GMP Fundamentals Bundle Series - Limited Offer

CAPA / RCA / Investigations Training Course

CAPA / RCA / Investigations Training Course (T73)

Coming Soon 2024

Overview

CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity. Through lecture and “hands-on” team exercises this course illustrates how a mature Pharmaceutical Quality System utilizes CAPA and Continuous Improvement, how to effectively write and investigate to achieve holistic CAPA, and what PPPQMS can do for your PQS.

Learning Objectives:

ICH Q10, ICH Q7, 21CFR 211 regulatory framework and linkage to the Pharmaceutical Quality System

Understanding the importance of how CAPA and Continuous Improvement integrate with the Pharmaceutical Quality System

Understanding Quality System Management Maturity

  • Where and how does Management Responsibility fit in
  • What are the enablers of a Pharmaceutical Quality System and how they work

How to Perform Holistic and Effective Correction and CAPA

  • Effective Deviation Authoring
  • Investigation for True Root Cause
  • Correction and CAPA

Product Performance and Product Quality Monitoring System (PPPQMS)

  • Product & Process Understanding & Tools​
  • ​Monitoring and Continual Improvement

ICH Q10 Pharmaceutical Quality System

View Dates


What You Will Learn

  • To author an effective investigation
  • Perform holistic correction and CAPA
  • Reduce deviations through risk based continuous improvement

Resources and Activities


Who Should Attend

  • Quality Assurance
  • Tech Support
  • Tech transfer functions
  • Operations functions
  • Early career (3-5 years within the industry)
  • Qualified persons in Europe
  • Team Lead/Operator/Technician Staff
  • Managers
  • Section heads
  • Supervisors and CEOs
  • President
  • Owner or General Manager working in pharmaceutical and biotech manufacturing (not CMO)
  • Engineering
  • Architecture or construction
  • Service provider or consulting
  • Equipment or material supplier

Additional Course Information

Communities of Practice

This training course is of particular interest to existing and future members of the Regulatory and Quality Networking Communities.


Daily Schedule and Pricing

  • online-live
    Online Live
    20 - 21 Mar 2024

    Daily Schedule at a Glance

    Training course times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.

    0830 – 0845 Login
    0845 - 0900 Introductions
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1300 Lunch
    1300 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Wrap-up, Questions, Discussion 
    0830 – 0845 Login
    0845 - 0900 Recap
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1300 Lunch
    1300 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Wrap-up, Questions, Discussion 

    Registration Fee

    REGULAR
    Member US$ 1,785.00
    Nonmember   US$ 2,085.00
    Government / Academia / Emerging Economies* US$ 550.00
    Student* US$ 90.00
    *ISPE Membership is required for these registration rates.

    Now Your Whole Team Can Participate in an ISPE Learning Experience

    • 3 - 5 participants - Save 10%
    • 6 - or more participants - Save 20%

    Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.


    Cancellations/Refunds

    Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.