GAMP®

  • Practical Application of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems (T11)
    This highly interactive classroom workshop gives participants hands-on experience in applying practical techniques and solutions to solve computerized systems compliance challenges. Participants will discuss and analyze case studies, apply newly acquired knowledge to hypothetical case-study systems, and have the opportunity to discuss their own real-life challenges with other participants and an expert trainer. Participants should come prepared to work in groups to devise workable and creative solutions to realistic problems and case study scenarios, facilitated by the instructor. Immediately apply the course learning objectives using the electronic download of the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized....
  • GAMP® Part 11 Training Course (T08)
    Updates to this course include: Recently announced FDA Part 11 Inspection Assignments EU regulatory expectations as reflected in the draft revised Annex 11 This course is also available online: Online Course: Complying with Part 11 – Risk Management Using the GAMP® Guide: Records and Data Integrity as a resource, this course will give participants a practical introduction to the 21 CFR Part 11 regulation, which affects all aspects of computerized systems in the pharmaceutical industry and up-to-the-minute information on current FDA interpretations. Taught through classroom presentations, workshop sessions, and team exercises, the course will present an overview of Part 11....
  • GAMP® Basic Principles Training Course (T07)
    This classroom course has been updated to include the new revised EU GMP Annex 11 , and an overview of 21 CFR Part 11 . This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical 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. The course does not aim to cover detailed and highly technical aspects....
  • GAMP 5®, Annex 11/Part 11 Basic Principles Training Course (T45)
    This Classroom training course has been updated to include the new revised EU GMP Annex 11 , and an update on 21 CFR Part 11 . This three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical 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. The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles....
  • GAMP® 5 GxP Process Control Training Course (T21)
    This highly interactive classroom course describes how the GAMP® 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.....
  • GAMP® Data Integrity 21 CFR Part 11 Training Course (T50)
    The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity , electronic records and signatures, and the compliant operation of GxP....
Subscribe to GAMP®