Training
Often the result of reductions in staffing, training organizations frequently lack the personnel and oversight required to ensure training effectiveness. Areas of focus include adequacy of staffing, training effectiveness, training materials (including course content, curricula), training methods, record keeping and reporting, and trending of deviations. Shop floor or lab bench observation or “polling surveys” prior to training are recommended to diagnose and to identify issues. Observation following training is recommended to ensure that training has been effective.
Experience includes assessments of training organization structure and function, training effectiveness, development of training materials, delivery, coaching, mentoring, train-the-trainer training, development and execution of “live” polling surveys.
Assessment of Training Department Structure and Function
Evaluation of training-related SOPs and actual practice; review of roles and responsibilities of manufacturing, quality, and training departments, training department organizational structure and staffing.
Experience includes preparation of gap assessment, recommendations and roadmap for organizational change to effect a sustainable solution.
Health Authority Inspection Preparation
Adequate preparation for Health Authority inspections can have a significant impact on inspection outcome. Preparation can include conduct of mock inspections (including preapproval inspections or PAI), targeted or general audits, preparation of talking points for known issues, and coaching on how to interact with health authorities. Response and commitments to health authorities in response to audit findings must be timely, well thought out, and completed per commitments to avoid severity of enforcement action.
Experience includes mock audits, preparation for Health Authority inspection, and a unique interactive training on how to interact with Health Authority auditors during an inspection.
Assessment of Training Effectiveness
Review of training material, delivery methods, assessment methods, frequency of training-related deviations, interviews, polling to determine if training has been effective.
Experience includes detailed review of training materials, observation, interviews with representatives at levels within organization as well as “live” polling surveys to identify training issues. Detailed recommendations for improvement were provided.
Lesson Plans
Review of and revision to lesson plans to ensure conformance to job function and procedures.
Experience includes revision to over 50 site-wide lesson plans to ensure that lesson plans made logical sense in terms of curricula and module, but were also aligned with current SOPs.
Training Content/Delivery
Prepare specific training materials, including lecture materials, handouts, knowledge assessments.
Experience includes preparation and delivery of training materials in basic and in-depth GMP, deviation investigations, root cause analysis (both manufacturing and clinical operations), annual product review, visual inspection equipment operation.
Coaching/Mentoring
When combined with training, coaching / mentoring provides assurance that training was effective and sustainable. It is essential to any remediation program.
Experience includes coaching / mentoring of deviation investigations (both manufacturing and laboratory), annual product reviews, manufacturing, QC lab activities
Take your Training to the Next Level
Qualification / Certification Program
To ensure competence, training alone is not enough to claim excellence in conducting deviation investigations and performing internal and supplier audits. It is essential to develop and execute a well-designed in-house qualification or certification program for your internal investigators and auditors.
Experience includes development and execution of a qualification program for investigators and QA approvers and a certification program for internal auditors.