This workshop covers the fundamentals of Annual Product Quality Reviews (APQRs), focusing on regulatory compliance, process improvement, and preparing for GMP inspections. Participants will learn the core principles, the contents of an APQR, and how to assess APQR data for corrective actions and improvements.
This workshop is ideal for individuals involved in the preparation, review, or management of Annual Product Quality Reviews required for GMP compliance. It is particularly beneficial for quality assurance professionals, regulatory affairs specialists, manufacturing personnel, and team leads responsible for ensuring product quality, regulatory compliance, and continuous improvement in their organizations.
This workshop covers the following topics:
Gain a clear understanding of how APQRs ensure regulatory compliance and support quality management.
Master the Structure and Content of APQRsLearn how to structure and organize APQR data effectively, ensuring it is comprehensive and aligned with regulatory expectations.
Develop Skills in Data Analysis for APQRsUnderstand how to analyze and interpret statistical data from APQRs to identify trends, deviations, and areas for improvement.
Apply Practical Techniques for APQR PreparationParticipate in hands-on exercises to reinforce best practices in preparing and reviewing APQRs, with a focus on corrective actions and compliance.
All participants will receive a certificate of attendance upon completion of the workshop.Note: Registration closes one week prior to the start of workshop.
AAPS
Instructor
A Chartered Chemist, her career spans 30 years in the pharmaceutical industry. She started as a stability chemist at Sterling Drug and soon moved to Health Canada where she worked over 13 years in various capacities with the Health Product Branch Inspectorate (HPBI) in the Ontario region. Her expertise include Medical Devices Inspection, Drug GMP Inspection and Compliance issues. She is currently the director of QA/QC at Experchem Laboratories Inc. where she is responsible for overseeing and maintaining the GMP compliance of the chemistry and microbiology laboratory, Auditing, and providing Quality Control Services to importers and distributors.
She has a degree in chemistry from York University and a diploma in Pharmaceutical Chemical Technology from Seneca College.
