Writing Effective Standard Operating Procedures and Work Instructions

Presented by Charles H. Paul

Writing effective Standard Operating Procedures and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute. Knowing the most effective and efficient processes for gathering, organizing, and writing technical documentation is absolutely critical to providing significant value to a dreaded, avoided, and seemingly unimportant work task.

This webinar will discuss how to transform your regulatory documentation process into a profit center, an operational force multiplier in how you run your business, and an effective central focus of your technical training function.

Writing Followable Procedures: Avoid Procedure Related Deviations

Presented by Ginetter Collazo

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is essential to understand human behavior and the psychology of error as well as understand exactly where the instruction's weaknesses are so that procedures can be human engineered, improved, and fixed.

Best Practices For How To Structure And Write A Standard Operating Procedure (SOP)

Presented by John J. Meola

Learning the key elements and steps, the vocabulary and definitions applicable to the SOP creation process will be covered in our Webinar. The process can be a little confusing to the uninitiated. We will review the main elements of SOP formation and describe how to compose the document in sufficient detail to reflect your technical and managerial acumen.

When done correctly, writing an SOP is not a one-person exercise, no matter how good that person is. It typically involves several levels of talent in an organization. This Webinar covers a lot of ground and you will learn valuable information on the methodology and concepts behind why this document is the gold-standard in running a business efficiently over the long term.

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance problems.

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry. Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development, and the effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.

Ginette Collazo, Ph. D. is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDA news Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, Pharmaceutical Industry Association, and International GMP Conference.

John J. Meola, is a Certified Safety Professional (CSP) and an Associate in Risk Management Degree (ARM). He has over 25 years of experience in construction, insurance, manufacturing, and risk management. He is an Adjunct Instructor at the Virginia Commonwealth University School of Business and has a BA in Education. He is the Safety Director for Pillar Inc. based in Richmond VA and is a consultant with private clients in various industries. He is an OSHA Construction Safety Outreach Trainer and is the author of two safety handbooks. He is also a regular contributor to several construction trade publications and presents seminars to select audiences all over the United States.