Why Are Good Documentation Practices So Important?
$695.00 – $1,390.00
The primary purpose of this program is to explain why Good Documentation Practices are so important and to cover the entire documentation process. Based on research and best practices, “Why Are Good Documentation Practices So Important? is a program that provides an in-depth description of the elements that make up Good Documentation practices to satisfy the GMP Regulations.
This program consists of six modules that can be presented together or as standalone units. The six modules include:
- Why Document?
- What are Good Documentation Practices?
- Meaning of Signature
- Documentation Roles
- Documentation Basics
- Correcting Documentation Errors
At the end of this program participants will be able to:
- Describe why documents are written.
- Describe why documents are so important.
- Identify some key documents related to medical device and pharmaceutical manufacturing.
- Recognize to whom GDPs apply.
- Identify regulatory agencies that monitor GDPs.
- Define Good Documentation Practices.
- Identify key questions to ask when recording raw data.
- List 5 documents that require GDP.
- Match document categories with their definition.
- Match 3 enforcement actions with their definition.
- Identify facility inspection outcomes.
- Identify the meaning of your signature.
- State who must register their signature.
- List 3 reasons why initials are used on documents.
- State when to re-register your signature and initials.
- List the two major responsibilities of a Performer.
- List the key function of the Verifier.
- Identify other functions of the Verifier.
- List the key function of the Approver.
- Identify other functions of the Approver.
- Identify six documentation basics
- Recognize and express time in both military and meridian time formats.
- Express duration in appropriate formats.
- Describe when it is appropriate to pre or postdate documents.
- Express dates in two formats.
- Express decimals in appropriate formats.
- Round numbers.
- Describe the use of “N/A” and ditto marks.
- Identify the major rule related to correcting errors.
- Identify who is responsible for correcting errors.
- Identify 5 major error correction basics.
- Explain how to handle missing data.
- Describe 4 key steps to correcting an error.
- Identify 5 typical correction notations.
- Describe what to include in a correction notation.
- Describe how to handle a notation when there is little white space.
- Explain how to handle errors in approved or controlled documents.
The program may be presented in six standalone modules or as one day-long training session. Presented as standalone modules, the series will take approximately 12 hours; presented as a day-long training program it will take approximately 6 to 8 hours.
Standalone Program—6 Meeting Series Modules. Each module consists of 4 documents:
- Leader’s Guide
- Trainee Handout
- Assessment Answer Key
- DVD: Two narrators lead participants through the program. Estimated time 30 minutes
- Leader’s Guide
- Trainee Workbook
- Video Script
- Knowledge Assessment
- Knowledge Assessment Answer Key
Program available for distribution on company website. See License Type below for details.
Click on the link below to see a demo of this program.
Single Use (Play on 1 Computer or use DVD Player and Monitor) ($695), Network/Plant Wide (WMV Files for Use on Shared Drive) (+$695.00)