We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program. Why You Should Attend Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though training is considered the “vaccine for mistakes” training is not responsible for most human error deviations. In order to make sure training programs are effective and can be ruled out as a root cause for human error deviations, we will discuss elements necessary when implementing/improving a training program. Areas Covered in the Session: GMP regulations on the training topic Agencies expectations of the training program Training general aspects Responsibilities of the training program Requirements for New employees Transferred Employees External Service Providers Training Events Skills Qualification Program (OJT) Training Assessment Retraining Training Outline/Contents GMP Technical Training On the Job Training Frequency and Topics Instructor’s Qualifications Training Curricula Training Documentation Review of Training System Effectiveness Deviations related to performance Learning Objectives: Learn key elements of the training program in regulated environment List Key Performance Indicators related to training Learn to develop a training program Learn how to measure training effectiveness Learn when training is responsible for human error deviations Who Will Benefit: Training Managers and Coordinators Operations Manufacturing Plant Engineering QA/QC Staff Process Excellence/Improvement Professionals Industrial/Process Engineers Compliance Officers Regulatory/Legislative Affairs Professionals General/Corporate Counsel Executive Management


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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
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