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.
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.
