This workshop provides comprehensive training on the critical aspects of High-Performance Liquid Chromatography (HPLC) documentation and data integrity within regulated environments. Participants will gain an in-depth understanding of the documentation requirements for mobile phase, standard, and sample preparation. The session will cover key topics such as HPLC system documentation, system suitability, GMP injection sequences, and the necessary injection data requirements.
Attendees will learn how to ensure peaks are properly integrated, review chromatograms, and verify that injections are processed to generate reliable results. The workshop will also focus on re-processing injections, identifying possible data integrity issues, and implementing controls to ensure compliance with regulatory standards. Through case studies and real-world examples, including FDA Form 483s and Warning Letters, participants will understand common pitfalls and how to identify potential issues and risks associated with their HPLC data. This workshop is designed to equip professionals with the skills and knowledge needed to ensure the integrity of chromatographic data and prepare for regulatory inspections.
This workshop is ideal for professionals who audit, or oversee the quality of, HPLC data in a regulatory environment. It is particularly beneficial for quality assurance (QA) specialists, laboratory managers, and compliance officers in pharmaceutical, food, or cosmetic settings. Attendees will gain practical knowledge of GMP documentation, system suitability, injection sequences, data integrity controls, and regulatory compliance, ensuring the accuracy and reliability of HPLC results. This session is also valuable for individuals preparing for Health Canada or FDA inspections and understanding common data integrity issues.
This workshop covers the following topics:
Understand the application of Good Manufacturing Practices (GMP) to HPLC data and learn to identify potential data integrity issues. Develop the skills to audit HPLC documentation, ensuring compliance with regulatory standards.
Understand HPLC Injection Sequences and Compliance Risks:Learn the essentials of GMP injection sequences and how to recognize compliance risks. Acquire the knowledge to effectively implement data integrity controls to safeguard HPLC data quality and reliability.
Preparedness for Regulatory Inspections:Ensure your HPLC data is “GMP inspection ready” by understanding the critical elements regulators focus on during inspections. Learn how to prepare data and documentation for successful audits.
Understand What Regulators Are Looking for During Inspections:Gain expertise by analyzing case studies and real-world examples, including FDA Form 483s and Warning Letters, to better understand HPLC audit observations and prepare for regulatory inspections.
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.
