This webinar delves into the history, rationale, purpose, and GMP requirements applicable to the manufacturing, packaging, labeling, testing, and control of pharmaceutical products. Participants will gain practical knowledge of the essential elements and quality systems necessary for GMP compliance in the pharmaceutical industry. Additionally, the webinar will explore the consequences of non-compliance, equipping attendees with the insights needed to maintain high standards and ensure product integrity. Join us to enhance your understanding of GMP principles and their application in maintaining compliance and quality in pharmaceutical operations.
This workshop is designed for Directors, Managers, Supervisors, and Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices, and allied industries. It is particularly valuable for professionals involved in Regulatory Affairs, Clinical Research, Quality Assurance, Documentation and Technical Writing, Product Submission, Project Management, Training, and Product Development. Additionally, consultants and other stakeholders who collaborate to launch products will benefit from this comprehensive overview of GMP requirements and compliance.
This workshop covers the following topics:
Understand the foundational principles of Good Manufacturing Practices (GMP) and their significance in ensuring product quality and regulatory compliance in pharmaceutical manufacturing.
Proficiency in Documentation and Record Keeping:Develop the skills needed to create comprehensive GMP documentation, including standard operating procedures (SOPs), training materials, and validation protocols, and maintain accurate records in compliance with regulatory requirements.
Effective Quality Control and Assurance:Gain expertise in implementing quality control and assurance measures, including methods development, specification setting, sanitation programs, and deviation investigations, to ensure product quality and safety throughout the manufacturing process.
Preparedness for Regulatory Inspections:Learn best practices for hosting inspectors and auditors, including strategies for effective change control, validation, and addressing industry trends, to ensure readiness for regulatory inspections and maintain GMP 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.
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.
