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A Beginner's Guide to Process Validation
  • A Beginner's Guide to Process Validation

    This module focuses on the practical applications of the lifecycle approach to all stages of Process Validation (PV). It provides  insight into regulations guidance, and best practices around PV utilized across the industry.​



    • The lifecycle approach of Process validation ​

    • Requirements of FDA 2011 and EU 2014 and 2016 guidance on process validation with emphasis on 2015 EU GMP Annex 15​

    • The practical expectations for a three-stage approach​

    • Process design, equipment and process qualification -  ongoing/continued process verification​

    • Process Validation/Process Performance Qualification (PV/PPQ)- Protocol - acceptance criteria and report ​

    • Continued Process Verification-maintaining a state of control over the product lifecycle​

    • Why it matters

      Lifecycle Process Validation (PV) remains one of the most important, yet, commonly misunderstood topics in the pharmaceutical industry.  Application of science and risk-based approach to validation can deliver business efficiency and increased reliability, while  enabling robust processes and assuring product quality.​

    • Who is it for​ ​

      This course is ideal for technical and managerial personnel responsible for facility, utility, and equipment qualification and process validation. It Is also relevant to quality assurance (QA) personnel.​

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