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Subscribe NewsletterGMP Training for Manufacturing and Administration Personnel
Product Id
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600060
Overview: If you read the FDA quality system regulation clause 820. 25 (personnel) it states that: "Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibi
Training shall be documented". The term "all personnel" is a very important part of this clause. Very often we provide GMP training to those individuals who work within the disciplines of engineering, regulatory and quality. Furthermore we usually depend on the quality assurance personnel or those regulatory personnel within our organization to be the key providers of information during an FDA QSIT investigation. There may be times when the FDA will want to speak with all disciplines within an organization from the CEO on down. All personnel means "all personnel", which means that anyone involved in the design, manufacture, inspection, test, packaging, and/or service of the device should have adequate training to the GMP requirements.
Another key point of Part 820.25 is: "as part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs". This aspect of a training program is often overlooked, yet would be something that the FDA will look for when performing an investigation of your facility. It is also a requirement that personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions. This webinar will provide a basic overview of the requirements of 21 CFR Part 820 for those personnel who are not normally involved within a normal training process. The 15 subparts of the CFR will be reviewed at a level consistent with administrative and hourly personnel and will provide a good overview for those disciplines not normally involved in an FDA facility investigation. Although it will be geared to those individuals who don't normally have a significant knowledge of the quality system regulations, this webinar will provide insight as to how each of the 15 subparts relates to each job discipline within a medical device manufacturer’s organization.
Training shall be documented". The term "all personnel" is a very important part of this clause. Very often we provide GMP training to those individuals who work within the disciplines of engineering, regulatory and quality. Furthermore we usually depend on the quality assurance personnel or those regulatory personnel within our organization to be the key providers of information during an FDA QSIT investigation. There may be times when the FDA will want to speak with all disciplines within an organization from the CEO on down. All personnel means "all personnel", which means that anyone involved in the design, manufacture, inspection, test, packaging, and/or service of the device should have adequate training to the GMP requirements.
Another key point of Part 820.25 is: "as part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs". This aspect of a training program is often overlooked, yet would be something that the FDA will look for when performing an investigation of your facility. It is also a requirement that personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions. This webinar will provide a basic overview of the requirements of 21 CFR Part 820 for those personnel who are not normally involved within a normal training process. The 15 subparts of the CFR will be reviewed at a level consistent with administrative and hourly personnel and will provide a good overview for those disciplines not normally involved in an FDA facility investigation. Although it will be geared to those individuals who don't normally have a significant knowledge of the quality system regulations, this webinar will provide insight as to how each of the 15 subparts relates to each job discipline within a medical device manufacturer’s organization.
Areas Covered in the seminar:
- Overview of the 21 CFR 820 Quality regulations for all levels of personnel
- Concentration on those individuals that do not normally get trained but are required to have training
- Overview of all 15 Subparts of 21 CFR 820 & there application to all levels of personnel
Who Will Benefit:
- Administrative Personnel
- Shipping and Receiving Personnel
- Program Managers
- Line Workers