Best Practices Components of an Effective QSR/GMP Training Program

Dave Peterson, Director, GMP & Quality Systems

Objectives for this session:

To identify and share industry best practices for employee training‘Share’ means group participation as well

Why look at ‘Best Practices?’

Because regulators often look at industry best practices to set the bar of expectation.

Often the case with many processes

There shall be written procedures describing…

Establish a process hierarchyHigh level Corporate SOP – Policies and Principles

Company training policies for all sitesEnsures consistency, QSIT Inspections start here

Site level SOPs (Flowcharts)Applications may vary

Training level SOPTraining processes, methods, Needs Analysis

A brief look at Needs Analysis

• Flow

• Is training part of the solution?• Why-why-why analysis• Case study – batch record errors (DHR)• Keep your ear to the ground

Requirements…Problems…Performance…Opportunity

Roles and Responsibilities Who’s minding the store?

• Senior management- Set policies, provide adequate resources – incl. staffing

• Line management- Assure employees are qualified- Those not fully qualified are supervised (mentored)

• Trainers- Provide methods/techniques, facilitate

• Employee obligation to acquire SKAs

Curriculum-driven approach

Each GMP/QSR position (role) has a training planQualification Curriculum – list of training itemsLearning sequence is importantMore to come later today

OJT Methodology – TTT – Train the Trainer

For job specific tasks – written instructions1) I show you how and you observe me2) You show me back and I’ll observe and give you feedback3) You show me working independently4) Evaluate w/ success criteria

Useful for SMEs as a process

Competency Evaluation

Absolutely expectedHow else do you know if successful?Many ways to measure -

- Test knowledge, demo skills, games, - simulations, etc.

SOP Training

Among most widely used, but least successfulMost SOPs are simply text, read and understandGet creativeBring to some kind of applicationEstablish multiple levels of ‘need’Approved, train, then EffectiveExamples? Best approaches?

Refresher vs. Ongoing

RefresherPeriodically repeat earlier training items (GMPs) where helpful Change up the venues, make it fun, ex. Jeopardy games, challenges,

humorous videos ,,,‘Re-qualify’ at defined intervals

Continuous, ongoing learningCompliance trends, awarenessNew regs, new applications, procedure changes, new systems…

Change Control

Training materials should be version controlled, 1.0 vs 1.01 Documents, CBTs, ppts., classroom outlines/contentTraining items in your LMS, esp. SOPsCurriculaCan establish what the item was

historicallyCan have legal implications

Contractors, temporary staff

ID a specific limited curriculum for each roleInclude:

Basic GMPs,Company policiesProcedures, OJT, and evaluation

Documentation, Reporting outcomes

Paper-based system is minimally acceptableElectronic databases (LMS) preferredManage and MonitorReport progress to Mgmt.Summarize results in standard reportsRecords retention

Onboarding new employees

Typically, classroom face to face discussionPre-requisite: complete CBTs as prepCover Co. policies and HR practicesReinforce corporate culture, ethics, conductMeet senior managers Move on to department training plans, OJT

Quality Oversight QTraining system should have Quality review and approvalTraining departments can be decentralizedQuality = Ownership of the entire GMP training process, not HRQuality’s role is to view success at 50k levelCan provide valuable insight in to the training needs in manufacturing and development

Is operator qualified on this equipment?

MES

Complete Training Matrix (role and resource based curricula)

LMS determines if the operator is qualified.

ComplianceWire

Grant Access

Yes

No

Operator prompted to train LMS provides applicable training Just in Time

Biometric Operator Login

Operator completes training

Yes

No

Supervisor is notified

Prevent Access

EDMS

Instructor LedReal time biometric attendance capture stand-up training

Real time on current SOPs

ComplianceWire & Manufacturing Control – Case study