Good Documentation Practice and Record Keeping Regulations (FDA & EMA) training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)  

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For:

Anybody who works in a regulated environment, Manufacturing & Production Personnel / Managers, Research and Development Personnel (R&D) / Managers, Quality Assurance & Quality Control Personnel / Managers, Laboratory Personnel / Managers

Cost:   

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Seminar Summary:

This one-day workshop covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation. (see full course description)

 

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Training Course Syllabus:


Course Description

Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This one-day workshop covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations and warning letters for different points presented in the session. In several occasions, group activities will be presented to find errors in documents based on the information provided in the class.

Learning Objectives:

In this seminar you will gain a basic to moderate knowledge of definition, purpose, importance of GDP, General rules of GDP, GDP as applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029> introduction "Good Documentation Guidelines", A very brief introduction to European Union (EU) GDP, and finally its enforcement along with some observation samples from FDA.

Areas Covered:

Definition, Purpose, and Importance
General Rules and Principles of GDP
Requirements of Records
General Tips in GDP:
Signature / initial and the meaning
Copying records
Document maintenance
Recording the time and date
Correction of errors
Rounding rules
Back dating
Missing data
Voiding / cancelling records
Recreating / rewriting records
Deviations
General Tips for Laboratory Notebook Documentation:
Assignment of Lab notebook
How to properly document in lab notebooks
How to include tables / graphs
How to attach instrument print outs
How to include metadata
How to reference lab notebook
How to store the completed lab notebooks
US Pharmacopoeia General Chapter <1029>
Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)
What is new in the Latest Version?
Outline of EU GDP Regulations
GDP Enforcement (examples from FDA warning letters)

DAY 01(8:30 AM - 4:30 PM)

08:30 am – 08:59 am : Registration and Meet & Greet.
09:00 am – 11:00 am
Seminar objectives review, expectations and scope.
Definition of GDP
Purpose of GDP
Importance of GDP
Requirements of records
General rules of GDP:
Signature / initial and the meaning
Copying records
Document maintenance
Recording the time and date
Correction of errors
Rounding rules
Back dating
Missing data
Voiding / cancelling records
Recreating / rewriting records
Deviations
11:00 am – 12:00 pm
General Tips for Laboratory Notebook Documentation
Assignment of Lab notebook
How to properly document in lab notebooks
How to include tables / graphs
How to attach instrument print outs
How to include metadata
How to reference lab notebook
How to store the completed lab notebooks
12:00 pm - 01:00 pm Lunch
01:00 pm – 02:00 pm
US Pharmacopeia General Chapter <1029> introduction “Good Documentation Guidelines”
History of the Chapter
The purpose of the Chapter
Outline of the Chapter
Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)
History of the Regulation in the EU
The 2011 Update
The list of changes in the 2011 update
Outline of the EU GDP guideline
Discussion into the guideline
02:00 pm – 03:00 pm
GDP Enforcement
How to avoid getting warning letters
Examples from FDA warning letters
03:00 pm - 04:00 pm 21 CFR 11 (electronic records and electronic signatures)
04:00 pm - 04:30 pm Question & Answer session

Seminar Summary:

This one-day workshop covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation. (see full course description)

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