Medical Device Employee Training - Requirements and Implementation Tips
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Deadline: February 27, 2019 | Date: February 27, 2019
Venue/Country: U.S.A
Updated: 2019-01-25 15:41:01 (GMT+9)
Call For Papers - CFP
Training is required by the FDA and ISO 13485, but determining training needs and tracking of training can be challenging, especially as companies grow. Improperly or inadequately trained employees lead to both product and process nonconformities. These can be costly, and potentially even a safety risk to users of your product, themselves or other employees. Most medical device companies are aware of this, and are generally good at specific job-related training, although often not good at documenting this training. From a regulatory perspective, training must be documented. From a company perspective, without properly assessing training needs, documenting actual training and making sure that training is effective, you may not be able to adequately assess if employees are being properly trained and to assure regulators that they are.This webinar will present specific FDA training requirements. It will focus on techniques for needs assessment and keeping records of in-house training and will also cover how experience and outside training can be integrated into this training. It will provide information and tips on best practices for assuring your employees are properly trained and you can demonstrate it.
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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