Training and Consultancy Services
Purpose
There should be an adequate number of personnel qualified by appropriate education, training and experience. Training should be regularly conducted by qualified individuals and should cover as a minimum the particular operations that the employee performs and GMP as it relates to the employee's functions. Records of training should be maintained and the effectiveness of the training should be periodically evaluated.
Prerequisites
- The facility is operating under GMP or equivalent conditions.
- Adequate number of personnel who have the need for training.
- Organization chart and job descriptions (helpful).
- Clearly defined process and process operations
Procedures
- Discuss with client about their requirements (kind of training needed).
- Prepare an offer (fixed rate based on the type of training and/or consultancy).
- Sign the contract and project commence.
- Finalize training schedule and send to customer for approval.
- Ask for customers’ specific documents to support the training (dependent on the kind of training; to make the training practical oriented)
- Organization of the training location and catering (by customer)
- Execution of the training and/or Consultancy Service on site
- Conclude the training with certificates
Topics of training
- GMP Basics (3 days general seminar for first overview about all subjects)
- Plant Qualification (2 days intensive seminar, DQ, IQ, OQ, PQ, plant design)
- Cleaning validation (2 days intensive seminar, rules and how to do)
- Risk assessment, HACCP (2 days intensive seminar)
- Good documentation Practice (2 days intensive seminar, technical-, validation-, production documentation)
- DMF, CoS, NDA, etc (1 day intensive seminar + 1 day consultation)
- Further topics on demand (every topic coming up from GMP we can provide)
Kind of trainings Trainings can be provided in several ways dependent on the demand:
- Lecture or seminar (only teaching)
- Lecture combined with training sessions
- Workshops to work together on specific topics (makes sense in the case of some relevant projects to directly work for some specific solutions)
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What is GMP
Training
