Overview: This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, efficacy and/or data integrity. Key components of documentation and record management system will be introduced. Regulatory requirements will also be discussed as the basis of documentation standards. It will also cover different types of records and how it would affect quality systems.
Why Should You Attend: Documents are part of Quality Management System to record the information pertaining to a study or process. It demonstrates the integrity of the data collected. Most of the observations are based on poor documentation practices, thus the work can’t be reconstructed nor defended in an inspection. This session will cover the regulatory requirements of documentation and record management system.
Areas Covered in the Session:
Key factors of Documentation and Record Management
Regulatory Expectations to Documentation
Review of Warning Letters and Observations
Types of Records in the pharmaceutical laboratories
Fundamentals of Good Documentation Practices
Who Will Benefit:
Quality Assurance scientists
Pharmaceutical development and manufacturing personnel
Manufacturers of raw materials and excipients
Contract laboratory Organization personnel.
Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003.