This document provides information about a two-day training workshop on human error investigations in the pharmaceutical and medical device industries. The training will take place on September 28th and 29th in Dublin, Ireland. Day one will cover topics such as what is human error, influencing human factors, and reducing human error. Day two will focus on elements of an effective investigation including root cause analysis tools and assigning categories of human error. Early bird registration is €800 by August 28th, and standard registration is €890, which includes training materials, lunch, and refreshments. The workshop is aimed at project managers, quality assurance personnel, manufacturing staff, and others.

1. Validation & Compliance LTD.
PATRICK ROURKE
Please contact: Dr. Fiona Gilchrist
Email: fgilchrist@pharmabioserv.com
Office: +353 21 4619034
Mobile: +353 834434913
MAGALY AHAM
HUMAN ERROR
INVESTIGATIONS
TRAINERS
BOOKING/REGISTRATION DETAILS
Early Bird: €800 if registration is confirmed by August 28th
, 2016.
Groups: €800 for second and subsequent attendees.
Group discount: Please request special prices for two or more
people wishing to attend from the same company.
Cost includes: Training Pack, Refreshments and Lunch
*VAT is not included.
CosT: €890 for 2 days of training including
Course materials, lunch & refreshments
TRAINING OUTLINE
W O R K S H O P
N I B R T , D U B L I N , I R E L A N D
&
SEPT. 28TH
- 29TH
DAY 1 - Human Error in the Pharmacuetical & Medical Industries
DATE: Wednesday, September 28th
, 2016 / Duration: 8 hours
• Introduction
• What is Human Error?
• Influencing Human Factors
• Why do humans make mistakes?
• Reducing Human Error
• Human Error - Current vision of regulatory agencies
• Human Error Metrics
• Human Error Workshop
• Decision Tree for Human Error Classification
DAY 2 - Human Error Reduction - Effective Investigations in the
Pharmacuetical & Medical Devices Industries
DATE: Thursday, September 29th
, 2016 / Duration: 6 hours
• What is an investigation?
• Regulatory requirements linked to human error investigations
• Regulatory citations linked to human error investigations
• Types of investigations
• Elements of an investigation:
- Problem Statement
- Scope
- Risk Assessment / Impact Analysis Tools
- Systematic methods for Root Cause Analysis (Cause
- and Effect Diagrams, FTA, 5 Why's, Is/Is not)
- Tools to assign and categorize human errors as the root
cause
- Effective CAPAs to human errors reduction
• Monitoring the Quality System State - Metrics related to
human error
tracking
• Investigations Review Workshop - Is Human Error the real
root cause?
Overview of data integrity - current expectations of eu inspectors and
fda regarding data integrity threats and issueS
DURATIONS: 2 HOURS
We are delighted to welcome Key
Health Product Regulatory Authority
(HPRA) staff to our Training and to
announce that Dr. Amy Kelly, Quality
Defects and Recall Manager from
HPRA will be presenting on a Key
Investigations Topic.
RESERVE
NOW
*
who should attend?
what your attendees will learn
• Project Managers/Leaders
• Q&A/QC
• Manufacturing Personnel
• Technical Services
• Planning/Procurement
• Validation
• Engineering
• Information Technology
• Management
• Why Humans make mistakes and how to
analyze, and identify Human Errors
• Error Prevention Techniques
•How to improve and optimize procedures,
workplace design, and more to imporve
human performance
• Why Human Error is a factor in deviations
but not a Root Cause
Holds a Bachelors Degree in Chemistry from the University of Puerto Rico and a Master
Degree in Bioscience and Regulatory Affairs from the Johns Hopkins University in
Maryland, US. She is the Vice President of Compliance and US Operations for Pharma-Bio
Serv, US Inc. With over 20 years’ hands-on experience in positions of increasing
responsibility in companies both in Puerto Rico and the United States. She holds an
outstanding career track record of improving compliance, quality, efficiency, efficacy and
maximization of manpower through continuous process improvement efforts.
A Lean Six Sigma Green Belt Certified Consultant. Patrick has over 10 years’ experience in
the Pharmaceutical Industry working in operations and continuous improvement roles
for leading multinationals such as Pfizer and Johnson and Johnson. He holds a
Biomedical Engineering Degree from Arizona State University and a Master´s degree in
Bioengineering from Boston University. His quest for operational excellence using Lean
Six Sigma tools has led him throughout his career to manage, train and develop large
teams to become proficient in process improvement techniques with special emphasis
on packaging operations.
www.pharmabioserv.com
www.pharmabioserv.com