Implement an Effective CSV Personnel Training Program · 1 Implement an Effective CSV Personnel...

Implement an Effective CSV Personnel Training Program | Apr 2017 | 1

Ivonne del C. Ramos Senior Quality Engineering Manager,

Validation COE Leader

Implement an Effective CSV Personnel Training Program


• How many of you have a formal CSV Training program at your facility?

• How many of you have issues with CSV training program ?

• How many of you have audit observations due to inadequate CSV records?

• How many of you have plans to develop a new CSV training program at your facility?

Questions for the Audience


You are in the correct place…

We can help you to implement an Effective CSV Personnel Training Program


Course Objective & Approach

Objectives:

• Provide an overview of what is required to implement an effective CSV Personnel Training Program

Approach:

• Presentation

• Audience Interaction throughout presentation


Creation of a CSV education and certification

program

SECTION 1


CSV Education and Certification Program Purpose

• To ensure that authors and approvers of CSV records have the necessary knowledge to create and execute the CSV records according to established policies, procedures and regulations.

• To sustain CSV Program improvements and enhance the validation organization’s knowledge.


What type of CSV group do you have ?

Dedicated CSV Group

OR

Shared CSV Group

What are the….


Identify the target audience for each CSV Certification

How the target audience can be identified ?

o Need to identify possible authors and approvers for CSV records • CSV Engineers

• CSV Quality Engineers

• CSV Area Managers

• Or any other resource assigned to work on CSV !


Structure of CSV Validation Certifications

STEP 1 – Define what type of learning do you want ?

Conceptual and scenario-based eLearning

Initial training

Refresher training

How-to videos or eLearning

Instructor-led presentations

Instructor-led classroom exercises/workshops

Knowledge checks and quizzes

Certification tests

Work instructions and procedures

Quick reference guides

Peer-to-peer learning, on-the-job training, social media, learning communities


Structure of CSV Education Certifications

STEP 2 – Define certification levels

• CSV Fundamentals – Level 1

• CSV Fundamentals Proficiency – Level 2

• CSV Annual Refresher


Certification Level Recommended Content Training Type

CSV Fundamentals – Level 1 • CSV Validation Policy • CSV Validation Procedures • CSV Principles • CSV Workshop

R & A R & A IL IL + Hands on

CSV Fundamentals Proficiency - Level 2

• Comprehensive Test to challenge • Procedure Knowledge • Procedure Execution • Do’s and Don’ts

E-learning

CSV Annual Refresher • CSV Fundamentals- Level 1 (deployed after 1 year)

Combination of e-learning and a test depending on updated course content

Certification Content

Legend : • R&A – Read and Acknowledge • IL – Instructor Led • E-learning – e-module assigned in Learning Management System • Hands-on – Real exercise of creating a CSV Document


• Communication is important !

• Management needs to understand the goals / expectation of the CSV education and certification program to provide support and requested funding !

Communicate Goals/ Expectations


Certifications and Training Development/

Deployment

SECTION 2


You already decided the certifications to be created…


Creation of Training Materials

• Based on employees learning needs and not on what’s easy for your trainers.

• Directly related to your learning objectives • Consider Adult Learning Principles

• Come to training with a lifetime of existing knowledge, experience, and opinions

• Are goal-oriented • Want training that is relevant • Want training that is task-oriented • Learn when they see “what’s in it for them” • Want to be and feel respected

Elements to consider

• Learning Needs

• Opportunity for feedback

• Related to learning objectives • Break training materials into small chunks – easier to be understood

• Based on Audit Learning Principles (experienced, goal oriented, what’s in it for me, relevant)

• Order your chunks in a logical manner

• Inclusion of hands on examples • Consider the use of “blended learning” – training in different formats

• Allowance of trainees to have extensive participation (No monologue!)

• Regulatory or Audit Observations


PROs / CONs

Selection of deployment method for training process

Training deployment type

+ -

R & A • Individual pace • Easy to assign • Acceptable for general knowledge

Not enough for significant changes.

IL • Direct • Allows feedback • Highly recommended for specific

knowledge

Time consuming

E-learning • Individual pace • Effective when learning checks are

included.

Preparation, Cost and deployment at LMS.

IL + workshops • Direct • Immediate results are observed • Highly recommended to confirm

proficiency

Time consuming Preparation & Cost


• Intended Use

• User requirements

• Functional requirements

• Creating CSV Stand Alone records

• Testing – how to create testing according to intended use / requirements.

• Traceability Matrix

• Objective Evidence

• Good Documentation practices

• Software type requirements

Topics to consider for CSV ( not all inclusive)

Definition and Importance


• Can anyone be a trainer ?

Selection of Trainers


• A command of the material.

o A good trainer knows the material, lives it, breathes it, and can infuse their own experience into it.

• Preparation and practice.

o A good trainer makes delivering a class look easy and seamless.

• Rhythm and energy

o A great trainer is attuned to his or her own energy level and that of the class.

Trainers qualities


• Allow and encourage participants to learn from themselves

o There is a wealth of knowledge in the classroom, use it !

• Love for what they do

o Passion drives all !

Trainers qualities


• How I can develop excellent trainers ?

Train the Trainers Program


• Prepare participants to analyze their audiences and tailor materials

• Provides tactics for handling surprise situations and difficult participants.

• Provides best practices for engaging learners and encouraging discussion.

• Provide emphasis to the 5 steps learning method : o Discuss what they may already know.

o Describe the new content.

o Demonstrate how to perform key skills.

o Drill them by conducting a learning activity.

o Debrief what they learned.

Train the Trainers Program


What to do if people are not trained according to

the certification program requirements?

SECTION 3


• You are just starting with the education and certification process.

• Your people needs to continue creating and approving CVS records.

• What can you put in place to mitigate that your people is not still proficient in CSV ?

What would you do?


• What is an Independent Review process?

o It is a mitigation that allows to conduct validation activities while the authors and approved of CSV records are trained according to the validation certifications created.

o Is a review performed by a qualified independent resource to ensure that validation records are accurate, complete and compliant.

Establishment of an Independent Review process


• Creation of checklists

o Include all the criteria to be considered to ensure having stand alone, compliant and adequate documents.

o Checklist are used by an Independent Reviewer to document all the observations found during the review.

o The author should use the checklists to create the documents for avoidance of non compliant records.

How the Independent Review process is performed?


• Creation of checklists

o The author/approvers need to ensure that observations found are addressed prior to final approval.

o Data obtained from the checklist can be used for : • Targeting common issues and define action plans

• Create metrics to verify documents adequacy

• Reinforce some training areas

How the Independent Review process is performed?


Develop CSV training effectiveness

SECTION 4


Who needs a CSV training effectiveness process?

All of us !


Definition of CSV Training Effectiveness Strategy

• Training effectiveness strategy

o Sample CVS records • Create an effectiveness checklist

• Define evaluation criteria ( Critical, Major, Minor defects)

• Evaluate records against the effectiveness checklist

• Summarize results

– Check if issues are the same prior to the establishment of the CSV Education and Certification Program

» If so, something is wrong…


Example of an effectiveness checklist


• Now, you have some results about your CSV records…and they are not as expected.

Handling Training Effectiveness Failures


Handling Training Effectiveness Failures

• Define action plan

o 1:1 Interview with impacted personnel • Additional Training needed?

• Different Trainer needed?

• CSV Training materials inadequate?

• CSV Procedures inadequate?

o Perform re-training

o Repeat Proficiency Test

o Repeat the effectiveness strategy


• Create a metric for effectiveness process.

• Share results with Management.

• Evaluate CSV records adequacy through time to determine if improvements are observed.

Measuring effectiveness


Thanks !

Implement an Effective CSV Personnel Training Program · 1 Implement an Effective CSV Personnel...

Documents

Transcript of Implement an Effective CSV Personnel Training Program · 1 Implement an Effective CSV Personnel...