Human Error Prevention (HEP) - Risk Factors and Strategies
Course Director
Course Fee
$2150.00 Regular Registration
$1950.00 Early Bird Pricing (Register 30 Days in Advance)
Course Brochure
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Future Live Stream Sessions (click to register)
Course Description
Edwards Deming, the famous pioneering leader of Toyota in the mid-1900’s, widely regarded as the Father of Modern Quality, said: “85% of the reasons for failure are deficiencies in the systems and process rather than the employee.” Many studies place that number at 95%. This course challenges traditional thinking on what causes, and how to prevent, errors and deviations, and helps transform organizations from looking for people’s errors, to finding system flaws and harnessing people for solutions. HEP is a well-researched, well documented field adopted by many industries (e.g. aerospace, nuclear) decades ago. This highly interactive course provides practical tools and strategies for preventing deviations, rather than writing and closing them faster. It focuses on practical application without the need for costly equipment/facility changes, software, validation, or even change control in most cases.
The course includes an overview of key definitions, importance, human error causes, and myths vs. facts across industries to provide strong foundational knowledge and background. It then focuses on the many risk factors present in the biopharm/device industry, and goes through the top causes of, and strategies for preventing, human errors in this fast-paced, error prone environment. The course then focuses on specific application and practical HEP tools and implementation best practices to help attendees apply the learning at their firms.
This interactive course includes audience questions and polling, activities and exercises to help participants apply and retain the knowledge.
Who Should Attend
This comprehensive 15-hour course will be valuable to all personnel working in a GMP manufacturing environment, including Manufacturing, Quality Control, Quality Assurance, Quality Systems, Supply Chain, and Facilities and Engineering employees. It will benefit individual contributors, supervisors, area managers, and leadership decision makers, especially those involved in front line operations, deviation management, investigators, continuous improvement, and operational excellence.
Certification Tracks
- (BDCP) Biopharmaceutical Development Certified Professional™
- (CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional™
- (CPVP) Certified Process Validation Professional™
- (GLPCP) Good Laboratory Practices (GLP) Certified Compliance Professional™
- (GMPCP) Current Good Manufacturing Practices (cGMP) Certified Professional™
- (GRACP) Global Regulatory Affairs Compliance Professional™
- (PDCP) Pharmaceutical Development Certified Professional™
- (QSRCP) Quality System Regulation (QSR) Certified Compliance Professional™
Related Courses
- Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
- Change Control - GMP Requirements and FDA Enforcement
- Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies
- Good Manufacturing Practices Training | GMP Course
- Laboratory Equipment Validation and Qualification
- Pharmaceutical Root Cause Analysis of Failures & Deviations – Developing an Effective CAPA Strategy
- The Drug Development Process From Concept to Market
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.