6. Training System Procedures
GMP Training System Procedures
$199.00
Description
Do you need to revamp your training system? Upgrade your procedures? Fill in gaps?This package will save you significant amounts of time and effort!
This set of content provides all of the processes, forms, and procedures needed to meet compliance expectations for a GMP training system. It is provided as a downloadable zip file containing 17 files – 8 procedures, 4 templates, and 5 pdf process maps/decision trees. This package will save you months of time and give you a solid starting point.
It includes a complete set of editable training system procedures and templates – 129 pages of content, including:
- 1 policy document
- 7 SOPs/procedures – all SOPs include Purpose, Scope, Roles & Responsibilities, Definitions and References sections in addition to procedural content
- 4 templates
- 11 forms
- 6 process maps & decision trees
Use them as a basis for your new procedures, or to add missing pieces to your existing procedure or system.
Documents include:
Training Policy Document (4 pages): Defines the requirements for a training system that will ensure GMP personnel have the necessary qualifications, knowledge and skills to execute their defined job responsibilities, and perform cGMP activities safely and effectively
Training System SOP (18 pages): Describes the GMP training system requirements, including:
- Identification of the processes that make up the training system
- Definition of training plans and training requirements for all personnel performing GMP functions (including contractors, and consultants)
- Exceptions to and waivers for completion of requirements
- Management of transfers, absences, failures to complete training requirements and disqualifications
- Training documentation
Annual Site Training Plan SOP (4 pages): Describes the process for creation, maintenance, and archiving, including a template for the document
Training Plan SOP (14 pages): Includes processes and documentation for:
- Creation, approval, periodic review and updating modules and curricula in the LMS
- Development of and approval for assignment of training plans to personnel
- Periodic review of training plans
- Identification of training due date and requalification requirements
Trainer Qualification SOP (12 pages): Includes the processes and documentation for:
- Selecting, assessing, and qualifying Area/OJT Trainers
- Qualification of Professional Trainers
- Changing the status of or disqualifying a previously approved Qualified Trainer
- Selection and approval of External Trainers
Training Material Implementation SOP (15 pages): Includes the processes and documentation for:
- The design, approval, evaluation and periodic review of training materials
- Control and versioning of training materials
- Training material changes
- Qualification of SMEs developing training and evaluations
Training Documentation SOP (18 pages): Includes processes and documentation to be used for:
- Department orientation discussions with new personnel
- Recording internal and external training events for both individuals and groups of trainees
- Capturing performance of training, including definition and use of performance codes
- Waiving of training requirements
- Disqualification of previously qualified personnel
On the Job Training SOP (23 pages): Includes the processes and documentation requirements for:
- Creation and implementation of performance assessment checklists (PACs), including the PAC format and content
- Control, revision and maintenance of PACs
- Using PACs in OJT
- Designating Qualified Trainers for PACs
- Managing OJT failures
4 Templates:
- Annual Site Training Plan template (1 page)
- Performance Assessment Checklist (PAC) template (6 pages)
- Department Orientation presentation template (24 pages)
- Department Orientation Checklist template (4 pages)
11 forms, included in their respective SOPs:
- Training plan assignment form
- Module/curricula form
- Trainer selection form
- Trainer evaluation form
- External trainer qualification form
- Qualified trainer status change form
- Training material approval form
- Training material periodic review form
- Individual training form
- Group training form
- Training waiver form
6 Process Maps & Decision Trees, included in their respective SOPs:
5 are not editable, as they define the process the way it should be executed – if you choose to do something different, you’ll need to map your own process, but these can serve as templates
- Process map: Training System (not editable) – defines how a GMP training system should function
- Map: Role-based curricula development (not editable) – defines the format/approach to role based curricula
- Decision process: Identification of training requirements (not editable) – defines what type of training is required for specific audiences
- Decision process: Training assignment approvers (not editable)
- Decision process: Risk-based retraining/requalification requirements
- Map: PAC identification & implementation process (not editable) – defines process steps, roles and responsibilities
Please note: While we believe our procedures are up to the standard of the most current expectations, it is the responsibility of each company to have procedures that accurately reflect their systems and processes. The purchaser is responsible for the content and accuracy of their own procedures. JGTA, LLC is not responsible for the consequences of customers modifying content of these procedures, and will not be liable for any claims resulting from use or modification of these procedures.