Good Documentation Practice and Record Keeping Regulations (FDA & EMA) Seminar training classes conferences & workshops presented by ComplianceOnline register for training on FindaSeminar.com

Home

Add your seminars

Training Calendar Creator Seminar Venues Training Provider Directory
 

New Seminar Search:  

 

Helpful links

find similar training...
Search by state...
Customer Support


Do you need help finding the right class, date, or location or other assistance?

Request information about upcoming training seminars workshops and conferences in   and other cities listed on FindaSeminar.com Submit a support request and receive a prompt reply.

We guarantee this ComplianceOnline training seminar

We are an authorized partner of ComplianceOnline

 

Price protection. The price to attend Good Documentation Practice and Record Keeping Regulations (FDA & EMA) is set by the training providerThere is no added charge for our services.

We honor most training provider coupons
*.   Call  a representative to see if your discount coupon applies.


Privacy. Your personal information won't be shared with anyone but the training provider ComplianceOnline.


Security. When you register for this seminar on FindaSeminar.com your personal data and payment information is safely collected and processed using secure SSL encryption technology.

Flexibility. FindaSeminar.com offers you three ways to register for Good Documentation Practice and Record Keeping Regulations (FDA & EMA) seminar by ComplianceOnline.
Register online, by phone (800) 349-1935,or fax (800) 712-5569
Who should attend Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
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
Reviews
Write and read ComplianceOnline reviews and reviews about the training seminar Good Documentation Practice and Record Keeping Regulations (FDA & EMA) on the Seminar News Network and the Training News Network.
 

Frequently asked questions and registration options for the training seminar Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

 
Find Training Near You
Use our clickable map to find training near you
Use Our Clickmap
 
hotel seminars meeting space directory
hotel meeting space training facilities restaurant and lodging

 
 
 

request on site training details for the Good Documentation Practice and Record Keeping Regulations (FDA & EMA) seminarRequest on site training

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

 Email information about this seminar Good Documentation Practice and Record Keeping Regulations (FDA & EMA) by ComplianceOnline to yourself your manager or associatesEmail this event... View and register for other training seminars like Good Documentation Practice and Record Keeping Regulations (FDA & EMA) by ComplianceOnline on FindaSeminar.com See similar training.. Find and register for other training seminars by ComplianceOnline on FindaSeminar.com Other seminars from ComplianceOnline

By:

training seminars by ComplianceOnline ComplianceOnline   

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:   

see Registration info for seminar cost, group discount etc.

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)

 
 
 

 Seminar / Training class dates & locations

 

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search


 

 
 

print the agenda print agenda for the Good Documentation Practice and Record Keeping Regulations (FDA & EMA) seminar

 

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)

print this agenda print agenda for the Good Documentation Practice and Record Keeping Regulations (FDA & EMA) training seminar

 view dates and locations for this seminar

 

 
 
 ComplianceOnline training and seminar course catalog

Click any title to view upcoming ComplianceOnline training event dates and locations, class syllabus and other seminar details

 

     
 

 
     

 

  Also try the advanced seminar search tool

   FindaSeminar HomeComputer Training

unix training
training classes

 © 2002-2018 FindaSeminar.com™ All Rights Reserved.  Terms of Use |  Privacy Policy |  Training News Network