Data integrity is a cornerstone of quality assurance in any regulated industry. Reliable data is crucial for making informed decisions, ensuring compliance, and protecting patient safety. Unmanaged and inaccurate data can lead to severe consequences, including compromised product quality, regulatory non-compliance, and increased risks to patients. The FDA and other regulatory bodies have stringent expectations for data integrity, requiring firms to implement robust strategies to manage data integrity risks effectively.
This webinar provides a comprehensive understanding of data integrity principles, and preventing data integrity issues. Participants will learn about regulatory expectations, the key principles of ALCOA+, and review FDA warning letters. This webinar will help attendees develop a compliant data integrity program that safeguards their organization’s quality and compliance efforts.
This workshop is designed for Quality Assurance professionals, Regulatory Affairs specialists, compliance officers, and anyone involved in data management within the pharmaceutical, food, or cannabis industries. It is particularly beneficial for those responsible for ensuring data integrity, managing data systems, and addressing regulatory requirements related to data integrity.
This workshop covers the following topics:
Develop a deep understanding of data integrity principles, their importance, and regulatory expectations.
Evaluating Compliance and Identifying FailuresLearn to evaluate data integrity compliance effectively and identify potential failures within your systems.
Designing Robust Data Integrity SystemsGain practical knowledge on how to design systems that incorporate data integrity by design, preventing issues before they arise.
All participants will receive a certificate of attendance upon completion of the workshop.
Note: Registration closes one week prior to the start of workshop.
Pharma, Cannabis
Kevin has over 25 years of pharmaceutical industry experience working for Novopharm Ltd. and Teva Canada Ltd. For 19 years, he was a supervisor in the following areas: Analytical Research and Development Stability, Quality Control Finished Product, Quality Control Stability, Quality Control Method Transfer, and Operational Excellence. Kevin is known as a positive person with an ability to motivate and guide people to reach their potential. He has demonstrated expertise in compliance, data integrity, laboratory investigations, root cause problem solving, recommending and implementing corrective and preventative actions (CAPAs), and continuous improvement of documentation and efficiency. Kevin graduated from the University of Western Ontario with a M.Sc. in chemistry and has a yellow belt in Operational Excellence. In his spare time, Kevin enjoys long distance running.
