Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success
Standard operating procedures (SOPs) are a fact of life in regulated industry. They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections. In fact, most FDA enforcement actions center around – or at least mention – SOPs. Often times, SOPs can actually work against you as they are too complicated, difficult to follow, or simply poorly worded. This can snowball into more issues as SOPs are changed and made more confusing. In the end, your product quality suffers and sanctions pile up.
However, by applying some simple best practices – to the structure, content, and the SOP process itself – you can begin to free yourself from “nightmare SOPs.”
During our interactive, 90-minute online course, you will learn:
- What the regulatory requirements for SOPs are – and what procedures are required by the regulations
- How to make SOPs easy to follow and use – best practices for SOP structure
- How to ensure your SOPs do what you want them to do – recommendations for SOP content authoring
- What you need to consider in your process to ensure you get the results you want – best/common industry practices
This course will be of benefit to anyone who authors standard operating procedures, whose process must be defined in procedures, or who manages an SOP system. Information provided will be useful to individuals at various levels including director, manager, supervisory, and lead/senior personnel with SOP system responsibilities. This includes all GMP operational functions and personnel, including manufacturing, QA, QC, engineering and facilities, supply chain, training, and more. Additionally, R&D functions that draft and control SOPs as part of product and process development – and transfer to production –will also benefit.
Joanna Gallant is an experienced, solutions-driven quality professional with over 20 years of technical and operational experience within pharmaceutical, biotechnology and medical device manufacturing environments. Over her career she has provided regulatory, technical, skill and management development training support to all operations functions as well as IT, R&D, customer service and senior management.
Over her career, she has held positions in quality assurance, laboratory and training roles, which enables her to translate operational experience into training. She has established and led multifunctional and global project teams, and worked both as an individual contributor and a manager, and can speak from various perspectives as a result. She is well versed in instructional systems design, problem solving and root cause analysis skills, and she uses these skills to identify problems and solutions for performance and process improvement, and to analyze training systems for gaps and training programs for effectiveness.
Joanna regularly speaks at industry meetings and conferences on topics including root cause analysis, design and development of competency-based training, and interactive training design. She has been in leadership positions in the Massachusetts-based BETA organization for the last 10 years, and was asked to join the GMP TEA, Inc. Board of Directors in 2008. She is one of the founders of and an instructor in the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011.