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Good Documentation Practice in GMP and GDP

1 Day
GMP, GDP

This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations for Good Documentation Practice. The course aims to provide you with the guidance and tools to understand and implement the Good Documentation in the context of GDP and GMP.

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Audience

Anyone interested in Good Documentation Practice requirements

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
Price
€ 699

per participant    (excl. VAT)

✓ Exclusive learning approach

✓ Personal course documentation

Lunch, water, coffee & tea

Networking

✓ Course certificate after completion

Location

Quastion Learning Center (Qplus consult BVBA)

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

Your Trainer

Kristina Bindus

  • Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.

  • Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.

  • Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.

  • Kristina is specialized in online medical communication: webcast, webinar and e-learning.

  • She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.

  • Kristina has an extensive experience in Quality & Pharmacovigilance.

Program

Introduction

  • Why is good documentation practice important?

  • Legal framework

  • Responsibilities within organization

Basic Principles

  • Basic principles which should always be applied

  • Do’s and don’ts

Learn Which Activities Need to be Recorded and Retained

  • Overview of activities which should be recorded for GMP and GDP activities

 

How to establish a Document Management Process

  • Objective

  • Requirements

  • Practical approach and roll-out within organization

Documents Access and Security

  • Guidance on paper documents​

  • Requirements to electronically managed documents

Document Creation, Review and Approval​​​

  • Rules on document creation

  • Review of documents

  • Approval of documents

Document Modification

  • How to modify documents, what is acceptable and what is not

Handwritten Entries

  • Allowed or not?

  • When allowed, how to proceed

Copies of Documents

  • How to replicate documents

  • Controlled and uncontrolled?

  • Do’s and don’ts

Document Maintenance

  • Who is responsible?

Inspectorate Expectations to Document Management Process

  • ​​​​Inspectorate expectations to Document Management process​

  • Industry best practices

Participants about this course:
Contact Quastion for more information about this Good Documentation Practice in GMP and GDP training.
 
Other courses you might be interested in:

On demand

Good Quality Management Practice in GMP/GDP

1 Day

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+32 (0) 2 899 05 68

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Leuvensesteenweg 643 bus 7

1930 Zaventem

Belgium

TAV: BE 0822 940 179

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a division of

Qplus consult BV

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