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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.
Audience
Anyone interested in Good Documentation Practice requirements
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
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
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Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.
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Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.
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Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.
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Kristina is specialized in online medical communication: webcast, webinar and e-learning.
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She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.
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Kristina has an extensive experience in Quality & Pharmacovigilance.
- Kristina Bindus has over 25 years of experience in QA, RA, Auditing and Pharmacovigilance within leading (bio)pharmaceutical and medical devices companies.
Program
Introduction
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Why is good documentation practice important?
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Legal framework
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Responsibilities within organization
Basic Principles
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Basic principles which should always be applied
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Do’s and don’ts
Learn Which Activities Need to be Recorded and Retained
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Overview of activities which should be recorded for GMP and GDP activities
How to establish a Document Management Process
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Objective
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Requirements
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Practical approach and roll-out within organization
Documents Access and Security
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Guidance on paper documents
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Requirements to electronically managed documents
Document Creation, Review and Approval
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Rules on document creation
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Review of documents
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Approval of documents
Document Modification
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How to modify documents, what is acceptable and what is not
Handwritten Entries
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Allowed or not?
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When allowed, how to proceed
Copies of Documents
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How to replicate documents
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Controlled and uncontrolled?
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Do’s and don’ts
Document Maintenance
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Who is responsible?
Inspectorate Expectations to Document Management Process
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Inspectorate expectations to Document Management process
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Industry best practices
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Good Documentation Practice in GMP and GDP
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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