-2023-researchandmarkets-com\/"},"modified":"2023-03-27T12:03:18","modified_gmt":"2023-03-27T10:03:18","slug":"2-day-training-for-pharma-4-0-a-different-way-to-approach-gxp-products-systems-and-compliance-with-fda-april-13-14-2023-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/2-day-training-for-pharma-4-0-a-different-way-to-approach-gxp-products-systems-and-compliance-with-fda-april-13-14-2023-researchandmarkets-com\/","title":{"rendered":"2 Day Training for Pharma 4.0: A Different Way to Approach GxP Products, Systems, and Compliance with FDA – April 13-14, 2023 – ResearchAndMarkets.com"},"content":{"rendered":"
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DUBLIN–(BUSINESS WIRE)–The “Pharma 4.0: A Different Way to Approach GxP Products, Systems, and Compliance with FDA”<\/a> training has been added to ResearchAndMarkets.com’s<\/strong> offering.\n<\/p>\n

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\nFDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.\n<\/p>\n

\nThese include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.\n<\/p>\n

\nSo, what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far? The FDA is embarking on a modernization program to update their technology and processes for working with industry to assure regulated products meet FDA compliance.\n<\/p>\n

\nThere are numerous programs underway, including partnerships with other agencies and industry to move forward as technology continues to improve. The FDA plans to take advantage of these technologies, just as industry is focused on the same goal.\n<\/p>\n

\nThe key is making sure these are employed in a way that promotes public health, providing more improved FDA-regulated products with fewer negative side effects and issues. Plans will also enable FDA to work with industry to move products to market faster, further improving public health.\n<\/p>\n

\nPharma 4.0 provides an operating model for FDA-regulated products. It embeds health regulations best practices in the model.\n<\/p>\n

\nWe will explore the best practices and strategic approach for evaluating the current processes involved in assuring computer systems used in the conduct FDA-regulated activities are modernized and streamlined. Cloud computing, automated computer system testing and mobile devices are just part of the mix we can expect to explode in the near term.\n<\/p>\n

\nFinally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.\n<\/p>\n

\nTraining Overview<\/strong>\n<\/p>\n

\nComputer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and\/or report data.\n<\/p>\n

\nElectronic records and electronic signatures (ER\/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER\/ES capability in systems used in an FDA-regulated environment.\n<\/p>\n

\nIn the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk.\n<\/p>\n

\nThe level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process.\n<\/p>\n

\nSystem size, complexity, business criticality, GAMP 5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.\n<\/p>\n

\nWhy Should You Attend<\/strong>\n<\/p>\n

\nThis webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).\n<\/p>\n

\nFunctions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, regulatory affairs and submissions, adverse events management, and post-marketing surveillance.\n<\/p>\n

\nThe program will provide you with a current snapshot of the state of industry and FDA as both forge ahead in the face of ever-changing technology.\n<\/p>\n

\nKey Topics Covered:<\/strong>\n<\/p>\n