BioNetwork Course: Good Documentation Practices and Data Integrity

Are you responsible for preserving documents or for ensuring that your company’s data is complete and correct?

Stay on top of your field by learning the regulatory requirements and best practices for pharmaceutical documents, documentation, and record keeping.

In this course, we review the differences between documents and records, and we talk about the typical ISO 9001 document hierarchy. We also explain each document level. Participants study record keeping requirements, including the electronic signature and other regulations in 21 CFR Part 11. Plus, we answer questions about the appropriateness and qualification of Excel spreadsheets for record keeping.

Finally, we review general good documentation practices incorporating the requirements in FDA’s Guidance to Industry “Data Integrity and Compliance with cGMP.”

Topics Include

This one-day, eight-hour course covers the following topics:

• GMP Documents
• GMP Records
• Document Control
• Good Documentation Practices
• 21 CFR Part 211
• Electronic Records
• Qualifying Excel Spreadsheets
• Data Integrity
• Medicines & Healthcare Products Regulatory Agency

Learning Objectives

• Define and distinguish pharmaceutical documents and records.
• Detail the regulatory requirements, functional purpose, and typical industrial uses of each document type.
• Review 21 CFR 11 requirements and resultant impacts on electronic signatures and record keeping.
• Present emerging regulatory expectations for data handling and data integrity assurance (good documentation practices).

Audience

This course equips any employee who writes, edits, or compiles documents used in manufacturing FDA regulated products, including:

• Pharmaceutical Production Associates
• Production Managers
• Quality Managers
• Management