GMP & GDP Online Course - What is Data Integrity

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Opleiderscore: starstarstarstarstar_half 9,2 Pharmaceutical Consultancy Services (PCS) heeft een gemiddelde beoordeling van 9,2 (uit 5 ervaringen)

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Beschrijving

This course allows employees to quickly learn in a fun and interactive way what Data Integrity is, why it is so important, what could go wrong, what they should do to comply to the Data Integrity standards (including ALCOA and understanding what raw data is), and how Quality Culture relates to the level of Data Integrity.

  •  Explain what Data Integrity is and why it's so important
  •  Understand the expectations of ALCOA in Good Documentation Practice (GDocP)
  •  Relate your own behavior to Data Integrity expectations

Introduction

Data Integrity is worldwide a hot topic at the moment. There has been a significant rise in issuance of warning letters by the US Food and Drug Administration …

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This course allows employees to quickly learn in a fun and interactive way what Data Integrity is, why it is so important, what could go wrong, what they should do to comply to the Data Integrity standards (including ALCOA and understanding what raw data is), and how Quality Culture relates to the level of Data Integrity.

  •  Explain what Data Integrity is and why it's so important
  •  Understand the expectations of ALCOA in Good Documentation Practice (GDocP)
  •  Relate your own behavior to Data Integrity expectations

Introduction

Data Integrity is worldwide a hot topic at the moment. There has been a significant rise in issuance of warning letters by the US Food and Drug Administration (US FDA) and the trend continues even now. Inspectors expect to see a solid policy on how to handle data, both for written documents and digital systems. As pharmaceutical employee, you need to understand the principles of Data Integrity, and how data is best recorded. ALCOA is recognized by national authorities as a tool to clarify the expectations in Good Documentation Practices, also known as GDocP. This course allows new employees to quickly learn in a fun and interactive way how to fill in documentation, and making corrections using the ALCOA tool.

Why you should follow this course

PCS has organized GMP & GDP training since 1990. That's 30 years of training experience! PCS translates all these years of experience into an interactive and fun way of learning about the GMP's and GDP's online!

  • Experienced expert trainers
  • Internationally recognized official training certificate
  • Easy & fun ways of learning about the GMP and GDP
  • Each course ends in an exam, testing your knowledge

PCS - The Practical Compliance Specialists since 1990

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