Implementing Good Documentation Practices
Agenda: Day One
I. Explore Documentation for GxP Compliance: A Compliance Perspective
- Describe GMP history and discuss the evolution to GxPs
- Identify regulatory expectations for GxP documentation
- Define the different types of GxP documents
- Understand what a risk assessment involves and why it is important
- Describe industry standard documentation hierarchies
- Identify the importance of organization structure and how it relates to roles and responsibilities
Exercise: Define Types of Documentation and Where They Fit in a Documentation Hierarchy
II. Improve GxP Documentation Practices
- Develop standards for preparing documentation and establishing the document structure
- Outline guidelines for reviewing and correcting documentation
- Analyze challenges and solutions for improving the review and approval processes
- Develop strategies to revise existing documentation
- Perform risk assessments to improve documentation
Exercise: Review a Sample Document and Identify Present Errors
III. Author Compliant GxP Documents
- Determine what level of detail to include in key GxP Procedural Documentation:
- Policies, SOPs and guidelines
- Protocols, batch records and test methods
- Laboratory notebooks and logbooks
- Write clear and concise documents that are user-friendly
- Apply best practice tips for content, format, style, presentation, distribution and executive summaries
- Examine information mapping and team input
- Avoid pitfalls and minimize unacceptable GxP procedural documentation
Exercise: Create a Process Map and Author an Effective SOP
IV. Assess GxP Regulations and the EU Regulatory Environment
- Review predicate rules for GxP documentation details
- Identify EU regulations and guidances related to documentation
- Prepare for a documentation audit
- Determine what to look for, how much to look for and how to review cGMP documentation
- Adopt a global approach for compliance with documentation requirements
Exercise: Use Techniques Acquired in Class to Review Sample Documents for Good Documentation Practices
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.