Training & Events

Essential elements of a robust data integrity program, documentation requirements to ensure compliance, the development of quality systems that support data integrity and compliance with the Canadian GMP and FDA cGMP., staff training and development to support the implementation of data integrity program, all using interactive discussions, case studies, and current industry examples.

Course Deliverables

The main topics will include:
• Presentation of tools that can be used to approach product testing, batch record review, auditing and investigations  differently - to identify data integrity risks or gaps
• Techniques for the development of critical thinking in the quality unit
• Proper handling of laboratory results and data, and common bad practices that can compromise compliance and the  integrity of the data obtained
• Participants will learn the importance of developing and fostering a corporate culture that supports compliance,  designed with patient safety in mind, while meeting the expectations of regulators
• The essential elements of a data integrity program will be discussed, including hands on practice and risk  assessments
• Discussion of the most current regulatory approaches to data integrity,

Class participants will receive industry specific examples to support topics discussed, including the review of FDA warning letters, and citations from other regulatory agencies. Discussions will involve evaluation of scenarios for data integrity gaps, conducting risk assessments and how to mitigate risk. Tips on how to approach the development of data integrity program, where to start and how to ensure the most important areas are addressed first. Tips and tools for preparing for your upcoming regulatory inspection or audit, will be covered. Participants will be asked to send specific data integrity questions to the instructor in advance of the course by email to nicole.schepp@compliantapproach.com.