In the Pharmaceutical industry, auditing contractors, vendors, and suppliers isn’t just a regulatory requirement—it’s a vital quality practice. Ensuring GMP compliance and robust Quality systems within these partnerships is crucial, yet often overlooked. Effective auditing is essential, guaranteeing that external entities meet the required quality standards, resulting in regulatory compliance and enhanced product quality. The role of an auditor in the pharmaceutical industry demands a diverse skill set—from the fundamentals of auditing to intricate technical knowledge across various areas such as classical chemical APIs, biological APIs, and different dosage forms. This workshop addresses these diverse needs by providing insights into technical areas and highlighting critical process steps essential for a comprehensive audit. Designed for both internal and external auditors, this course equips participants with the necessary skills to navigate the complexities of auditing in the pharmaceutical sector, covering aspects such as audit preparation, design, Data Integrity, and more. Join us for a structured approach to audit readiness, ensuring companies are consistently prepared and confident in their compliance efforts. Let’s embark on a journey towards controlled, stress-free audit readiness, ensuring companies are confident 100 percent of the time.
This workshop is tailored for individuals regularly tasked with conducting audits on suppliers and/or internally, including quality assurance professionals and both internal and external auditors. It caters to anyone requiring an understanding of industry standards for auditing within the pharmaceutical and allied industries, especially those engaged in external supplier audits. Additionally, it is beneficial for Qualified Persons (QP) seeking to enhance their auditing proficiency.
This workshop covers the following topics:
Audit Fundamentals
Learn the roles and responsibilities of auditors, various audit types, scheduling considerations, and the distinctions between internal and external audits.
Audit Planning and PreparationDevelop a deep understanding of the industry standards/regulations for audits, as well as audit administration, authority, scope, purpose, type, scheduling, checklist construction, and resource management.
Audit PerformanceDiscover the importance of conducting audit meetings, interviews, and data analysis. Learn how to document findings, enhance writing skills, and provide constructive feedback.
Audit Consolidation and ReportsGain insight into the process of consolidating audit findings and preparing comprehensive reports. Additionally, learn about corrective actions, fostering continuous improvement, and ensuring departmental and management accountability.
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.
