Conduct a Regulatory Documentation and Training Gap Analysis

Conduct a Regulatory Documentation and Training Gap Analysis

  CHARLES H PIERCE

  President

C. H. Paul Consulting

  When : Friday, October 08, 2021

  Time : 01 : 00 PM EST

  Duration : 60 Minutes

  Product ID : CHAP-0025

  Level : Intermediate

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Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, Lean Manufacturing, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer, and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.

This webinar will provide the best practice approach for conducting an efficient, effective, and complete regulatory documentation and training gap analysis for a regulated environment as well as developing both training materials and compliance documents that effectively serve a multitude of uses. How well an analysis is conducted impacts cost, the speed of training delivery, and the quality of the regulatory documentation produced. This webinar will guide the participant through the entire process from start to finish and will discuss how training materials and compliance documentation can be developed to meet complimentary purposes.

Areas Covered

  • Elements of regulatory documentation and training
  • How regulatory documentation and training are linked
  • Regulatory compliance documentation hierarchies
  • The gap analysis - Areas of the organization/process that must be examined and analyzed
  • Conducting the gap analysis – using subject matter experts
  • Training task characteristics that impact training delivery
  • Use of the Analysis Tool to capture the required information
  • Performance objectives, how they are developed and how they impact the training process

Course Level - Basic/Intermediate

Who Should Attend

  • Training associates
  • Training developers
  • Training managers and directors
  • Compliance managers
  • Compliance directors
  • Quality Managers and Directors

Why Should You Attend

One of the keys to both effective compliance documentation and training is to develop documents that effectively serve a multitude of purposes – minimizing required regulatory control and maximizing utilization effectiveness. The key to executing that outcome is knowing how to conduct a thorough regulatory documentation and training gap analysis.

Topic Background

The relationship between government regulations, actual job tasks performed by workers, compliance requirements, equipment maintenance and operational requirements, and process descriptions all are foundational to both the training that must be conducted in a regulated facility and the actual compliance documents that must be created to meet all regulatory requirements. How a training and documentation professional undertakes a gap analysis to determine those requirements directly influences the quality of the training developed and fielded and the completeness and relevance of the compliance documentation prepared.

Many regulated industries have a multitude of documents to meet their regulatory needs, training materials, SOPs, Work Instructions, Job Aids, and Performance Tests etc. all independently prepared complicating document control and impacting individual document effectiveness.

  • $179.00


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