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
Agenda: Day Two
V. Examine Electronic Data Management and 21 CFR Part 11 Compliance
- Interpret 21 CFR Part 11 requirements relating to electronic records and documentation
- Identify electronic signature needs
- Examine EU regulations relating to electronic records
- Outline EDMS tools and functionality
- Analyze common computer systems managed by EDM systems
Exercise: Address Obstacles and Common Deficiencies
VI. Examine Documentation Monitoring and Alterations
- Describe the basic elements of change control
- Address the five major deficiencies associated with change control:
- No procedure
- Inadequate procedure
- Procedures not followed
- Inadequate documentation/evaluation
- Poor documentation management
- Prepare for a documentation audit
- Improve ability to review and audit documents
Exercise: Case Study – Define Deficiencies of Change Control and Identify Areas for Improvement
VII. Examine Amendments and Respond to Deviations
- Describe planned and unplanned deviations
- Examine techniques for capturing amendments and deviations
- Analyze objectivity vs. subjectivity in formulating conclusions
- Devise methods for safeguarding accuracy of review practices
- Determine the root cause of non-compliance
- Prepare recommendations for corrective actions
- Implement timeframes and secure sufficient corrective action plans
VIII. Execute Successful Audits and Improve Audit Report Writing Practices
- Identify key benefits of successful audits
- Describe audit phases and different types of audit reports
- Assess the impact of what is stated in the exit interview and how to document that in the audit report
- Write reports that are value-added and important to yield corrective action(s)
- Conduct audit follow-up of corrective procedures to yield effective audit close-out
Exercise: Review a Sample Audit Report
IX. Avoid Common Barriers to Success
- Outline recent documentation related issues
- Identify current FDA trigger points – hot topics
- Determine where to go for more information – helpful references
Exercise: Examine Common Pitfalls and Identify Proven Solutions
Apply Here
Powered by Fast Secure Contact Form
