About The Event
Why You Should Attend
Procedures are essential for both execution and audits. These should be written for users without missing relevant information for regulators. Usually, procedures have weaknesses that harm productivity, quality, and regulatory standing. We will discuss from content development to formats designed for human error reduction due to procedures.
Description of the Topic
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 instructions weaknesses are so that procedures can be human engineered, improved and fixed.
Areas Covered In the Seminar:
- SOP writing outline
- Content development
- The rationale for procedure use
- Regulatory compliance background
- Universal purpose of procedures
- The Human Perspective
- Human Error as a root cause
- The thinking and reading process
- Common mistakes and causes
- How to create and maintain a procedure
- Goals of a procedure
- Good Procedure Writing practices (Terminology, Formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions,”
- Procedure styles
- Use of electronic information networks for procedure access.
Who will benefit
- QA/QC directors and managers
- Process improvement/excellence professionals
- Training leaders and managers
- Plant engineering
- Compliance officers
- Regulatory professionals
- Executive management
- Manufacturing operations directors
- Human factors professionals
Free Handouts for Attendee
- Course material and slides
- SOP Template
Industries: Pharma & Food Safety, Pharmaceutical, Food Safety & Dietary Supplements
Dr. Ginette M. Collazo
Dr. Ginette M. Collazo obtained her PhD in Industrial/Organizational Psychology from the Interamerican University of Puerto Rico. Ginette has over 15 years of experience in the pharmaceutical industry with the Technical Training, Organizational Development and Human Reliability fields.
Her work experience is from Bristol Myers Squibb, Johnson & Johnson, Schering Plough and Wyeth, holds specialized studies in Human Reliability, and has authored various publications on this topic. Her most recent publication is "Error Humano: C4c06 Modelo de Determinación de Raiz Causa", a book that describes success factors that reduce human errors. Having implemented Human Reliability programs in various industries, she understands firsthand what works and what doesn’t when trying to change a culture from an error tolerant environment to an error free learning organization.
Currently she is the president of Ginette M. Collazo, Inc. a firm that works with organizations to improve productivity by helping them identify and implement innovative strategies that will warrant that business objectives and results are met and exceeded. GMC, Inc. specializes, also, in Human Error reduction allowing organizations to achieve savings and reduce/avoid unnecessary costs associated with people’s mistakes.
Ginette’s clients all over the world including Germany, Argentina, USA, Trinidad Tobago, Dominican Republic, Singapore, Europe, and more. She has been a guest speaker about these topics in several professional conferences including American Institute for Chemical Engineers Global conference, Center for Chemical and Process Safety, American Society for Quality, California State Lands Commission Prevention First 2010 conference, Interphex PR and NY, FDAnews, among others.
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