The Production and Process Controls regulations [21 CFR 820.70] include the validation requirements for medical device companies which state: “When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol.All software changes shall be validated before approval and issuance.The focus behind this question is the fact that both EMA and FDA expect software that could interact with the yet-to-be validated quality system, and this would comprise of the learning management system (LMS) that stores records related to qualification and training.When a worker takes part in development and performance management activities, these should not affect the qualification of the said employee, and should fall beyond the validated condition.Since evaluation and validation are concerned with learning outcomes, certification is based upon measurable performance.Evaluation and validation cannot begin until your organization has established measurable training standards.It is felt that specifiers, contractors, manufacturers and other end-users will feel more comfortable in using installers that have completed installation training as outlined in SWR Institute’s Validated Training Program.
Trainer will ensure training systems are in place and are in compliance with internal and external policies, protocol, regulations, and requirements including Safety, Quality, NQMS, HR, OSHA, ISO, NGA, NMA, and Education and Training Pillar Methodlogy.
For it to be effective, you must approach it like an learning professional.
Here are five things to consider when setting up an employee training program.
The proposed Validated Training Program shall be submitted to SWR Institute with all of the components including a printed course outline, training manual, list of video, audio or printed references, resumes of training staff, copies of the written examinations, and a list of proposed monitors/ proctors that will be available to review the program to insure that the program follows the course outline.
Review SWR Institute Validation Committee will review the submission for compliance with the Validated Training Program requirements and approve or return the program to the applicant.