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Ref : 27278
Event :Conducting a life sciences documentation and training gap analysis

Date :Friday May 18th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


Further information

Conducting a life sciences documentation and training gap analysis





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.


$179 One Dial-in One Attendee $279 One Dial In - Max 10 attendees  $695 Multiple locations upto 5 dial in  

$249 Available within 24 hrs after  $299 CD/DVD will be dispatched after 


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Conducting a life sciences documentation and training gap analysis Pharmacy
areas of the organization/process that must be examined and analyzed
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