Definition of a Robust Training System:
6 Elements of a Robust Training Systems
GXP Training & Curricula Management
The first essential element is an approved set of training requirements for each directly involved position. This includes GXP Basics for New Hires.
Structured OJT for Procedures
The next essential element is to gain consensus & commitment for the methodology used to teach task related and equipment based SOPs aka OJT Steps.
Use of Qualifed Trainers
A key element of an RTS, is the deployment of qualified and trained SMEs as Department Trainers. Being the most senior or most knowledge technician does not automatically qualify someone as an effective OJT Trainer. Regulatory expectations now include a more rigorous process for qualifying SMEs.
Employee Qualification & Training Effectiveness Measures
Completion of training curricula requiremetns is no longer a sufficient form of evidence. OJT Methodology needs to include the process for qualifying employees as a measue of demonstrated confidence in employees abilities to perform procedures accurately and completely without the supervision of his/her trainer.
GXP Refresher Series
The old standard for companies in the Life Sciences was once a year. Today, the expectation is at least twice a year with some companies offering more choices and points based programs towards GXP Training Requirements.
Training Documentation Process
Alas, this is where requirements, documentation, tracking and reporting come togethr ans is the last essential element of a RTS. Whether paper based or digital, all of the other elements must be integrated into a logical process that enables employeee to be trained and qualified to perform the functions of their job duties.
HPIS Consulting Offerings
Robust Training Systems, HPIS Performance Gaps, Customized Training Design and Delivery, SME Inspection Readiness and
Back Room Roles Training
Our Services
Robust Training Systems and Qualifying SMEs
Most popular request is to fix a broken training system.
Qualifying SMEs across 3 programs:
*Qualified Trainer Workshop
*Technical SME as Classroom Trainer
*SMEs as Investigators
Annual GMP Refreshers
Clients have three options to meet their site learning needs:
*Complete Outsource
*Outsource Design / Client Delivers
*HPISC conducts a Rapid Design Workshop with Internal Trainer
HPISC offers complementary brainsparking chats to inspire your next GMP Refresher design.
Improving Human Performance Gaps
Begins with a complementary discussion to determine whether Performance Cause Analysis is needed.
Performance Cause Analysis provides data for the diagnosis.
Inspection Readiness
Inspection Readiness Training Curriculum
Training and Live Coaching Front Room . Back Room Roles
Coordination of SME
IInterviewing Practice Sessions
Ready to start a conversation with Vivian? Send email to vbringslimark@hpisconsulting.com.
What is HPI?
Human Performance Improvement (HPI) can be viewed as the study of human behavior in the workplace and the myriad factors that shape employee performance.
Improving employee (human) performance becomes a priority when errors and deviations cause the organization to miss goals or performance targets and when corrective actions become strategic projects.
WHAT MAKES VIVIAN DIFFERENT?
FIND OUT WHAT MAKES VIVIAN UNIQUELY SUITED FOR HPISC
VBringslimark_Difference_2019.pdf
Adobe Acrobat document [119.7 KB]
FIND OUT WHAT MAKES VIVIAN UNIQUELY SUITED FOR HPISC
VBringslimark_Difference_2019.pdf
Adobe Acrobat document [119.7 KB]
Contact Us Today!
HPIS Consulting, Inc.
Lake Worth, FL 33467
Phone: +1 203 4708363 +1 203 4708363
E-mail: vbringslimark@hpisconsulting.com
HPISC Updates:
PDA TRI Courses:
June 17, 2020 | Investigating Human Error to Correct Operator Error | Missed it? Contact Vivian to learn more about the Blended Training Curriculum.
December 10, 2020 | Training Effectiveness - What's Your Design Strategy | PDA HQ - Bethesda, MD
Newest eBook is more like a self eGuide for GMP Refresher makeovers.
"10 Commandments" Linked In Article: From Thou Shall ... Everyday Workplace Behaviors
Newest Theory vs. Practice Blog
Sampling of HPISC Client Requested GMP Training Courses
Annual Refreshers:
Good Documentation Practices: Where DID all the rules come from anyway?
7 GMP Work Habits I, II
Operator Error: I,II, III
Intermediate Courses:
System Based Inspections
State of Control: Are we ensuring SQuIP?
Core GMP Assessment Team Workshop
Quality System Core Audit Team Workshop
GMP Basics Series
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