Conducting a life sciences documentation and training gap analysis

03:00 PM EDT | 12:00 PM PDT | 02:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"Hear By Charles H Paul has been a regulatory and management consultant and an Instructional Technologist for 30 years"

Learn the Elements of a regulatory documentation and training program


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 an analysis to determine these 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.

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.

Why should you attend :

The secret to effective compliance documentation and technical training lies in how the analysis is conducted and how training and compliance documentation are developed as a result of that analysis. 

This webinar will provide the best practice approach for conducting an efficient, effective, and complete documentation and training 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 a regulatory documentation and training program
•      How regulatory documentation and training are linked
•      Regulatory compliance documentation hierarchies
•      Areas of the organization/process that must be examined and analyzed
•      Conducting the 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

Who will Benefit

Anyone involved in the design and development of medical devices and pharmaceuticals from R & D, compliance, training, regulatory, and engineering.

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Charles H Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues. 

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military. 

He has dedicated his entire professional career explaining the benefits of performance-based training

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