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Good Clinical Practice (2-day)


This course is designed for those working in clinical trials, who require certification and CPD. It provides an introduction to the clinical trial process and the requirements of Good Clinical Practice (GCP), and goes on to cover each section of ICH-GCP so that participants become familiar with all the guidance. The practical requirements around running a trial to GCP standard will also be covered.


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Good Clinical Practice and Clinical Trials Introduction (1-day)


This course is designed for those who currently work in a GMP environment, particularly the QP, who may need to understand about clinical trials and how they are run. It provides an introduction to the requirements of Good Clinical Practice (GCP), walking through the clinical trials process from start to finish, with a focus on the ethical/ regulatory/documentation requirements as well as the practical aspects of clinical trials. Practical exercises will help bring into focus the logistics involved in running a clinical trial.


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Good Manufacturing Practice (1-day)


This course examines why we have Good Manufacturing Practice (GMP), its legal status and the key GMP issues surrounding pharmaceutical manufacture such as documentation, training and facilities.


This popular course introduces the EU Guide to GMP and considers its implementation in the modern pharmaceutical regulatory environment.


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Good Manufacturing Practice (3-day)


This stimulating course systematically builds up the knowledge of delegates over 3 intensive days. It covers the regulations and guidelines associated with GMPs and the expectations of the MHRA and FDA. Topics examined cover incoming materials, including control of suppliers of APIs, excipients and packaging materials. Other sessions examine manufacturing, packaging, premises, equipment, engineering activities, quality systems and laboratory practices. The course is highly interactive and also features several real-life case studies.


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