3 hr Live Webinar Reduce Human Error on the Drug and Device Manufacturing Processes

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 3 Hrs Live Webinar

"Hear By Dr. Ginette Collazo — a 15 year veteran of helping drug, biologic and device firms reduce manufacturing errors"

Human Error as the Root Cause

Description

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

To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches to address human performance issues in GMP related environments by using a specific methodology to investigate, correct, prevent and avoid re-occurrence of these issues

Areas Covered

•    SOP writing outline
•    Content development
•    The rational for procedure use
•    Regulatory compliance background
•    Universal purpose of procedures
•    Background on Human Error Phenomena
•    Importance of Human Error Prevention/reduction
•    Training and human error
•    Facts about human error
•    Human Error as the Root Cause
•    What is Human Error?
•    How is Human Error controlled?
•    Common mistakes: Memory failures, Overconfidence, We believe we are above average, Visual Detection, Vigilance Effectiveness.
•    Types of error
•    Human error rates and measurement
•    Trending and Tracking

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

Industries who can attend

This 180-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Ginette M. Collazo

Dr. Collazo has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, 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.

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.

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.

 

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