Course overview
Standard Operating Procedures (SOPs) are central to compliance in regulated industries. When written well, they provide clarity, consistency and confidence. When written poorly, they create confusion, inspection findings and operational risk.
This interactive course provides a structured, best practice approach to writing, reviewing and managing SOPs in pharmaceutical and biotech organisations. It combines regulatory insight, practical writing techniques and process mapping tools.
The course also explores how artificial intelligence is beginning to reshape SOP creation and lifecycle management, while maintaining regulatory control.
CPD Hours: 6
Course Content
- Day 1
- Foundations of effective SOP writing
- Writing and structuring SOP content
- Implementation, review and compliance
- The Future of SOPs: AI in creation and management
Speakers
Laura Brown
Dr Laura Brown is an independent pharmaceutical QA consultant and is a recognised expert in QA including auditing SOPs for regulatory compliance. She has more than 25 years’ international experience in the pharmaceutical industry in a number of senior roles and has worked for companies including GSK, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in several quality assurance roles which have included writing, reviewing and auditing SOPs and CAPA implementation and has helped companies prepare SOPs and review CAPA systems to meet regulatory requirements.
