human factors fda guidance 2017 - Reducing Human Error through Procedures -By Compliance Global Inc

OVERVIEW
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally 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 really important to understand human behavior and the psychology of error as well as understand exactly where the instructions weaknesses are, so procedures can be human engineered, improved and/or fixed.
WHY SHOULD YOU ATTEND
Procedures are very important for both execution and audits. These should be written for users without missing important information for regulators. Usually procedures have weaknesses that harm productivity, quality and regulatory standing.
AREAS COVERED
• SOP writing outline
• Content development
• The rational for procedure use
• Regulatory compliance background
• 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
LEARNING OBJECTIVES
• Use of electronic information networks for procedure access
• Procedure styles
• Universal purpose of procedures
• 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”
WHO WILL BENEFIT
• QA/QC directors and managers
• Process improvement/excellence professionals
• Training directors and managers
• Plant engineering
• Compliance officers
• Regulatory professionals
• Executive management
• Manufacturing operations directors
• Human factors professionals
For more Details Please visit: http://bit.ly/2ePuHcm
Email: support-AT-complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510
SPEAKER
Ginette Collazo, PH.D is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas.
She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others.
Also has implemented human error reduction programs and technology in many more small and mid-sized drug and device companies.
An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.