GDP Pharma supply chain deviation and CAPA management

Specifications

 Type: classroom

 Duration: 8 hours

 Language : NL - EN

 Proof: Certificate from our academy (after successfully completing the exam)


PLEASE NOTE: Our certificates are valid for 2 years. You must have completed your training again before the expiry date.

classroom training schedule

Objective


Despite all preparations, sometimes unforeseen problems arise. In the pharmaceutical industry, you are expected to investigate why errors occur and how to prevent them in the future.


Good research is not easy. Often a root-cause analysis is time-consuming and it is a challenge to get to the real cause. Common challenges here are:

  1. What are good corrective and preventive measures?
  2. How do I make sure nothing is overlooked?
  3. How can I check timelines?


These are just a few examples of the challenges encountered in daily practice when implementing deviation management.


Deviation management helps improve quality, but can cause unnecessary loss of time and frustration in many companies. It doesn't have to be this way!


In this training you will learn what the expectations are from the GDP guidelines regarding Deviations and CAPA management. Also the creation of clear workflows is discussed, but also how good impact assessments and root-cause research can be performed.


Determining effective corrective and preventive actions (CAPAs) with realistic timelines and preventing exceedance of these timelines is also discussed in detail.


GDP training ensures that the quality of pharmaceutical products is maintained throughout the supply chain, from the manufacturer to the end user. It focuses on proper distribution practices, storage conditions and transportation methods to prevent contamination, mix-ups and damage.


GDP training is essential to improve the skills required for efficient pharmaceutical distribution. Learn to implement Good Distribution Practice (GDP) standards to ensure regulatory compliance and maintain high quality assurance.

Target audience

Quality managers, operations coordinators and transport managers



Experience

Basic knowledge of GDP guidelines required.

Please consult our training offer for the appropriate training.




Contents

  • Full details regarding setting up and monitoring deviations and CAPAs.
  • Certain methodologies supporting research
  • Qualitative completion and monitoring of surveys.
  • Exam (80% minimum result) this training

Result

  • Effective use of resources and less frustration
  • Deviations are really resolved through proper research and the use of the correct CAPAs
  • Increased compliance level
  • Continuous improvement of your processes (focus pharma)
  • Certificate from our academy (after successfully completing the exam)



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