SDLC SOP 1100 - Documentation of Training

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SDLC SOP 1100 - Documentation of Training

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


Definitions

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:

  • seminars and conferences sponsored by professional societies, commercial training groups, or regulatory agencies
  • college courses

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

  1. All personnel performing development functions will receive initial and periodic training in the applicable SDLC SOPs and government regulations.
  2. SDLC will maintain training records that document each employee's training.Human Resources will be responsible for maintaining training records that document each employee’s training.
  3. Training records maintained by Human Resources must not contain any information that identifies particular SDLC clients or their products.
  4. Project-specific training documentation includes participant content, and documentation of reading client SOPs when applicable.This documentation should be filed appropriately in project Central Files by the trainer (or designee) or a note of cross-reference to where the documentation is filed if not in Central Files.
  5. SDLC training records must capture each employee's training, as appropriate, in
  6. Good Clinical Practice (GCP)
  • SDLC SOPs (or client SOPs if applicable)
  • Technical subjects related to current and/or future projects or products
  • Professional skills and Job-required training programs


Maintenance of Employee Records

Responsibility Activity

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.



Maintain the records such that training information can be reported at least in the following two ways:

  • Chronologically, including training program titles and employees attending
  • By employee, indicating all training received and dates.


Collect the following information for each affected employee:

  • Employee name
  • Date(s) of training programs
  • Course title and/or brief description
  • Course sponsor (and/or facilitator and duration of training



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.



Provide training information, when requested, to the following authorized individuals:

  • Senior Executives (Vice Presidents and above)
  • Directors
  • Regulatory Affairs/Quality Assurance Professionals
  • Project Managers and Line Managers
  • Training Coordinators
  • Trainers
  • Individuals (limited to the individual's training records)



Provide information contained in the training database to current or prospective clients and to regulatory authorities, when requested by an authorized individual.



Documentation of Internal Training

Responsibility Activity

Trainer

Act as training coordinator for internal training program.



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.



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.



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.


Human Resources

Place confirmation of completion of the training program into the employee's record.



Documentation of External Training

Responsibility Activity

Employee

Request permission to attend in advance of attending an external training program.A standard form may be used for this purpose.


Employee's Manager

Approve attendance of employee and forward approval to the appropriate director.


Director

Approve attendance of employee and forward approval to Human Resources.


Human Resources

Obtain further approvals according to local administrative procedures.



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.


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.


Human Resources

Place confirmation of completion of the training program into the employee's record.



Documentation of Specific Training

Responsibility Activity

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.


Related Standard Operating Procedures:

(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.)


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