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This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
Gaylord National Resort & Convention Center
201 Waterfront Street
National Harbor, Maryland, USA, 20745
Hotel Reservations: +1 877-382-7299
This course has been updated to include the new revised GAMP® 5 Second Edition. This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
Gaylord National Resort & Convention Center
201 Waterfront Street
National Harbor, Maryland, USA, 20745
Hotel Reservations: +1 877-382-7299
This classroom course has been updated to include the new revised GAMP® 5 Second Edition as well as a fundamental discussion on framing the application of AI/ML in regulated spaces.
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements.
Gaylord National Resort & Convention Center
201 Waterfront Street
National Harbor, Maryland, USA, 20745
Hotel Reservations: +1 877-382-7299
This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
Gaylord National Resort & Convention Center
201 Waterfront Street
National Harbor, Maryland, USA, 20745
Hotel Reservations: +1 877-382-7299
This training course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer.
Topics include control system alarm management, common system construction deficiencies, GMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
This training course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.
This training course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and GMP inspection preparation, and provides guidance on advanced asset lifecycle management strategy.