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GMP, GAMP® & Validation Training > Understanding Corrective and Preventive Action Systems (CAPA) Training Course


Understanding Corrective and Preventive Action Systems (CAPA) Training Course

Course Title:Understanding Corrective and Preventive Action Systems (CAPA) Training Course
Course Delivery:

The Understanding Corrective and Preventive Action Systems (CAPA) Training Course can be delivered in a hotel, one of our offices, your premises or online via a virtual classroom. The course content can be tailored to meet your requirements. Request a quote for an onsite course or an online virtual classroom course for an agreed number of delegates from your site.

Course Duration:1 day
Course Overview:

ITS’ Understanding Corrective and Preventive Action Systems (CAPA) Training Course provides an understanding of how to run effective Corrective and Preventive Action (CAPA) systems that will benefit your business and satisfy the regulators.

The CAPA training course covers areas that can cause confusion including terms, definitions, deviations, non-conformances and use of corrections, corrective and preventive actions.

Course activities include applying the CAPA system and root cause analysis to a potential real case scenario.

Course Content:
  • Investigate what a CAPA system is
    • Terms, acronyms and their application
    • What is CAPA and why is there so much emphasis on the use of CAPA in the regulated industry?
    • How utilising the Global Harmonization Task Force’s structured approach to CAPA can help cure problems
    • How the overall approach of CAPA is meant to work, including the links to change control
  • Consider regular misconceptions of CAPA systems, and misinterpretation of terms
    • If a corrective action is instigated then there must be preventive action implemented … or not?
    • The use of the terms corrections, corrective actions and preventive actions
  • Reflect on regulatory expectations
    • Regulatory requirements
    • Review common system and human failings that have a negative effect on CAPA and the business
    • Common FDA and EU regulator inspection findings including FDA warning letters
  • Investigate use of root cause analysis to determine needs for a correction, corrective action and what may be a preventive action
    • Review of different methods such as Cause and Effect, Flow and Process Charts, Mind Mapping
    • Utilise risk management techniques
    • Documenting CAPA activities
  • Investigate the subject of Human Error
    • Review human characteristics and factors that could play a role in human error
    • Identify different types of human failure
    • Review ways of addressing human failure
  • Apply and review CAPA case studies to enhance course learning
    • Identify potential deviations and what needs to be done
    • Use different potential real activities to apply CAPA
  • Review learning and summarise effective CAPA systems
    • Personal reflection and group summary of how to define effective CAPA systems


Open Course Dates:
Understanding Corrective and Preventive Action Systems (CAPA) Training Course
23 April 2021, Online Virtual Classroom Delivery, £577+VAT per learner.
Understanding Corrective and Preventive Action Systems (CAPA) Training Course
9 July 2021, Near Manchester Airport, £577+VAT per learner.
Understanding Corrective and Preventive Action Systems (CAPA) Training Course
8 October 2021, Newcastle, £577+VAT per learner.
 
 

GROUP BOOKING DISCOUNT - Book more than one place on an open course and receive the following discounts:

  • 10% discount on second place
  • 20% discount on third place
  • 25% discount on fourth place

Group booking discounts cannot be used in conjunction with any other offer.

Cost includes tuition, lunch and training materials. Download a printable version of the Booking Form and Terms and Conditions.

Onsite Courses:

This course can be delivered to a group of up to 12 delegates at your premises or as an online virtual classroom course for an agreed number of delegates from your site. Request a quote.

Testimonials:

“Course content was excellent and the handouts will be useful for future reference.”
Forest Tasara Ltd

“The training is very comprehensive and training material is presented in a clear and concise manner.”
Forest Tasara Ltd

“Well organised.”
Coloplast Hungary Ltd

“It will be very useful in the future.”
Coloplast Hungary Ltd

“Useful and good training with a very helpful trainer.”
Coloplast Hungary Ltd

“Good job! Well done!”
Coloplast Hungary Ltd

“Very good.”
Coloplast Hungary Ltd

“It was really useful to hear these topics in a well-structured way.”
Coloplast Hungary Ltd

“The training was very useful.”
Coloplast Hungary Ltd

ITS Tutor's Experience:

ITS’ Regulatory Compliance Trainer, Dr Jennifer Thompson, has over 20 years of experience in the pharmaceutical sector in computer systems validation and IT infrastructure controls and compliance and has delivered projects for a wide range of companies in the UK, EU and USA including GlaxoSmithKline, Novartis Healthcare, Lonza Biologics, Elan Pharmaceuticals, Hoffman LaRoche and others. Her experience covers computerised systems used in manufacturing, laboratories, enterprise systems and clinical trials management. She has written articles and given presentations on a wide range of topics and contributed to the GAMP® Good Practice Guide “A Risk-based Approach to GxP Process Control Systems” and “The Risk Based Compliance Handbook” by Siegfried Schmitt (Paraxel).

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Further Information:
Request more information on this training course.



Course Calendar:


 


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For further information, please contact
our team on +44 (0)1642 222232 or
email enquiries@its-ltd.co.uk