Good Documentation Practices and Data Integrity

Date(s)
  • April 12, 2017
Day(s)
  • Wednesday
Times
  • 8:00 AM to 5:00 PM
Location
Raleigh
Building
BTEC
Room
120
Format
Face-to-Face

This course presents the regulatory requirements and best practices for pharmaceutical documents, documentation, and record keeping. Topics covered will include: a review of the differences between documents and records; the typical ISO 9001 document hierarchy as well as an explanation and appropriate content of each document level; record keeping requirements including the electronic signature and record keeping requirements of 21 CFR Part 11; and the appropriateness and qualification of Excel spreadsheets for record keeping. General good documentation practices incorporating the requirements detailed in FDA's Guidance to Industry "“Data Integrity and Compliance With cGMP” are also reviewed.

Level: Beginner
Lab Hours: 0.00
Lecture Hours: 8.00
Total Contact Hours: 8.00
$100.00
Register
Course ID: 170999
Instructor: Richard Boeh
Class is Full
Cancelled