Pharmaceutical Quality: QRM, CAPA & Root Cause Analysis

    TBC 2021, online training

    Summary

    This unique online training course is designed for pharmaceutical quality professionals. Delegates will examine Root Cause Analysis(RCA) techniques by applying them to practical examples from the industry. Learn how to meet Corrective Action Preventive Action (CAPA) audit expectations and to maintain control over product and processes in a GMP environment.

    Who should attend?

    QA Managers and Inspectors, QC Laboratory Managers, Qualified Persons, Regulatory Compliance Managers, Production Managers, Formulators, Process Validation and Scale-up Specialists, Process Development Managers, Regulatory Compliance Managers, Chemical Engineers

    Key Topics

    • Application of Quality Risk Management (QRM)
    • Regulatory Requirements for RCA, CAPA and OOS
    • Causal Analysis: Definition of different types of cause
    • RCA techniques, concepts and stages
    • Data acquisition and Task analysis
    • Principles of Critical Deviation Management (CDM)
    • CAPA Audit expectations
    • Training, re-training and Human Error

    Programme

    • All training materials provided in digital form
    • All delegates will receive digital and LinkedIn certificates
    • CAPA is the pharmaceutical process which outlines how to undertake activities to maintain control over product and processes in a GMP environment
    • Without a thorough understanding of CAPA, and the accompanying need for RCA, companies will spend a lot of time and effort in repeatedly correcting faults rather than establishing procedures that will prevent these faults from occurring

    Trainers

    Generapharm, CEO
    Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities.
    Online Participation
    1 450 Price incl. VAT: 1 450

    Price per delegate including:

    Online participation

    Online workbook & materials

    Certificate

    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    Lydia Makori

    l.makori@symmetric.events
    +421 222 200 543