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Objective:
The objective of this Standard Operating Procedure (SOP) is to document a method for creating and maintaining training records.
Scope:
This procedure describes the methods used to document job related training received by SDLC personnel who perform pharmaceutical development functions.
Owner:
Operations
Internal Training: Includes formal classroom and self-paced training programs that are provided at a SDLC facility by SDLC employees or outside speakers.
External Training:Provided off-site and includes:
Trainer: The individual(s) conducting or sponsoring the formal/internal training program.
Project-specific Training: This is coordinated by the Project Manager (or Designee) and addresses technical project, protocol, orientation, and/or procedural issues and is study related.
Principles
Responsibility | Activity |
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Human Resources | Maintain a record that documents the training received by each employee performing a function regulated by an agency with jurisdiction over pharmaceutical development services or deliverables provided by SDLC.
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Maintain the records such that training information can be reported at least in the following two ways:
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Collect the following information for each affected employee:
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Maintain the records such that access to this information is limited only to authorized individuals.Since this training record may be part of the larger personnel database, the Human Resources individuals must exercise care that no other personnel information is revealed to persons reviewing training information.Authorization to examine training files in no way implies access to any other files in the Human Resources Department.
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Provide training information, when requested, to the following authorized individuals:
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Provide information contained in the training database to current or prospective clients and to regulatory authorities, when requested by an authorized individual.
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Responsibility | Activity |
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Trainer |
Act as training coordinator for internal training program.
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For formal (internal) seminars, lectures, or other training program, provide Human Resources (HR) with a description of the program, the names of the attendees, and the date of the program.A standard HR form may be used for this purpose.
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Internal seminars, lectures, or other training programs will be evaluated, either at the end of a single program or periodically for an on-going program, on the quality of the training.A standard HR form may be used for this purpose.
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Forward training information on each individual attending the training to the designated person in Human Resources for record keeping. A standard HR form may be used for this purpose.
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Human Resources |
Place confirmation of completion of the training program into the employee's record.
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Responsibility | Activity |
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Employee |
Request permission to attend in advance of attending an external training program.A standard form may be used for this purpose.
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Employee's Manager |
Approve attendance of employee and forward approval to the appropriate director.
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Director |
Approve attendance of employee and forward approval to Human Resources.
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Human Resources |
Obtain further approvals according to local administrative procedures.
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After all approvals are obtained, return a copy of the request with all necessary approvals to the individual requesting attendance at the external training program.
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Employee |
After participating in the external training program, notify Human Resources of completion of the training program.A standard HR form may be used for this purpose.
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Human Resources |
Place confirmation of completion of the training program into the employee's record.
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Responsibility | Activity |
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Trainer |
Document and enter information into project-specific files. Minimum information should include the date of training, the attendees and the outline of content/meeting agenda, a standard form may be used for this purpose.
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(Note: Standard HR forms, which may be used to document training, are maintained by Human Resources and can be obtained from your local Human Resources or Training and Development representative/manager.)