Validation

  • Process Validation Training Course (T46)
    Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should I make? Are we taking enough samples? Do we need to use statistics in our protocols? The real question may be: am I even focusing on the right questions? Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry. This classroom course is relevant to individuals working throughout the pharmaceutical product lifecycle in....
  • GAMPĀ® 5 GxP Process Control Training Course (T21)
    This highly interactive classroom course describes how the GAMPĀ® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems , may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a lifecycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP 5 may be practically applied to process control systems. The course covers both regulated company and supplier quality management systems and the full system life cycle from concept to retirement.....
  • Process Validation in Biotechnology Manufacturing (T32)
    The inherent complexity and uncertainty of biotechnology make developing and validating bioprocesses for manufacturing proteins and biopharmaceuticals very difficult. Understanding and using FDA's Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products. This classroom course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses . In addition, the course identifies the long list of activities required to validate biopharmaceutical processes. Topics include a comprehensive strategy to process validation; a review of important biotechnology manufacturing processes,....
Subscribe to Validation