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How To Keep A CGMP Compliant

Laboratory Notebook

ABOUT THE COURSE

“How To Keep a CGMP Compliant Laboratory Notebook” is a half-day course designed to review the critical skills and knowledge required for maintaining laboratory notebooks in regulated and non-regulated environments. The course materials are developed from current best documentation practices in the pharmaceutical and related industry laboratories. The course is augmented with practical exercises which will be conducted by the students. This is an excellent means to introduce new personnel, regardless of their specialization to the concepts of good laboratory documentation practices.  

WHO SHOULD ATTEND

All newly hired laboratory personnel or QA who are preparing to work in a CGMP regulated laboratory will benefit from this course. Also, personnel who are in need of a review of laboratory documentation practices will also benefit from this course.  

COURSE OUTLINE

1.      A History of the Laboratory Notebook

2.      Types of Data Captured in Laboratory Notebooks

3.      Types of Laboratory Notebooks

4.       Issuance, Review, Control, Retention and Archival

5.       Laboratory Data Entry and Documentation Best Practices

6.       Practical Exercises

7.       Summary

8.      Questions and Answers

 
ADMINISTRATION

The course is one day in length. Cost is $525 per person, with a ten-student minimum for on-site presentation. Payment can be made by personal check, company check, purchase order, or by MasterCard, Visa, or American Express. Registration can be made on-line or via telephone.

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