Тематический план

  • Introduction to Pharmaceutical Validation Training

    This series of four virtual instructor-led bite-size courses (approximately two hours each) provides anyone new to the topic of validation with an overview of four core areas: cleaning, analytical, process and equipment, and facilities, utilities and qualification.


    Course Code FBE-060
    Region

    UK and Internationally

    Delivery e-Learning
    Role Role: All-roles
    Competence Functional and Behavioural
    Sector Sector: Pharmaceuticals

    This Course is Aimed at

    This training is an ideal introduction to validation for people who are new to the subject and are directly involved in or responsible for validation.

    Overview

    Pharmaceutical validation has been a regulatory requirement for nearly 40 years and continues to attract significant regulatory attention. As well as the obvious benefits of compliance, validation also offers significant business advantages because well understood, capable and controlled processes form the basis of day-to-day manufacturing and testing operations.

    Programme Content and Key Areas

    Each two-hour virtual course provides an overview of the relevant guidance for each validation area and takes you through an interactive session where you will learn:

    • Cleaning: How to design your cleaning process, analytical methods and specifications to be used during cleaning validation as well as how to maintain the validated state
    • Analytical: Method verification, method validation, system suitability and method transfer
    • Process: The principle of validation, the validation lifecycle, quality by design, execution of process validation and continuous process verification
    • Equipment, facilities and utilities: The different stages of qualification from the URS to the performance qualification and how they should be executed

    Each course uses scenarios and interactivity to support and strengthen the learnings.

    The four bite-size courses, along with the computer systems validation eLearning, form a good foundation for anyone wanting to gain a good understanding of validation in the pharmaceutical industry.

    Learning Outcomes

    By the end of the courses you will understand:

    • The current regulatory expectations relating to:
      • Analytical validation
      • Equipment, facilities and utilities qualification
      • Process validation
      • Cleaning validation
    • Validation documentation requirements
    • How each of the validation disciplines should be executed at your workplace
    • Validation maintenance requirements

    To book now contact us.

       

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