Learning Leader Responsibilities

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• Trainers
• Inform when learners need CBT training
• Provide time for:
• Preparing to train
• Training
• Updating CBT materials
• Ensure that during training they are able to focus on the learner.
• Do not assign them to run a process and train at the same time.

• Assessors
• Inform when learners need to assess
• Provide time for:
• Preparing to Assess
• Administering Performance Assessments
• Updating CBT materials

• Identify subject matter experts to gain CBT Trainer and/or Assessor qualification.
• Best practice is to have qualified Trainers and Assessors on each shift.

Supporting your Competency Team

• Review your departments training procedure to see what CBTs are assigned automatically by position and which need to be manually assigned when applicable for a learner.
• Aseptic SOP-01068
• Analytical Development and MS&T WI-01893
• Microbiology WI-01347
• Production Operations SOP-01244
• QC Chemistry WI-01489

• Notify your department learning administrator when CBT training needs to be assigned.

• Monitor CBT training completions using:
• My Team page in Veeva (SOP-00966)
• ELMS Training Dashboard in Veeva (SOP-00966)
• Skills Matrixes (in MS teams where applicable)

• Do not assign learners to perform a GxP task independently until they are fully qualified.
• During training the learner must be overseen by a Trainer, Lead, Supervisor, or other qualified individual.

Monitoring Qualification Status

• Direct Trainers and Assessors to update CBT materials as needed.

• Evaluate changes to procedures, policies, or work flow and determine when additional training is required.

• Identify when changes are needed to core CBTs for a position.
• Notify your department training specialst or designee if this is the case.

• Evaluate updates to CBTs to determine when requalification is required.
• Notify your learning administrator or training specialist if you need individual learners to requalify on a CBT.
• Notify list-L&D@tolmar.com if you need all learners to requalify on a CBT.

Provide Feedback for Continuous Improvement

• Meet with the Trainer and Assessor to understand where the learner failed.

• Determine appropriate next steps which could include:
• Giving the learner more time to train before attempting again.
• During training the learner must be overseen by a Trainer, Lead, Supervisor, or other qualified individual.
• Obtaining reasonable accomodations for the learner, such as prescription safety goggles or screen reading technology.
• Deeming the learner Not Qualified and not assigning them to complete the GxP task in the future.

Determine the Path Forward for Learners who Fail CBT Assessments Twice