GMP Lead Auditor

    GMP Lead Auditor

    19 – 20 March 2024, live online training


    This course gives you a 2-day full training about GMP audits. You will not only get the basics about the jobs and tasks on both sides of a GMP auditors (as the auditor and as the auditee), but you will also face several examples directly from practice. These examples will be presented to you by the trainer and then you have plenty of time to discuss them in small groups. How would you react? What is the best behavior? What are the best follow-ups. With this interactive course you will not only broaden your experiences, but you will also have a very interactive exchange with the participants and learn about different opinions and different strategies.

    This course also covers the topics risk orientated planning, problem solving strategies, the fast and effective execution of audits, the classification of audit findings and communication strategies for audits.

    Learning Objectives

    • Experience exchange with the other participants on a multicultural platform
    • Examples from real audits with workshops and role play
    • Audit finding classification systems
    • Smart strategies for the planning and execution of audits
    • Strategies for problem solving
    • Communication strategies
    • Trouble shooting
    • Knowledge tests
    • Workshops
    • Break-Out sessions with real audit examples

    Key Topics

    • Regulatory background (EU-GMP Guideline, CFR, ICH, EMA, FDA guidance and the PIC/S)
    • ISO19011
    • Practical examples from real audits
    • Risk oriented planning
    • Audit plans, check lists and reports
    • Classification of audit findings
    • CAPA-plans
    • Management of difficult situations
    • Experience exchange
    • Cultural differences
    • Problem solving strategies
    • Communication strategies for audits

    Who should attend?

    Everyone who is concerned with GxP audits, for example: GMP Auditors, QA Professionals, CMO and CLO Managers and Representatives, Manufacturing Experts, Quality Control Experts, Regulatory Affairs Managers, Validation Experts, Supply Chain Managers, Sales Representatives, IT Managers in the fields of GxP, EHS Managers.

    The course is designed for beginners, advanced expert GMP auditors.

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post-training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 7 days
    • Training in digital format
    • Digital and LinkedIn certificates


    quality, biotech, biologics, regulatory
    Dr. Felix Tobias Kern is the Associate Director - Head of Compliance Launch and Technology Center at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology.
    GMP Lead Auditor

    GMP Lead Auditor

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    Online Participation
    1 650  Price incl. VAT: 1 650 
    Equivalent of approx. 1 849 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate

    Price per delegate including:

    Online participation

    Online workbook & materials


    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.

    pharma learning leader

    Lydia Makori
    +421 222 200 543

    Training Details
    • Start Date
      19. March 2024
      09:00 AM Vienna time
      08:00 AM London time
      04:00 AM New York time
      01:00 AM Los Angeles time
    • End Date
      20. March 2024
    What participants said about Symmetric courses

    "I was happily pleased with the enormous experience of the trainer, i enjoyed it a lot and learned a lot."
    Senior Development Pharmacist, Orion Corporation

    "Keep up the excellent standard of training courses!"
    FDF Industrialisation Manager, Medichem Manufacturing

    "I have received a lot of knowledge that will be of big use for my profession."
    Quality manager, Vironova AB

    "Thank you for a very informative training course. The timing of start/break/finish was perfect."
    Clinical Project Manager, Regen Lab

    "Would highly recommend this course, great practical insights throughout helped to make it all very real, many thanks."
    Head of API and Contract Manufacturing, Zentiva Group

    "Very informative and memorable training course for me."
    Quality Vice President, Darou Pakhsh

    "The trainer was very knowledgeable about the topics and was able to answer all questions."
    Drug Product Subject Matter Expert, Pfizer