Standard Operating Procedures (SOPs) are vital for ensuring consistency, quality, and compliance in regulated industries. Regulatory agencies require documented procedures for all systems and operations impacting the safety and quality of pharmaceutical products. SOPs are among the most frequently audited documents during GMP inspections to verify they reflect current practices, follow regulatory standards, and are adhered to as written.
This masterclass provides essential training for developing SOPs that are clear, practical, and effective. Participants will learn the fundamentals of SOP writing, from structure and formatting to roles and responsibilities, change control, and maintenance. By the end of the session, attendees will have the knowledge to create SOPs that promote operational efficiency, regulatory compliance, and audit readiness.
This workshop is ideal for individuals involved in the organization, writing, or management of SOPs required for GMP, GPP, GVP, or GCP purposes. It is particularly beneficial for quality assurance professionals, regulatory affairs specialists, technical writers, and team leads responsible for ensuring compliance and quality in their organizations.
This workshop covers the following topics:
Understand the Role of SOPs in Compliance
Gain a clear understanding of the importance of SOPs for regulatory compliance and operational consistency.
Master the Structure and Writing of SOPsLearn how to structure and write SOPs effectively, ensuring they are clear, concise, and user-friendly.
Develop Skills in Change Control and MaintenanceUnderstand how to manage SOP updates through change control and maintain them to reflect current practices.
Apply Practical Techniques for Effective SOP ManagementParticipate in interactive exercises to reinforce best practices in SOP writing and management.
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
Jason Chu is an experienced laboratory instructor at AAPS focusing on quality control and research and development functions in the pharmaceutical industry. He is an expert in HPLC, Dissolution, Pharmaceutical Laboratory Tests and GMP regulations. Beyond the classrooms at AAPS, he has led corporate training covering topics on WHMIS, health and safety, GMP regulations and data integrity.
Prior to joining AAPS, he was an Analytical Research and Development Chemist at Apotex Inc. – task with laboratory investigations, method validation, API screening and process validation support. During his time in R&D, he was appointed as a Designated Compliance Coordinator (DCC) to conduct regularly scheduled self-audits for continuous compliance improvement. At Apotex, he also held position as a Quality Control Chemist – testing raw materials, in-process products, finished products using a variety of laboratory techniques and instruments. In that role, he was also designated as a Subject Matter Expert (SME) task with responding to audit requests conducted by Health Canada and FDA.
