Best Practices Components of an Effective QSR/GMP Training Program. Dave Peterson, Director, GMP & Quality Systems

Transcription

1 Best Practices Components of an Effective QSR/GMP Training Program Dave Peterson, Director, GMP & Quality Systems

2 Objectives for this session: To identify and share industry best practices for employee training Share means group participation as well

3 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

4 There shall be written procedures describing Establish a process hierarchy High level Corporate SOP Policies and Principles Company training policies for all sites Ensures consistency, QSIT Inspections start here Site level SOPs (Flowcharts) Applications may vary Training level SOP Training processes, methods, Needs Analysis

5 A brief look at Needs Analysis Flow Requirements Problems Performance Opportunity Is training part of the solution? Why-why-why analysis Case study batch record errors (DHR) Keep your ear to the ground

6 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

7 Curriculum-driven approach Each GMP/QSR position (role) has a training plan Qualification Curriculum list of training items Learning sequence is important More to come later today

8 OJT Methodology TTT Train the Trainer For job specific tasks written instructions 1) I show you how and you observe me 2) You show me back and I ll observe and give you feedback 3) You show me working independently 4) Evaluate w/ success criteria Useful for SMEs as a process

9 Competency Evaluation Absolutely expected How else do you know if successful? Many ways to measure - - Test knowledge, demo skills, games, - simulations, etc.

10 SOP Training Among most widely used, but least successful Most SOPs are simply text, read and understand Get creative Bring to some kind of application Establish multiple levels of need Approved, train, then Effective Examples? Best approaches?

11 Refresher vs. Ongoing Refresher Periodically 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 learning Compliance trends, awareness New regs, new applications, procedure changes, new systems

12 Change Control Training materials should be version controlled, 1.0 vs 1.01 Documents, CBTs, ppts., classroom outlines/content Training items in your LMS, esp. SOPs Curricula Can establish what the item was historically Can have legal implications

13 Contractors, temporary staff ID a specific limited curriculum for each role Include: Basic GMPs, Company policies Procedures, OJT, and evaluation

14 Documentation, Reporting outcomes Paper-based system is minimally acceptable Electronic databases (LMS) preferred Manage and Monitor Report progress to Mgmt. Summarize results in standard reports Records retention

15 Onboarding new employees Typically, classroom face to face discussion Pre-requisite: complete CBTs as prep Cover Co. policies and HR practices Reinforce corporate culture, ethics, conduct Meet senior managers Move on to department training plans, OJT

16 Quality Oversight Q Training system should have Quality review and approval Training departments can be decentralized Quality = Ownership of the entire GMP training process, not HR Quality s role is to view success at 50k level Can provide valuable insight in to the training needs in manufacturing and development

17 ComplianceWire & Manufacturing Control Case study Biometric Operator Login MES ComplianceWire EDMS Is operator qualified on this equipment? Complete Training Matrix (role and resource based curricula) Real time on current SOPs Instructor Led Yes No LMS determines if the operator is qualified. Real time biometric attendance capture stand-up training Operator prompted to train Yes LMS provides applicable training Just in Time Supervisor is notified Grant Access Prevent Access No Operator completes training