Good Documentation Practices
The FDA requires organizations to plan, implement, and maintain processes and procedures to keep consumers safe from foodborne illness. Establishing and maintaining a well-functioning documentation system for this plan can be a big challenge for businesses. Documentation provides legal evidence that you and your employees are following the practices and procedures that are deemed necessary for safety. This course reviews good documentation practices (GDPs), including the do’s and don’ts of creating records, document control, common errors, and key characteristics of GDPs.
Learning objectives:
Recognize common mistakes made in documentation
Explain what good documentation practices are
Identify commonly used documents
Utilize measures for document control
Outline
1. Introduction
a. Housekeeping
b. Class agenda and objectives
c. Real life applicability
d. Introduction
2. Regulatory standards
a. CGMP compliance
b. Establishing procedures
3. Types of documents
a. Document Hierarchy
b. Doc description
c. Quality manual
d. Procedures
e. Work Instructions
f. MPRs
g. BPRs
4. Record keeping requirements for CGMPs
a. Equipment cleaning and use logs
b. Receiving records
c. Lot production and control records
d. Laboratory records
e. Distribution records
f. Complain files
5. Group activity: Handwashing SOP critique
6. Document control
a. Requirements
b. Benefits of documents and records
7. Good documentation practices
a. Legibility
b. Alterations
c. Templates and doc logs
d. Avoiding Common Pitfalls
e. Key Characteristics
f. Why documentation is important
g. Key characteristics of GDPs
h. Common Errors
i. Group activity: Practice finding errors in documentation
j. Correction example
k. Documentation do’s and don’ts
l. Raw Data
m. Falsification
n. Signatures
o. Data entry
8. Group Activity: Documentation do’s and don’ts review
9. Electronic records
a. Electronic signatures
b. System controls
c. Data audit trail
d. Open systems
10. Questions and feedback