Quality: Documentation
High-level overview of quality event management principles and practices.
Part 2 of the ISPE Quality Training Series
This course provides a high-level overview of essential quality documentation practices and SOPs. Rather than focusing solely on completing individual forms, this course explains why elements such as SOPs, batch records, change control forms, and supporting documentation are critical to a robust pharmaceutical quality system. You’ll learn the key principles behind effective document creation, control, and lifecycle management, ensuring you understand their role in maintaining compliance and operational excellence.
Learning Objectives
By the end of this course, participants will be able to:
- Explain the role of quality documentation within a regulated pharmaceutical environment, including its impact on compliance, traceability, and data integrity.
- Apply core documentation principles, including ALCOA+ concepts, to ensure accuracy, completeness, and reliability of quality records.
- Demonstrate an understanding of document lifecycle management, from creation and approval through revision, archival, and retrieval.
- Evaluate the impact of change control on documentation and ensure updates are appropriately assessed, approved, and implemented.
- Strengthen inspection of readiness by ensuring documentation practices consistently support regulatory expectations and audit requirements.
Course Modules
This course includes the following modules:
- Regulated Environments
- Core Principles of Quality Records
- Managing the Lifecycle
- Change Control and Documentation Impact
- Document Issuance and Version Control
- Archival, Retention, and Retrieval of Quality Documentation
- Quality in Action – Learning Through Scenarios
- Documentation: Training, Qualification, and Compliance
- Documentation: The Backbone of Quality Systems
Who Should Attend
This course is ideal for:
- Quality Assurance (QA) and Quality Control (QC) professionals responsible for creating, reviewing, or approving quality documentation
- Manufacturing, operations, and technical staff who generate or execute GMP records and procedures
- Regulatory affairs and compliance professionals supporting documentation standards and inspection readiness
- Personnel responsible for document control, data governance, and records management systems
- New or developing professionals seeking foundational knowledge of GMP documentation practices and data integrity principles
Registration Fee
| Member | Nonmember |
|---|---|
| US$270 | US$300 |
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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View upcoming courses