Creating and Maintaining Effective Documentation in the FDA Regulated Environment
Overview:
FDA expects a manufacturer to create and maintain “effective” documentation. What does that mean? In this course, we will examine the ideas associated with creation, maintenance, and control of quality systems documentation. cGMP documentation practices will be reviewed to ensure that required documentation is clear, complete, and easy to understand. Attendees will learn techniques to ensure that all records and procedures are created, reviewed, and implemented in a controlled manner and uniform format. “Good documentation practices” will be reviewed.
Instructional methods include: Lecture, discussion, use of examples/handouts
How You Will Benefit:
By the end of the course, participants will have gained:
- The regulatory requirements for documentation
- Basic techniques for ‘controlling’ documentation
- How to write an effective SOP/Procedure/Work Instruction and how to create an effective Form
- How to maintain good documentation practices
Course Topics:
- Regulatory Requirements
- GMPs for drugs, biologics, devices
- Practical requirements & expectations
- How do we “establish” documentation control?
- How do we “maintain” documentation control?
- Is it OK to deviate from our SOPs?
- Document Control Pitfalls – Common Problems and Some Solutions
- Writing an effective SOP/Procedure/Work Instruction
- Creating an effective Form
- How do I know my documents are effective?
- Good documentation practices
Who Should Attend:
Anyone who is responsible for writing or maintaining technical or regulated documentation. This includes engineering, laboratory, manufacturing, QA/RA, and documentation services employees especially. This course will also be of value for anyone who uses technical or regulated documents.